UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended
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.
(Exact name of registrant as specified in its charter)
| (State
or other jurisdiction of incorporation or organization) |
(IRS Employer Identification No.) |
(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 | ||
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. ☒
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | Accelerated filer ☐ |
| Smaller
reporting company | |
| 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
shares of common stock, par value $ per share, outstanding as of August 13, 2025
AINOS, INC.
INDEX
| 2 |
PART I - FINANCIAL INFORMATION
ITEM 1. Financial Statements
Ainos, Inc.
Condensed Balance Sheets
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable | ||||||||
| Inventory, net | ||||||||
| Other current assets | ||||||||
| Total current assets | ||||||||
| Intangible assets, net | ||||||||
| Property and equipment, net | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Contract liabilities | $ | $ | ||||||
| Convertible notes payable (including amounts of related party of and $ | ||||||||
| Accrued expenses and others current liabilities | ||||||||
| Total current liabilities | ||||||||
| Convertible notes payable - noncurrent (including amounts of related party of $ | ||||||||
| Other long-term liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $ par value; shares authorized; issued and outstanding as of June 30, 2025, and December 31, 2024, respectively | ||||||||
| Common stock, $ par value; shares authorized as of June 30, 2025, and December 31, 2024, and shares issued and outstanding as of June 30, 2025, and December 31, 2024, respectively(1) | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Accumulated other comprehensive loss | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
| (1) |
Note that all share and per-share amounts have been adjusted retroactively to reflect a 1-for-5 reverse stock split, including rounding of fractional shares.
See accompanying notes to condensed financial statements.
| 3 |
Ainos, Inc.
Condensed Statements of Operations
(Unaudited)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Cost of revenues | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Gross (loss) profit | ( | ) | ( | ) | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses
(including amounts of related party of $ | ||||||||||||||||
| Selling, general and administrative expenses | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operating | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Non-operating (expenses) income, net | ||||||||||||||||
| Interest expenses | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Issuance cost | ( | ) | ||||||||||||||
| Fair value change for senior secured convertible note | ( | ) | ( | ) | ||||||||||||
| Other income (expenses), net | ( | ) | ( | ) | ||||||||||||
| Total non-operating (expenses) income, net | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss before income taxes | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Provision for income taxes | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per common share-basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted-average shares used in computing net loss per common share-basic and diluted(1) | ||||||||||||||||
| (1) |
Note that all share and per-share amounts have been adjusted retroactively to reflect a 1-for-5 reverse stock split, including rounding of fractional shares.
See accompanying notes to condensed financial statements.
| 4 |
Ainos, Inc.
Condensed Statements of Comprehensive Loss
(Unaudited)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Translation adjustment | ( | ) | ( | ) | ||||||||||||
| Comprehensive loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
See accompanying notes to condensed financial statements.
| 5 |
Ainos, Inc.
Condensed Statements of Stockholders’ Equity
For the three months ended June 30, 2025 and 2024
(Unaudited)
| Preferred Stock | Common Stock | Common Stock - to be issued | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | ||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares(1) | Amount | Shares | Amount | Capital | Deficit | Loss | Equity | |||||||||||||||||||||||||||||||
| Balance at March 31, 2025 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||
| Issuance of stock to settle vested RSUs | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||
| Issuance of common stock from at the market offering | - | - | ||||||||||||||||||||||||||||||||||||||
| Issuance of common stock for paying consulting fee | - | - | ||||||||||||||||||||||||||||||||||||||
| Fractional shares paid out in cash for the reverse stock split | - | ( | ) | ( | ) | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Share-based compensation | - | - | - | |||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Translation adjustment | - | - | - | |||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||
| Balance at March 31, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||
| Conversion of convertible notes payable to common stock | - | - | ||||||||||||||||||||||||||||||||||||||
| Share-based compensation | - | - | - | |||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Translation adjustment | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||
| (1) | The Company effected a reverse stock split of its outstanding shares of common stock on June 30,2025, where every five shares of its common stock issued and outstanding was converted into one share of common stock. Any fractional post-split shares as a result of the reverse split were rounded down to the nearest whole post-split share. Shareholders of the Company previously authorized the Board of Directors to approve a reverse stock split at the annual meeting on 2025. All share amounts and per share amounts disclosed in this Quarterly Report on Form 10-Q have been adjusted to reflect the reverse stock split on a retroactive basis in all periods presented. |
Notes that all share and per-share amounts have been adjusted retroactively to reflect a 1-for-5 reverse stock split, including rounding of fractional shares.
See accompanying notes to condensed financial statements.
| 6 |
Ainos, Inc.
Condensed Statements of Stockholders’ Equity
For the six months ended June 30, 2025 and 2024
(Unaudited)
| Preferred Stock | Common Stock | Common Stock - to be issued | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | ||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares(1) | Amount | Shares | Amount | Capital | Deficit | Loss | Equity | |||||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||
| Issuance of stock to settle vested RSUs | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||
| Issuance of stock to special stock award | - | - | ||||||||||||||||||||||||||||||||||||||
| Issuance of common stock from at the market offering | - | - | ||||||||||||||||||||||||||||||||||||||
| Issuance of common stock for paying consulting fee | - | - | ||||||||||||||||||||||||||||||||||||||
| Fractional shares paid out in cash for the reverse stock split | - | ( | ) | ( | ) | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Share-based compensation | - | - | - | |||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Translation adjustment | - | - | - | |||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||
| Issuance of stock to settle vested RSUs | - | ( | ) | |||||||||||||||||||||||||||||||||||||
| Conversion of senior secured convertible note payable to common stock | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||
| Related party used computer equipment | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Warrants issued in connection with senior secured convertible note payable | - | - | - | |||||||||||||||||||||||||||||||||||||
| Share-based compensation | - | - | - | |||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Translation adjustment | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||
| (1) |
Note that all share and per-share amounts have been adjusted retroactively to reflect a 1-for-5 reverse stock split, including rounding of fractional shares.
See accompanying notes to condensed financial statements.
| 7 |
Ainos, Inc.
Condensed Statements of Cash Flows
(Unaudited)
| Six months ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( |
$ | ( |
||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Share-based compensation expense | ||||||||
| Stock issued for special stock bonus | ||||||||
| Issuance of common stock for paying consulting fee | ||||||||
| Issuance cost of senior secured convertible note measured at fair value | ||||||||
| Change in fair value of senior secured convertible note measured at fair value | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ( |
|||||||
| Inventory | ( |
|||||||
| Other current assets | ( |
|||||||
| Accrued expenses and other current and long-term liabilities | ( |
|||||||
| Net cash used in operating activities | ( |
( |
||||||
| Cash flows from investing activities: | ||||||||
| Purchase of property and equipment | ( |
( |
||||||
| Decrease (increase) in refundable deposits and other assets | ( |
|||||||
| Net cash used in investing activities | ( |
( |
||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from convertible notes payable, related party | ||||||||
| Proceeds from senior secured convertible notes payable | ||||||||
| Proceeds from at the market offering, net of issuance costs | ||||||||
| Payments of issuance cost of senior secured convertible note measured at fair value | ( |
|||||||
| Repayment of convertible notes payable | ( |
|||||||
| Fractional shares paid out in cash for the reverse stock split | ( |
|||||||
| Net cash (used in) provided by financing activities | ( |
|||||||
| Effect from foreign currency exchange | ( |
|||||||
| Net (decrease) increase in cash and cash equivalents | ( |
|||||||
| Cash and cash equivalents at beginning of period | ||||||||
| Cash and cash equivalents at end of period | $ | $ | ||||||
| Noncash financing and investing activities | ||||||||
| Conversion of senior secured convertible notes to common stock | $ | $ | ||||||
See accompanying notes to the condensed financial statements.
| 8 |
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 an artificial intelligence (“AI”) and healthcare company focused on the commercialization of proprietary scent digitization technology, AI-powered sensing solutions, point-of-care testing (“POCT”), and low-dose oral interferon therapeutics. We are advancing these technologies primarily through strategic partnerships.
Our core scent digitization technology platform, AI Nose, is an AI-based electronic nose system that integrates gas sensors with a proprietary smell language model (“SLM”) algorithm, aiming to enable trainable and sensitive digital olfaction. We are developing this platform to digitize scent and volatile organic compound (“VOC”) data into Smell ID, a machine-readable format designed to enable intelligent scent-based applications across industries including robotics, smart manufacturing, and healthcare. We are positioning AI Nose as AI’s olfactory system.
In parallel, we continue to develop therapeutic candidates based on VELDONA, our low-dose oral interferon platform, targeting rare, autoimmune, and infectious diseases. Our lead programs include candidates for the treatment of oral warts in HIV-positive patients, Sjögren’s syndrome, and feline chronic gingivostomatitis (“FCGS”). We have researched and developed VELDONA since our inception.
Between 2021 and 2024, we expanded our intellectual property portfolio through transactions with our controlling shareholders, including Ainos, Inc., a Cayman Islands company (“Ainos KY”), and Taiwan Carbon Nano Technology Corporation (“TCNT”). These transactions included acquisitions and license agreements primarily involving patents and patent applications related to our AI Nose platform, and point-of-care testing (“POCT”) technologies.
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
The par value of $ 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.
| 9 |
At The Market Offering Agreement
On May 31, 2024, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”), with H.C. Wainwright & Co., LLC or the Agent, pursuant to which the Company may issue and sell, from time to time, shares of its Common Stock, depending on market demand, with the Agent acting as the sales agent or principal (the “ATM Offering”). Sales of the Common Stock may be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended (the “Securities Act”), including, without limitation, sales made directly on or through the Nasdaq Capital Market. The Agent will use its commercially reasonable efforts to sell the Shares requested by the Company to be sold on its behalf, consistent with the Agent’s normal trading and sales practices, under the terms and subject to the conditions set forth in the ATM Agreement. The Company has no obligation to sell any of the Shares. The Company may instruct the Agent not to sell the Shares if the sales cannot be effected at or above the price designated by the Company from time to time and the Company may at any time suspend sales pursuant to the ATM Agreement.
The
Company will pay the Agent placement fee of
The
aggregate market value of Shares eligible for sale in the ATM Offering and under the ATM Agreement will be subject to the limitations
of General Instruction I.B.6 of Form S-3, to the extent required under such instruction. The prospectus supplement filed with the SEC
on July 11, 2024, is offering Shares having an aggregate offering price of $
The Company intends to use the net proceeds from the offering to fund the continued development of its product candidate and for general corporate purposes and working capital. The precise amount and timing of the application of these proceeds will depend upon a number of factors, such as the timing and progress of our research and development efforts, our funding requirements and the availability and costs of other funds.
As
of June 30, 2025, the Company sold an aggregate of shares of the Company’s common stock under the ATM facility, and received
$
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, 2024 contained in the Annual Report on Form 10-K filed with the SEC on March 7, 2025.
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, 2025 are not necessarily indicative of the results to be expected for any subsequent quarter, the year ending December 31, 2025, 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, 2024.
| 10 |
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, 2025, the Company had cash and cash equivalents of $
On
May 31, 2024, the Company entered into an At The Market Offering Agreement, or sales agreement, with H.C. Wainwright & Co., LLC or
Wainwright, pursuant to which the Company may issue and sell, from time to time, shares of its common stock, the aggregate market value
of Shares eligible for sale in the Offering and under the ATM Agreement will be subject to the limitations of General Instruction I.B.6
of Form S-3, to the extent required under such instruction. The prospectus supplement filed with the SEC on July 11, 2024, is offering
Shares having an aggregate offering price of $
For
the six months ended June 30, 2025, the Company generated a net loss of $
The
financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business. The Company has incurred net operating losses since inception and has an accumulated deficit
as of June 30, 2025 of $
Segments
Operating
segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed
by the chief operating decision maker (the “CODM”) in deciding how to allocate resources to an individual segment and in
assessing performance. The Company’s Chief Executive Officer is the Company’s CODM. The CODM reviews financial information
prepared on the basis of accounting policy disclosed in its annual financial statement for purposes of making operating decisions, allocating
resources, and evaluating financial performance of the Company. As such, the Company has determined that it operates as
| 11 |
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.
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.
Recent Accounting Pronouncements Adopted
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07, which is applicable to entities with a single reportable segment, will primarily require enhanced disclosures about significant segment expenses and enhanced disclosures in interim periods. The guidance in ASU 2023-07 will be applied retrospectively and is effective for annual reporting periods in fiscal years beginning after December 15, 2023 and interim reporting periods in fiscal years beginning after December 31, 2024, with early adoption permitted. The Company does not expect the adoption of this standard to have a material impact on the Company’s unaudited condensed financial statements.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 is intended to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning after December 15, 2024. The Company does not expect the adoption of this standard to have a material impact on the Company’s unaudited condensed financial statements.
Accounting Standards Issued but Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation and amortization) included in certain expense captions presented on the statement of operations. The guidance in this ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its financial statements and disclosures.
3. Cash and Cash Equivalents
As
of June 30, 2025 and December 31, 2024, 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 $
| 12 |
4. Inventory
Inventory stated at cost, net of reserve, consisted of the following:
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Raw materials | $ | $ | ||||||
| Work in process | ||||||||
| Finished goods | ||||||||
| Total | $ | $ | ||||||
Inventory write-downs to estimated net realizable values were for the three and six months ended June 30, 2025, and the three and six months ended June 30, 2024.
5. Convertible Notes Payable and Other Notes Payable
As of June 30, 2025 and December 31, 2024, the respective notes payable were as follows:
June 30, 2025 | December 31, 2024 | |||||||
| March 2025 Convertible Notes, related party –noncurrent (ASE Note) | $ | $ | ||||||
| March 2025 Convertible Notes, related party –current (ASE Note) | ||||||||
| March 2025 Convertible Notes –current (Lee Note) | ||||||||
| May 2027 Convertible Notes, related party – noncurrent (ASE Note) | ||||||||
| $ | $ | |||||||
May 2027 Convertible Notes and Warrant Purchase Agreement
On
May 3, 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
March 2025 Convertible Notes
On
March 13, 2023, the Company entered into two convertible promissory note purchase agreements pursuant to Regulation S of the Securities
Act of 1933, as amended, in the total principal amount of $
Convertible Note Issued to Li-Kuo Lee (the “Lee Note”)
The
Company issued a convertible note in the principal amount of $
On
March 12, 2025, the Company entered into an amendment to the Convertible Note (the “Convertible Note Amendment”) with Li-Kuo
Lee to extend the maturity date to
On
April 30, 2025, the Company repaid the full principal with accrued interest aggregate amount $
| 13 |
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
$
On
March 10, 2025, the Company entered into an amendment to the Convertible Note (the “Convertible Note Amendment”) with ASE
Test to (1) extend the maturity date to
The
March 2025 Convertible Notes bearing interest at the rate of
The
total interest expense of convertible notes payable, other notes payable, March 2025 Convertible Notes and May 2027 Convertible Notes
for the three and six months ended June 30, 2025 was $
6. Stockholders’ Equity
Reverse Stock Splits
To
comply with Nasdaq’s minimum $ per share continued listing rules, the Company filed a Certificate of Amendment to its Restated
Certificate of Formation on May 16, 2025, to apply for reverse stock split of the Company’s common stock at a ratio of
Preferred Stock
The Company increased authorized shares of preferred stock from shares to 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. shares of preferred stock were issued and outstanding as of June 30, 2025 and December 31, 2024.
Common Stock
During the six months ended June 30, 2025, the Company issued an additional shares of common stock as a result of delivering shares to settle vested RSUs, shares to settle vested special stock awards, shares to settle for ATM transaction, shares to compensate consultant but the shares were offset by fractional shares paid out in cash for the reverse stock split. As of June 30, 2025, there were shares of common stock legally issued and outstanding.
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Warrants
As of June 30, 2025 and December 31, 2024, warrants issued and outstanding in connection with financing are summarized as below:
| June 30, | December 31, | |||||||
| (In number of shares) | 2025 | 2024 | ||||||
| Lind Warrant with exercise price from $ | ||||||||
| Public warrant with exercise price of $ | ||||||||
| Representative’s warrant with exercise price of $ | ||||||||
| Placement agent warrant with exercise price of $ | ||||||||
| ASE Warrant with exercise price of $ | ||||||||
| Total | ||||||||
The
Company issued the Lind Warrants on September 28, 2023 in connection with the private placement of the Lind Note. The Company further
issued
As
disclosed in Note 1, the Company issued public warrants together with common 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
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 “ASC 480”), 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, 2025, of the warrants have been exercised nor have they 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 VELDONA Pet 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.
| 15 |
and $
The
Company recognized the revenue from sales of VOC sensing products related to NISD co-development during the six months ended June 30,
2025 and 2024 that was included in the contract liability balance at the beginning of each period were $
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.
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 shares of common stock, including shares that remained available for grant under the 2021 Stock Incentive Plan. On July 19, 2024, the Company filed Form S-8 to increase the aggregate number of shares may be issued to shares of common stock including shares that remained available for grant under the 2021 Stock Incentive Plan. On April 4, 2025, the Company filed Form S-8 to increase the aggregate number of shares that may be issued to shares of common stock. As of June 30, 2025, 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”). A total of shares of common stock have made available for issuance under the ESPP. During the period from January 1, 2024 up to the date that the prior plan was superseded by the 2023 SIP, shares were granted under the 2021 ESPP.
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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, 2025 and for the three and six months ended June 30, 2024 were as follows:
| 2025 | 2024 | |||||||||||||||
| Number of Shares | Weighted- Average Fair | Number of Shares | Weighted- Average Fair Share | |||||||||||||
| Unvested balance at January 1 | $ | $ | ||||||||||||||
| RSUs granted | $ | $ | ||||||||||||||
| RSUs vested | ( | ) | $ | ( | ) | $ | ||||||||||
| RSUs forfeited | $ | ( | ) | $ | ||||||||||||
| Unvested balance at March 31 | $ | $ | ||||||||||||||
| RSUs granted | $ | $ | ||||||||||||||
| RSUs vested | ( | ) | $ | $ | ||||||||||||
| RSUs forfeited | $ | ( | ) | $ | ||||||||||||
| Unvested balance at June 30 | $ | $ | ||||||||||||||
Stock Options and Warrants
During the three and six months ended June 30, 2025 and 2024, shares were granted, forfeited, expired or exercised. As of June 30, 2025, there were shares in the form of stock options and shares in the form of warrants outstanding, and shares of the options and 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, 2025 was $ and $ respectively, compared to the three and six months ended June 30, 2024 amount of $ and $ respectively.
As of June 30, 2025, the total unrecognized compensation cost related to outstanding RSUs, stock options and warrants was $, which the Company expects to recognize over a weighted-average period of years.
9. Income Taxes
The Company did not record a federal, state, or foreign income tax provision or benefit for the three months ended June 30, 2025 and 2024 due to the expected loss before income taxes to be incurred for the years ended December 31, 2025 and 2024, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets due to its historical deficit.
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| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net loss attributable to common stockholders, basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted | ||||||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Option and RSUs to purchase common stock | ||||||||||||||||
| Warrants to purchase to common stock | ||||||||||||||||
| Convertible note to purchase common stock | ||||||||||||||||
| Total potential shares | ||||||||||||||||
11. Related Party Transactions
The following is a summary of related party transactions that met our disclosure threshold:
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, 2025 were $
The company paid off the KY Note during the years 2023 and 2024.
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 $
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, 2025, there were no such commitments or contingencies.
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13. Subsequent Events
Ainos Secures $2.1 Million Order With ASE
On
August 6, 2025, the Company announced it has secured a three-year subscription-based order valued at $
Under the agreement, Ainos will deploy 1,400 AI Nose units across ASEH’s three major manufacturing sites in Taiwan. Through this rollout, Ainos will launch its SmellTech-as-a-Service model to enhance ASEH’s smart manufacturing initiatives, enabling AI-powered scent intelligence designed to improve process stability, support predictive maintenance, and increase operational safety.
Additional ATM offering
During
the period from July 1, 2025 to August 13, 2025, the Company sold
Nasdaq Deficiency Notice
As previously reported, on July 15, 2024, the Company received a deficiency letter from the 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 $ per share required for continued listing on The Nasdaq Capital Market pursuant to the Rule and the Company had been given 180 calendar days, or until January 13, 2025, to regain compliance with the Rule. Pursuant to the Written Notification, the Company had until July 14, 2025 to meet the minimum bid price requirement.
On July 15, 2025, the Company received notice from Nasdaq confirming that Ainos’ common stock maintained a closing bid price of $ or higher for ten consecutive business days, from June 30, 2025 to July 14, 2025. According to the notice, the Company has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2), and this matter is now officially closed.
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, 2024 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, 2024 (the “2024 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 2024 Annual Report, “Part II. Item 1A. Risk Factors” in this Quarterly Report, and elsewhere in this Quarterly Report, that could cause actual results to differ materially from historical results or anticipated results.
When used in this Quarterly Report, all references to “Ainos,” the “Company,” “we,” “our” and “us” refer Ainos, Inc.
Overview
Ainos, Inc. (the “Company”), incorporated in the State of Texas in 1984, is an artificial intelligence (“AI”) and healthcare company focused on the commercialization of proprietary scent digitization technology, AI-powered sensing solutions, point-of-care testing (“POCT”), and low-dose oral interferon therapeutics. We are advancing these technologies primarily through strategic partnerships.
Our core scent digitization technology platform, AI Nose, is an AI-based electronic nose system that integrates gas sensors with a proprietary smell language model (“SLM”) algorithm, aiming to enabling trainable and sensitive digital olfaction. We are developing this platform to digitize scent data, including volatile organic compound (“VOC”), into Smell ID, a machine-readable format designed to enable intelligent scent-based sensing across industries including robotics, smart manufacturing, and healthcare. We are positioning AI Nose to ultimately become AI’s nose.
In parallel, we continue to develop therapeutic candidates based on VELDONA, our low-dose oral interferon platform, targeting rare, autoimmune, and infectious diseases. Our lead programs include candidates for the treatment of oral warts in HIV-positive patients, Sjögren’s syndrome, and feline chronic gingivostomatitis (“FCGS”). We have researched and developed VELDONA since our inception.
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Between 2021 and 2024, we expanded our intellectual property portfolio through transactions with our controlling shareholders, including Ainos, Inc., a Cayman Islands company (“Ainos KY”), and Taiwan Carbon Nano Technology Corporation (“TCNT”). These transactions included acquisitions and license agreements primarily involving patents and patent applications related to our AI Nose platform, and POCT technologies.
While our AI Nose technology was initially developed for healthcare applications, we are actively expanding its use into other sectors, including robotics and industrial environments by forming strategic relationships.
Our Pipeline
We structure our development pipeline around three core platforms—AI Nose, POCT, and VELDONA—each designed to generate revenue through commercialization, partnerships, and/or licensing.
Our products are at different stages of development. For AI Nose, we expect to enter commercial pilot phase across industrial, robotics, and long-term care environments over the second half of 2025. For VELDONA, our oral interferon platform, we plan to enter Taiwan clinical trials for two lead indications, HIV-related oral warts and Sjögren’s syndrome. The HIV oral wart program has received Orphan Drug Designation from the U.S. FDA. Our POCT portfolio includes clinical-stage tools such as Ainos Flora, while legacy products, including our COVID-19 test kits, have been discontinued.
1. AI Nose – Digital Olfaction Platform
AI Nose is our proprietary digital olfaction platform. We develop integrated hardware solutions with third-party gas sensors and our AI algorithm which we refer to as the smell language model (SLM). It aims to digitize scent and volatile organic compound (VOC) profiles into structured data (“Smell ID”) for analysis and classification.
While we initially applied AI Nose in healthcare through point-of-care testing (POCT) devices, we are actively expanding its use into industrial and robotics settings. Through July 2025, we have formed several strategic partnerships to deploy AI Nose across a range of environments.
We are working with ugo, Inc., a Japanese robotics company, to integrate AI Nose into autonomous robots for environmental monitoring, safety, and healthcare support. With ASE Technology Holding Co., Ltd., a Taiwan-based global semiconductor packaging and testing company, we are evaluating AI Nose deployment across key manufacturing sites to enable real-time anomaly detection and process monitoring. We are also collaborating with Kenmec Mechanical Engineering Co., Ltd., a Taiwan-based provider of automation and smart logistics solutions, to integrate AI Nose into smart factory ecosystems, including robotics, HVAC systems, public infrastructure, airports, logistics, and healthcare applications. Kenmec’s subsidiary will manufacture AI Nose devices under this partnership.
In addition, we are partnering with Solomon Technology Corporation (“Solomon”), a Taiwan-based company specializing in machine vision, industrial AI, and smart automation. Solomon is marketing AI Nose on a non-exclusive basis to customers in semiconductors, petrochemicals, autonomous mobile robots (AMRs), defense, and healthcare. Together, we are exploring ways to combine AI Nose with Solomon’s machine vision and inspection technologies.
In parallel, we are co-developing a VOC sensing platform with Nisshinbo Micro Devices Inc. (NISD) and Taiwan Inabata Sangyo Co. to build compact, high-performance sensors for telehealth, automotive, industrial safety, and environmental monitoring. Our current efforts currently focus on semiconductor and long-term care applications.
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2. Point-of-Care Testing (POCT)
Our POCT products aim to provide simple, effective, and telehealth-friendly tests that deliver results within minutes. Our detection platforms include VOC sensing powered by AI Nose, lateral flow immunochromatographic assays, and nucleic acid technologies. We are currently prioritizing development based on VOC sensing, including the following:
| ● | Long-term Care Monitoring: We are applying AI Nose to provide telehealth-friendly, non-invasive monitoring of long-term care patients, including detection of bowel movements through scent analysis. Pilot deployments are planned in Japan and Taiwan. |
| ● | Ainos Flora: A non-invasive VOC-based test designed to assess female vaginal health and detect certain sexually transmitted infections (STIs). A companion mobile app is in development. Clinical studies are ongoing in Taiwan, and we are exploring commercialization through strategic partners. |
| ● | Ainos Pen: A portable, cloud-connected breath analyzer for general wellness and health monitoring. It is designed to support rapid health assessments and telehealth consultations. |
| ● | CHS430 Device: A VOC-based diagnostic system under development to detect ventilator-associated pneumonia (VAP) non-invasively, with results expected in minutes. |
| ● | COVID-19 Antigen Rapid Test Kit: We previously marketed COVID-19 antigen test kits in Taiwan under emergency use authorization issued by the Taiwan Food and Drug Administration (TFDA) to TCNT, the product manufacturer. We ceased selling this product in the first quarter of 2024. |
3. VELDONA – Low-Dose Oral Interferon Therapeutics
VELDONA is our proprietary low-dose oral interferon platform targeting rare, autoimmune, and infectious diseases across both human and animal health.
Our human pipeline includes oral drug candidates for the treatment of oral warts in human immunodeficiency virus (HIV) seropositive patients, Sjögren’s syndrome, common cold, influenza, and mild COVID-19 symptoms. We have conducted Phase 2 studies for all programs except for COVID-19. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for our VELDONA formulation as a potential treatment for oral warts in HIV-seropositive patients. Our near-term focus is on two lead indications, with clinical studies underway in Taiwan: oral warts in human immunodeficiency virus (HIV) seropositive patients and Sjögren’s syndrome.
In veterinary health, we are conducting clinical studies in Taiwan for feline chronic gingivostomatitis (FCGS), a chronic oral inflammatory condition. We believe interim results from these trials have shown symptom improvement and reduced reliance on steroid use. In addition, in Taiwan, we market VELDONA Pet, a supplement formulated to support canine and feline health, including gums, skin, eyes, and allergy-related conditions.
Commercialization and Development Priorities
Our top near-term priority is scaling the AI Nose platform in industrial, robotics, and long-term care settings, through our partnerships and supported by a subscription-based model that aims to offer AI-driven scent analytics and hardware services. This Smelltech-as-a-Service (SaaS) approach is designed to generate recurring revenue, while we continue targeted, capital-efficient clinical validation of Ainos Flora in Taiwan and explore potential partnerships or licensing opportunities.
In parallel, we are advancing select VELDONA programs through cost-effective clinical studies in Taiwan, balancing development progress with capital discipline and exploring potential licensing or partnership opportunities.
We may reprioritize programs based on funding availability, regulatory progress, or market conditions.
As of June 30, 2025, we had available cash and cash equivalents of $1,223,184. We anticipate business revenues and external financing options, if necessary, 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.
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Recent Development
Effective June 30, 2025, at 5:01 a.m., Central time (the “Effective Time”), the Company filed a certificate of amendment (the “Certificate of Amendment”) to amend its Restated Certificate of Formation, as amended, with the Secretary of the State of Texas, to effect a reverse stock split of the Company’s common stock at a ratio of 1-for-5 (the “Reverse Stock Split”).
The terms of the Reverse Stock Split are such that every five shares of the Company’s issued and outstanding common stock were automatically combined into one issued and outstanding share of common stock, without any change in par value per share. Holders of fractional shares were paid out in cash for the fractional portion. No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who would otherwise be entitled to a fraction of one share as a result of the Reverse Stock Split instead received an amount in cash equal to such fraction of a share multiplied by the closing sale price of common stock on Nasdaq on June 27, 2025, as adjusted for the Reverse Stock Split. The number of outstanding options and warrants was adjusted accordingly. The Reverse Stock Split does not otherwise modify any rights or preferences of the Company’s common stock.
Effective at market open on June 30, 2025, the Company’s common stock began trading on a split-adjusted basis on Nasdaq.
Results of Operations for Quarter Ended June 30, 2025 (“Q2 2025”) and June 30, 2024 (“Q2 2024”):
| Three months ended June 30, | Change | |||||||||||||||
| 2025 | 2024 | Amount | % | |||||||||||||
| Revenues | $ | 4,663 | $ | - | $ | 4,663 | - | % | ||||||||
| Cost of revenues | (937 | ) | (25,373 | ) | 24,436 | (96 | )% | |||||||||
| Gross profit (loss) | 3,726 | (25,373 | ) | 29,099 | (115 | )% | ||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 1,911,800 | 1,978,756 | (66,956 | ) | (3 | )% | ||||||||||
| Selling, general and administrative expenses | 1,837,613 | 1,044,880 | 792,733 | 76 | % | |||||||||||
| Total operating expenses | 3,749,413 | 3,023,636 | 725,777 | 24 | % | |||||||||||
| Loss from operations | (3,745,687 | ) | (3,049,009 | ) | (696,678 | ) | 23 | % | ||||||||
| Non-operating (expenses) income, net: | ||||||||||||||||
| Interest expense | (177,957 | ) | (118,759 | ) | (59,198 | ) | 50 | % | ||||||||
| Fair value change for senior secured convertible note | - | (66,844 | ) | 66,844 | (100 | )% | ||||||||||
| Other (expenses) income, net | (161,346 | ) | 39,590 | (200,936 | ) | (508 | )% | |||||||||
| Total non-operating expenses, net | (339,303 | ) | (146,013 | ) | (193,290 | ) | 132 | % | ||||||||
| Net loss before income taxes | (4,084,990 | ) | (3,195,022 | ) | (889,968 | ) | 28 | % | ||||||||
| Provision for income taxes | - | - | - | |||||||||||||
| Net loss | $ | (4,084,990 | ) | $ | (3,195,022 | ) | $ | (889,968 | ) | 28 | % | |||||
Revenues, Cost and Gross Loss
The Company reported $4,663 and nil in revenue in Q2 2025 and Q2 2024, respectively, from product sales of VELDONA pet supplements in Taiwan.
The cost of revenue related to product sales in Q2 2025 was $937 compared to $25,373 in Q2 2024. The decrease in cost of revenue was due to lower sales volume for VELDONA pet supplements during the reporting period, as the Company shifts operational focus to AI Nose platform.
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The share-based compensation expense and the depreciation expense for manufacturing in Q2 2025 and Q2 2024 were nil and $4,516, respectively. When excluding these non-cash cost, cost of revenue decreased to $937 in Q2 2025 compared to $20,857 in Q2 2024.
Gross profit from product sales in Q2 2025 was $3,726 as compared to $25,373 gross loss from product sales in Q2 2024. The increase in gross profit was due to increase the sale volume.
When excluding these non-cash costs, gross profit were $3,726 in Q2 2025 compared to $20,857 gross loss in Q2 2024.
Research and Development (R&D) Expenses
R&D expenses in Q2 2025 and Q2 2024 were $1,911,800 and $1,978,756, respectively. The decrease of $66,956 (3%) was due to reduced expenses associated with co-research for technology and product and staffing expenditures (including share-based compensation), partially offset by increased clinical trial fees. We expect that our R&D expenses related to clinical trials will continue to grow as we further develop AI Nose, VOC POCT and VELDONA drug candidates.
The share-based compensation expense and the depreciation and amortization expense in Q2 2025 and Q2 2024 were $1,209,343 and $1,276,777, respectively. When excluding these non-cash expenses, R&D expenses increased to $702,457 in Q2 2025 from $701,979 in Q2 2024.
Selling, General and Administrative (SG&A) Expenses
SG&A expenses were $1,837,613 and $1,044,880 in Q2 2025 and Q2 2024, respectively, reflecting an increase of $792,733 (76%) due to a significant increase in share-based compensation offset by a decrease in professional expenses and SEC related fees.
The share-based compensation expense and the depreciation and amortization expense in Q2 2025 and Q2 2024 were $1,309,358 and $338,669 respectively. When excluding these non-cash expenses, SG&A expenses decreased to $528,255 in Q2 2025 compared to $706,211 in Q2 2024.
Operating Loss
The Company’s operating loss was $3,745,687 and $3,049,009 in Q2 2025 and Q2 2024, respectively, reflecting a $696,678 (23%) increase in operating loss between the reporting periods. 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 Q2 2025, interest expense was $177,957 compared to $118,759 in Q2 2024. The increase in interest expense was due to accrued interest for convertible notes issued in May 2024 has a higher principal amount compared to the same period in 2024.
Net Loss
Net loss was $4,084,990 in Q2 2025 compared to $3,195,022 in Q2 2024, resulting in a $889,968 (28%) increase in net loss attributable to our shareholders of common stock. The net loss was due to exchange rate fluctuations experienced by the company in 2025 Q2 and expanding operating expense as we continued to invest resources to execute our growth strategy and product roadmap to improve our profitability.
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Results of Operations for Six Months Ended June 30, 2025 (“H1 2025”) and June 30, 2024 (“H1 2024”):
| Six months ended June 30, | Change | |||||||||||||||
| 2025 | 2024 | Amount | % | |||||||||||||
| Revenues | $ | 110,870 | $ | 20,729 | $ | 90,141 | 435 | % | ||||||||
| Cost of revenues | (19,170 | ) | (52,127 | ) | 32,957 | (63 | )% | |||||||||
| Gross profit (loss) | 91,700 | (31,398 | ) | 123,098 | (392 | )% | ||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 3,635,884 | 4,063,404 | (427,520 | ) | (11 | )% | ||||||||||
| Selling, general and administrative expenses | 3,364,374 | 2,074,298 | 1,290,076 | 62 | % | |||||||||||
| Total operating expenses | 7,000,258 | 6,137,702 | 862,556 | 14 | % | |||||||||||
| Loss from operations | (6,908,558 | ) | (6,169,100 | ) | (739,458 | ) | 12 | % | ||||||||
| Non-operating (expenses) income, net: | ||||||||||||||||
| Interest expense | (358,402 | ) | (167,455 | ) | (190,947 | ) | 114 | % | ||||||||
| Issuance cost of senior secured convertible note measured at fair value | - | (138,992 | ) | 138,992 | (100 | )% | ||||||||||
| Fair value change for senior secured convertible note | - | (98,412 | ) | 98,412 | (100 | )% | ||||||||||
| Other (expenses) income, net | (104,052 | ) | 64,127 | (168,179 | ) | (262 | )% | |||||||||
| Total non-operating expenses, net | (462,454 | ) | (340,732 | ) | (121,722 | ) | 36 | % | ||||||||
| Net loss before income taxes | (7,371,012 | ) | (6,509,832 | ) | (861,180 | ) | 13 | % | ||||||||
| Provision for income taxes | - | - | - | |||||||||||||
| Net loss | $ | (7,371,012 | ) | $ | (6,509,832 | ) | $ | (861,180 | ) | 13 | % | |||||
Revenues, Cost and Gross Loss
The Company reported $110,870 and $20,729 in revenue in H1 2025 and H1 2024, respectively, from product sales of VELDONA pet supplements in Taiwan and VOC sensing products related to NISD co-development. The increase in revenue was due to realization of $110,379 in revenues from sales of VOC sensing products related to NISD co-development.
The cost of revenue related to product sales in H1 2025 was $19,170 compared to $52,127 in H1 2024. The decrease in cost of revenue was due to a change in product compositions.
The share-based compensation expense and the depreciation expense for manufacturing in H1 2025 and H1 2024 were nil and $9,032, respectively. When excluding these non-cash cost, cost of revenue decreased to $19,170 in H1 2025 compared to $43,095 in H1 2024.
Gross profit from product sales in H1 2025 was $91,700 as compared to $31,398 gross loss from product sales in H1 2024. The increase in gross profit was due to a change in product compositions.
When excluding these non-cash costs, gross profits were $91,700 in H1 2025 compared to $22,366 gross loss in H1 2024.
Research and Development (R&D) Expenses
R&D expenses in H1 2025 and H1 2024 were $3,635,884 and $4,063,404, respectively. The decrease of $427,520 (11%) was due to decreased expenses associated with clinical trial fees, co-research for technology and product and staffing expenditures (including share-based compensation). We expect that our R&D expenses related to clinical trials will continue to grow as we further develop AI Nose, VOC POCT and VELDONA drug candidates.
The share-based compensation expense and the depreciation and amortization expense in H1 2025 and H1 2024 were $2,402,213 and $2,561,120, respectively. When excluding these non-cash expenses, R&D expenses decreased to $1,233,671 in H1 2025 from $1,502,284 in H1 2024.
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Selling, General and Administrative (SG&A) Expenses
SG&A expenses were $3,364,374 and $2,074,298 in H1 2025 and H1 2024, respectively, reflecting an increase of $1,290,076 (62%) due to a significant increase in share-based compensation offset by a decrease in professional expenses and SEC related fees.
The share-based compensation expense and the depreciation and amortization expense in H1 2025 and H1 2024 were $2,211,158 and $676,622 respectively. When excluding these non-cash expenses, SG&A expenses decreased to $1,153,216 in H1 2025 compared to $1,397,676 in H1 2024.
Operating Loss
The Company’s operating loss was $6,908,558 and $6,169,100 in H1 2025 and H1 2024, respectively, reflecting a $739,458 (12%) increase in operating loss between the reporting periods. This increase reflects our continued to invest resources to execute our growth strategy and advance our product roadmap to improve our profitability.
Interest Expense and Issuance Cost of Convertible Note
In H1 2025, interest expense was $358,402 compared to $167,455 in H1 2024. The increase in interest expense was due to accrued interest for convertible notes issued in May 2024 has a higher principal amount compared to the same period in 2024.
Net Loss
Net loss was $7,371,012 in H1 2025 compared to $6,509,832 in H1 2024, resulting in a $861,180 (13%) increase in net loss attributable to our shareholders of common stock. The net loss was due to exchange rate fluctuations experienced by the company in 2025 Q2 and expanding operating expense as 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, 2025 and December 31, 2024, the Company had available cash of $1,223,184 and $3,892,919, respectively.
The following table summarizes our cash flow during the six months period ended June 30, 2025 and 2024:
| Six months ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Net cash used in operating activities | (2,575,000 | ) | (3,468,892 | ) | ||||
| Net cash used in investing activities | (18,045 | ) | (119,792 | ) | ||||
| Net cash (used in) provided by financing activities | (280,902 | ) | 9,777,500 | |||||
Operating activities:
Cash (used in) provided operating activities decreased by $893,892 during the H1 of 2025 compared to the H1 of 2024. Our net loss for the H1 of 2025 increased by $861,180 primarily due to the company experiencing exchange rate fluctuations and expanding operating expense. 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, issuance cost of secured convertible note, and change in fair value of senior secured convertible note, issuance common stock for paying consulting fees increased approximately by $1,204,200; | |
| ● | Working capital injected into accounts receivable, inventories and other current assets decreased by approximately $196,000; and | |
| ● | Working capital injected into accrued expenses, operating lease liabilities, contract liabilities and other current and long-term liabilities increased by approximately $746,900. |
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Investing activities
Cash used for investing activities were $18,045 and $119,792 during the H1 of 2025 and the H1 of 2024, respectively. The decrease was due to a reduction in refundable deposits and other noncurrent assets offset by increase in purchases of property and equipment.
Financing activities
Cash (used in) provided by financing activities were $(280,902) and $9,777,500 during the H1 of 2025 and the H1 of 2024, respectively. The $10,058,402 decrease was primarily reflected by the following:
| ● | Proceeds from convertible notes and other notes payable financing decreased by $9,875,000; and | |
| ● | Proceeds from at the market offering, net of issuance costs increased by $719,358; and | |
| ● | Payments of issuance cost of senior secured convertible note measured at fair value decreased by $97,500. | |
| ● | Repayments of convertible note increased by $1,000,000. | |
| ● | Fractional shares paid out in cash for the reverse stock split increase by $260 |
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 2024 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.
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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, 2025.
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 2024 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 2024 Annual Report. Other than the following risk factor, there have been no material changes from the risk factors previously disclosed in our 2024 Annual Report, other than the risk factor set forth below.
Fluctuating foreign currency and exchange rates may negatively impact our business, results of operations, and financial position.
Due to our foreign operations, a portion of our business is denominated in foreign currencies. As a result, fluctuations in foreign currency and exchange rates may have an impact on our business, results of operations and financial position. Foreign currency exchange rates have fluctuated and may continue to fluctuate. Significant foreign currency exchange rate fluctuations may negatively impact our international revenue, which in turn would affect our consolidated revenue. Currencies may be affected by internal factors, general economic conditions and external developments in other countries, all of which can have an adverse impact on a country’s currency. We cannot predict whether we will incur foreign exchange losses in the future. Further, significant foreign exchange fluctuations resulting in a decline in the respective local currency may decrease the value of our foreign assets, as well as decrease our revenues and earnings from our foreign subsidiaries, which would reduce our profitability and adversely affect our financial position.
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Policy changes affecting international trade could adversely impact the demand for our products and our competitive position.
Changes in government policies on foreign trade and investment can affect the demand for our products and services, impact the competitive position of our products and services or prevent us from being able to sell products and services in certain countries. The implementation of more restrictive trade policies, such as more detailed inspections, higher tariffs, import or export licensing requirements, economic sanctions, anti-boycott laws, exchange controls or new barriers to entry could have a material adverse effect on our business, financial condition, results of operations and cash flows. In addition, the Trump Administration has announced tariffs on certain imports from Canada, Mexico and the EU, among others, that could affect the demand for our products. Such tariffs and any retaliatory tariffs (including those announced by China, Canada and Mexico) may put upwards pressure on prices in other jurisdictions from which we purchase product components, which could reduce our ability to offer competitive pricing to potential customers. We cannot predict what changes to trade policy will be made by the Trump Administration, the U.S. Congress or other governments, including whether existing tariff policies will be maintained or modified or whether the entry into new bilateral or multilateral trade agreements will occur, nor can we predict the effects that any such changes would have on our business or the global economy. Changes in U.S. trade policy, or threat of such changes, have resulted and could again result in reactions from U.S. trading partners, including adopting responsive trade policies making it more difficult or costly for us to export our products or import products or product components from countries where we currently purchase products or product components or sell products or services. Such changes, or threatened changes, to trade policy or in laws and policies governing foreign trade, and any resulting negative sentiments towards the United States as a result of such changes, could materially and adversely affect our business, financial condition, results of operations and liquidity.
ITEM 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities
Recent Sales of Unregistered Equity Securities
None in this quarter.
Issuer Purchase of Equity Securities
Not applicable.
Use of Proceeds of Registered Securities
Not applicable.
ITEM 3. Defaults Upon Senior Securities
None
ITEM 4. Mine Safety Disclosures
Not applicable
ITEM 5. Other Information
None
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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 | Certificate of Amendment to the Restated Certificate of Formation of Ainos, Inc., as filed with the Texas Secretary of State on June 6, 2025 | 7/1/2025 | 8-K | 3.1 | Certificate of Amendment | |||||||
| 31.1 | Certification of Chief Executive Officer Pursuant to Rule 13a- 14(a) / 15d – 14(a) | x | ||||||||||
| 31.2 | Certification of Chief Financial Officer Pursuant to Rule 13a- 14(a) / 15d – 14(a) | 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 | ||||||||||
| 100 | Inline XBRL – Related Documents | x | ||||||||||
| 101.INS | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the XBRL document. | x | ||||||||||
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | x | ||||||||||
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase | x | ||||||||||
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase | x | ||||||||||
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase | x | ||||||||||
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase | x | ||||||||||
| 104.1 | Cover Page Interactive Data File | x | ||||||||||
The exhibits listed in the Exhibit Index are filed or incorporated by reference as part of this filing.
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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 13, 2025 | By: | /s/ Chun-Hsien Tsai |
| Chun-Hsien Tsai, Chairman of the Board, President, and Chief Executive Officer | ||
| Date: August 13, 2025 | By: | /s/ Hsin-Liang Lee |
| Hsin-Liang Lee, Chief Financial Officer | ||
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