Ainos, Inc. - Quarter Report: 2021 March (Form 10-Q)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

 

(Mark One)

For the quarterly period ended March 31, 2021

or

For the transition period from____to____ Commission File No. 0-20791

 

AINOS, INC.

(Exact name of registrant as specified in its charter)

TEXAS		75-1974352
(State or other jurisdiction of 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)

AMARILLO BIOSCIENCES, INC.

4134 Business Park Drive, Amarillo, TX 79110-4225

(Former name or former address if changed since last report)

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. D

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) [ ] Yes [√] No

142,240,594 shares of common stock, par value $0.01 per share, outstanding as of May 14, 2021

AINOS, INC.

 

INDEX

 

		PAGE NO.
PART I:	FINANCIAL INFORMATION
ITEM 1.	Financial Statements
	Balance Sheets– March 31, 2021 and December 31, 2020 (unaudited	3
	Statements of Operations – Three Months Ended March 31, 2021 and 2020 (unaudited)	4
	Statements of Stockholders’ Equity (Deficit) – Three Months Ended March 31, 2021 and 2020 (unaudited)	5
	Condensed Statements of Cash Flows – Three Months Ended March 31, 2021 and 2020 (unaudited)	6
	Notes to Financial Statements (unaudited)	7
ITEM 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	12
ITEM 3.	Quantitative and Qualitative Disclosures About Market Risk	19
ITEM 4.	Controls and Procedures	19
PART II:	OTHER INFORMATION
ITEM 1.	Legal Proceedings	20
ITEM 2.	Unregistered Sales of Equity Securities and Use of Proceeds	24
ITEM 3.	Defaults Upon Senior Securities	24
ITEM 4.	Mine Safety Disclosures	24
ITEM 5.	Other Information	24
ITEM 6.	Exhibits	25
Signatures		27

 

 

 

 

 

 

 

PART I - FINANCIAL INFORMATION

Ainos, Inc.

Balance Sheets

(Unaudited)

 

	March 31, 2021	December 31, 2020
Assets
Current assets:
Cash and cash equivalents	$9,377	$22,245
Inventory	-	3,024
Prepaid expense and other current assets	32,890	51,144
Total current assets	42,267	76,413
Patents, net	177,051	180,628
Property and equipment, net	2,921	3,249
Total assets	$222,239	$260,290
Liabilities and Stockholders' Equity (Deficit)
Current liabilities:
Accounts payable and accrued expenses	$348,548	$145,567
Notes payable – related party	236,854	-
Convertible notes payable – related party	915,016	953,001
Total current liabilities	1,500,418	1,098,568
Total liabilities	1,500,418	1,098,568
Stockholders' equity (deficit)
Preferred stock, $0.01 par value:
Authorized shares - 10,000,000,
Issued and outstanding shares – 0 at March 31, 2021 and December 31, 2020	-	-
Common stock, $0.01 par value:
Authorized shares - 100,000,000,
Issued and outstanding shares – 42,066,172 and 42,066,172 at March 31, 2021 and December 31, 2020, respectively	420,662	420,662
Additional paid-in capital	5,055,420	4,961,315
Accumulated deficit	(6,754,261)	(6,220,255)
Total stockholders’ equity (deficit)	(1,278,179)	(838,278)
Total liabilities and stockholders’ equity (deficit)	$222,239	$260,290

 

See accompanying notes to financial statements.

 

Ainos, Inc.

Statements of Operations

(Unaudited)

 

	Three Months Ended March 31,
	2021	2020
Revenues	$2,121	$15,200
Cost of revenues	(1,249)	(10,806)
Gross margin	872	4,394
Operating expenses:
Selling, general and administrative expenses	522,981	380,268
Total operating expenses	522,981	380,268
Operating loss	(522,109)	(375,874)
Other income (expense):
Interest expense, net	(11,897)	(1,005)
Net loss	(534,006)	(376,879)
Less: Net Income attributable to non-controlling interests	-	-
Net loss attributable to common shareholders	$(534,006)	$(376,879)
Basic and diluted net loss per average share available to common shareholders	$(0.01)	$(0.01)
Weighted average common shares outstanding – basic and diluted	42,066,172	40,516,351

 

See accompanying notes to financial statements.

 

 

Ainos, Inc.

Statements of Stockholders’ Equity (Deficit)

For the three months ended March 31, 2021 and 2020

(Unaudited)

 

	Preferred Stock		Common Stock		Additional Paid in	Accumulated	Total Stockholders'
	Shares	Amount	Shares	Amount	Capital	Deficit	Equity (Deficit)
Balance at December 31, 2019	-	$-	40,516,351	$405,164	4,207,786	(4,769,632)	(156,682)
Warrant expense	-	-	-	-	9,496	-	9,496
Option expense	-	-	-	-	90,688	-	90,688
Net loss	-	-	-	-	-	(376,879)	(376,879)
Balance at March 31, 2020	-	$-	40,516,351	$405,164	4, 307,970	(5,146,511)	(433,377)
Balance at December 31, 2020	-	$-	42,066,172	$420,662	4,961,315	(6,220,255)	(838,278)
Warrant expense	-	-	-	-	3,417	-	3,417
Option expense	-	-	-	-	90,688	-	90,688
Net loss	-	-	-	-	-	(534,006)	(534,006)
Balance at March 31, 2021	-	$-	42,066,172	$420,662	5,055,420	(6,754,261)	(1,278,179)

 

See accompanying notes to financial statements.

 

Ainos, Inc.

Condensed Statements of Cash Flows

(Unaudited)

 

	Three months ended March 31,
	2021	2020
Net cash used in operating activities	$(115,712)	$(119,482)
Cash flows from financing activities
Proceeds from related party note	102,844	-
Net cash provided by financing activities	102,844	-
Net change in cash	(12,868)	(119,482)
Cash and cash equivalents at beginning of period	22,245	409,039
Cash and cash equivalents at end of period	9,377	$289,557
Supplemental Cash Flow Information
Cash paid for interest	$-	$-
Cash paid for income taxes	$-	$-
Non-Cash Transactions
Stock issued for accrued liabilities	$-	$-
Stock issued for advances from investors	$-	$-
Conversion of debt to common stock	$-	$-

 

See accompanying notes to financial statements.

Ainos, Inc.

Notes to Financial Statements

(Unaudited)

 

 

 

 

The continuing operations of the Company and the recoverability of the carrying value of assets is dependent upon the ability of the Company to obtain necessary financing to fund its working capital requirements, and upon future profitable operations. The accompanying financial statements do not include any adjustments relative to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result from the outcome of this uncertainty.

 

 

There can be no assurance that capital will be available as necessary to meet the Company's working capital requirements or, if the capital is available, that it will be on terms acceptable to the Company. The issuances of additional equity securities by the Company may result in dilution in the equity interests of its current stockholders. Obtaining commercial loans, assuming those loans would be available, will increase the Company's liabilities and future cash commitments. If the Company is unable to obtain financing in the amounts and on terms deemed acceptable, the business and future success may be adversely affected and the Company may cease operations. These factors raise substantial doubt regarding our ability to continue as a going concern.

 

 

We have not paid any dividends to our common stock shareholders to date, and have no plans to do so in the immediate future.

 

 

Note #.	Conversion Rate	Interest Rate	March 31, 2021	December 31, 2020
Note 1 - Chen	$0.1680	0.75%	$114,026	$114,026
Note 2 - Chen	$0.1875	0.65%	$262,500	$262,500
Note 3.19 - Chen	$0.2500	1.85%	$39,620	$39,620
Note 4.19 - Chen	$0.2500	1.61%	$14,879	$14,879
Note 5.19 – i2China	$0.2500	1.85%	$16,000	$16,000
Note 6.20 - Chen	$0.2500	1.85%	$216,600	$216,600
Note 7.20 - Chen	$0.2500	1.60%	$23,366	$23,366
Note 8.20a – i2China	$0.2500	1.85%	$48,000	$48,000
Note 8.20b – i2China	$0.2500	1.85%	$84,000	$84,000
Note 9.21 - Chen	N/A	0.13%	$236,854	$134,010
Note 10.21 – Chen	$0.2500	1.85%	$59,025	-
Note 11 – i2China	$0.2500	1.85%	$37,000	-
Total Convertible Notes (including accrued Interest) – Related Party			$1,151,870	$953,001

 

Dr. Stephen T. Chen, Chairman, CEO, President, and CFO, and i2China Management Group, LLC, the Company’s management consultant, elected to defer cash compensation during a period of development and fundraising. The parties received convertible promissory notes in consideration of the deferrals.

 

 

On January 1, 2020, the Company issued Note #6.20 for deferred compensation to Dr. Stephen T. Chen, Chairman, CEO, President, and CFO, in the amount of $216,600, the maximum amount of cash compensation that could be deferred for 2020. The Note is payable on January 1, 2021, or on demand and bears interest at the AFR1 short-term rate of 1.85%. The note is an advancing note with a maximum limit of $216,600 whereby the Company promises to repay the aggregate Principal Amount advanced to date up to the stated maximum amount at Maturity.

 

The Company may request and the payee shall advance up to $9,025 on the 15th and last day of each month until the note matures. The Note may be convertible in whole or in part at a conversion price of $0.25 per share into the Company’s common voting stock. All shares issued are to be restricted subject to Rule 144 promulgated under the U.S. Securities Act of 1933. The Company may prepay the Note in whole or in part at any time without penalty.

 

On January 1, 2020, the Company issued Note #7.20 to Dr. Stephen T. Chen for deferred reimbursement of expenses advanced on behalf of the Company for $30,000, the maximum amount of reimbursable expense that could be deferred. Actual reimbursable expenses deferred is $23,366. The Note is payable on January 1, 2021, or on demand and bears interest at the AFR1 short-term rate of 1.60%. The note is an advancing note with a maximum limit of $30,000 whereby the Company promises to repay the aggregate Principal Amount advanced to date up to the stated maximum amount at Maturity. The Company may request and the payee shall advance against the Note, until Maturity, the amount submitted on a completed and approved reimbursement form along with documentation of the amount to be advanced. The Note may be convertible in whole or in part at a conversion price of $0.25 per share into the Companuy’s common voting stock. All shares issued are to be restricted subject to Rule 144 promulgated under the U.S. Securities Act of 1933. The Company may prepay the Note in whole or in part at any time without penalty.

 

On January 1, 2020, the Company issued Note #8.20 for deferred compensation to i2China Management Group, LLC in the amount of $48,000, the maximum amount of cash compensation that could be deferred in 2020. The Note is payable on January 1, 2021, or on demand and bears interest at the AFR1 short-term rate of 1.85%. The note is an advancing note with a maximum limit of $48,000 whereby the Company promises to repay the aggregate Principal Amount advanced to date up to the stated maximum amount at Maturity. The Company may request and the payee shall advance up to $4,000 on the last day of each month until the note matures. The Note may be convertible in whole or in part at a conversion price of $0.25 per share.

 

On January 1, 2021, the Company issued Note #10.21 for deferred compensation to Dr. Stephen T. Chen, Chairman, CEO, President, and CFO, in the amount of $59,025. The Note is payable on April 1, 2021, or on demand and bears interest at the AFR short-term rate of 1.85%. The note is an advancing note with a maximum limit of $59,025 whereby the Company promises to repay the aggregate Principal Amount advanced to date up to the stated maximum amount at Maturity. The Company may request and the payee shall advance up to $9,025 on the 15th and last day of each month until the note matures. The Note may be convertible in whole or in part at a conversion price of $0.25 per share into the Company’s common voting stock.

__________

1 Applicable Federal Rate - the minimum interest rate that the Internal Revenue Service (IRS) allows for private loans. The IRS publishes a monthly set of interest rates that the agency considers the minimum market rate for loans, whereas, interest rates less than the AFR would have tax implications.

 

On January 1, 2021, the Company issued Note #11 for deferred compensation to i2China Management Group, LLC in the amount of $37,000. The Note is payable on April 1, 2021, or on demand and bears interest at the AFR1 short-term rate of 1.85%. The note is an advancing note with a maximum limit of $37,000 whereby the Company promises to repay the aggregate Principal Amount advanced to date up to the stated maximum amount at Maturity. The Company may request and the payee shall advance up to $11,000 on the last day of each month until the note matures. The Note may be convertible in whole or in part at a conversion price of $0.25 per share.

 

The notes are unsecured and are due on demand. All shares issued on conversion are to be restricted subject to Rule 144 promulgated under the U.S. Securities Act of 1933. The Company may prepay the notes in whole or in part at any time without penalty. The convertible notes due to Dr. Chen are related party notes.

 

 

 

On April 1, 2021, the Company issued Note #11.21 for deferred compensation to Dr. Stephen T. Chen, Chairman, CEO, President, and CFO, in the amount of $18,050.  The Note is payable on May 1, 2021, or on demand and bears interest at the AFR[1] short-term rate of 1.85%.  The note is an advancing note with a maximum limit of $18,050 whereby the Company promises to repay the aggregate Principal Amount advanced to date up to the stated maximum amount at Maturity. The Company may request and the payee shall advance up to $9,025 on the 15th and last day of each month until the note matures.  The Note may be convertible in whole or in part at a conversion price of $0.25 per share into the Company’s common voting stock.

On April 15, 2021, the Company consummated its Securities Purchase Agreement dated December 24, 2020 (“Ainos Agreement”) with a strategic investor, Ainos, Inc., a Cayman Islands corporation (“Investor”) focused on advanced technology diagnostic medical devices and artificial intelligence consumer healthcare solutions. Investor develops and manufactures point-of-care testing (“POCT”) rapid test kit products that include diagnostics for COVID-19 (SARS CoV2 Antigen Rapid Test), pneumonia, vaginal infection and helicobacter pylori (H. pylori) bacterial infection. Investor POCT delivers test results rapidly utilizing biosensors and artificial intelligence algorithms for volatile organic compound (VOC) analysis.  Pursuant to the Agreement, the Company issued 100,000,000 shares of common stock at $0.20 per share to Investor in exchange for certain patent assignments, increased its authorized common stock to 300,000,000 shares, and changed the Company’s name to “Ainos, Inc.” The Company’s prior Board of Directors resigned and seven (7) new board members were elected by our shareholders. In connection with the consummation of the transaction, Mr. Chun-Hsien Tsai was appointed to serve as the Company’s Chairman of Board, President, Chief Executive Officer and Chief Financial Officer. Mr. Chia-Hsi Chen was appointed to serve as the Company’s Chief Operating Officer effective as of April 15, 2021 but thereafter resigned effective as of April 28, 2021. Immediately after the consummation of the transaction and the issuance of the shares to the Investor, the Investor ownership in the Company is approximately 70.30% of the issued and outstanding shares of common stock of the Company. The foregoing description of the closing of the Ainos Agreement is not complete and is qualified in its entirety by the Form 8-K filed by the Company with the SEC on April 21, 2021, attached hereto as Exhibit 99.2 and which is incorporated herein by reference.

 

 

On April 27, 2021, the Company issued Note #12.21 for a short-term loan for working capital purposes from Ainos, Inc., a Cayman Islands Corporation in the amount of $15,000.  The Note is payable on October 27, 2021, or on demand and bears interest at the AFR1 short-term rate of 1.85%.  The note has a maximum limit of $15,000 whereby the Company promises to repay the aggregate Principal Amount to date up to the stated maximum amount at Maturity.  The Note may be convertible in whole or in part at a conversion price of $0.20 per share.

 

On April 28, 2021, Mr. Chia-Hsi Chen resigned as the Company’s Chief Operating Officer as of April 28, 2021 as reported by the Form 8-K filed by the Company with the SEC on May 3, 2021, attached hereto as Exhibit 99.3 and which is incorporated by reference.

 

On May 5, 2021, the Company issued Note #13.21 for a short-term loan for working capital purposes from Ainos, Inc., a Cayman Islands Corporation in the amount of $20,000.  The Note is payable on November 5, 2021, or on demand and bears interest at the Applicable Federal Rate (short-term rate) of 1.85%.  The note has a maximum limit of $20,000 whereby the Company promises to repay the aggregate Principal Amount to date up to the stated maximum amount at Maturity.  The Note may be convertible in whole or in part at a conversion price of $0.20 per share.

 

Notes #11.21, #12.21, and #13.21 are un-secured and are due on demand.  All shares issued on conversion are to be restricted subject to Rule 144 promulgated under the U.S. Securities Act of 1933.  The Company may prepay the notes in whole or in part at any time without penalty. The convertible notes due to Dr. Chen and Ainos, Inc., a Cayman Islands Corporation are related party notes.

 

 

 

The following discussion should be read in conjunction with our financial statements and the notes thereto which appear elsewhere in this report. The results shown herein are not necessarily indicative of the results to be expected in any future periods.

 

Overview

 

Ainos, Inc. (the "Company”) is a Texas corporation formed in 1984 engaged in developing biologics for the treatment of human and animal diseases. Our current focus is research aimed at the treatment of human disease indications, particularly influenza, hepatitis C, thrombocytopenia, and other indications using interferon (IFN) alpha that is administered in a proprietary low-dose non-injectable form. In addition to its core technology the Company is working to expand the Company’s current focus into a diversified healthcare business portfolio in order to generate new revenue streams.

 

The Company presently owns eight issued patents with two patents pending. This collection consists of patents with claims that encompass method of use or treatment, and/or composition of matter and manufacturing as well as design utility and/or invention. Of the eight issued patents, four patents are related to the low-dose oral delivery of interferon, one patent is for a product promoting oral health, and three patents are associated with treatment of metabolic disorders.

 

The Company primarily operates three business units: the Medical, Pharmaceutical, and Consumer Product Divisions. Historically, the Company has focused on R&D involving low-dose, orally administered lozenges containing the natural immune system activator interferon-alpha as a treatment for a variety of disease indications. The Company owns a proprietary library of over thirty years of scientific and clinical data on the human and animal applications of low-dose oral interferon. Through the Pharmaceutical Division, the Company seeks to out-license or leverage in other ways its core technology by forming partnerships to develop current and new discoveries and commercialize the resulting products.

 

An integral part of the company’s operating strategy is to create multiple revenue streams through the implementation of programs (including but not limited to in-licensing) of medical and healthcare products and therapeutics. The Medical Division and Consumer Products Division facilitate the enhancement of these revenue streams. These programs will be the catalysts that allow the Company to enter markets in Taiwan, Hong Kong, China, and other Asian countries for the distribution of new medical and healthcare products.

 

Over the past several years the Company has focused its research efforts towards the development of a novel pulsatile insulin pump infusion therapy in Taiwan that consists of delivering insulin intravenously in pulses, as opposed to the typical subcutaneous route of administration, in order to more closely imitate how the pancreas secretes insulin in healthy non-diabetics. The Company plans to offer an innovative and comprehensive diabetes treatment that provides solutions to all stages of diabetes from pre-diabetes through late-stage diabetes with advanced complications. The Company intends to target Taiwan first as an R&D base and demonstration platform in Greater China, and subsequently establish a licensing platform for clinics in Greater China. The Consumer Product Division is presently focused on sales of liposomal nutraceuticals and food supplements that include Vitamin C, Glutathione, CoQ10, Curcumin/Resveratrol, DHA, and a Multi-Vitamin.

 

 

The Company maintains a representative branch office in Taiwan – Amarillo Biosciences, Inc. (the “Taiwan Branch”) to increase the Company's presence in Taiwan and to serve as an operational hub to access growing Asian markets.

 

Injectable high-dose interferon is FDA-approved to treat some neoplastic, viral and autoimmune diseases.  Many patients experience moderate to severe side-effects causing them to discontinue injectable interferon therapy. Our core technology is primarily based on low-dose non-injectable interferon-alpha that is delivered into the oral cavity as a lozenge in low doses. The lozenge dissolves in the mouth where interferon binds to surface (mucosal) cells in the mouth and throat, resulting in activation of hundreds of genes in the peripheral blood that stimulate the immune system.  Human studies have shown that oral interferon is safe and effective against viral and neoplastic diseases. Oral interferon is given in concentrations 10,000 times less than that usually given by injection. The Company’s low-dose formulation results in almost no side effects, in contrast to high dose injectable interferon, which causes adverse effects in at least 50% of recipients.

 

Governmental or FDA approval is required for low-dose oral interferon. We believe that our technology is sound and can be commercialized for various indications. Due to lack of appropriate interferon supply in the market over the past several years, we have been unsuccessful at such commercialization to date. However, as a result of Covid-19, Chinese government health authorities have recommended use of anti-AIDS drugs and interferon. The Company believes this has brought renewed attention in the importance of incorporating low-dose interferon as a treatment to help stem the pandemic. In light of these circumstances, the Company is uniquely positioned to potentially develop safe, low-dose interferon.

 

While the pharmaceutical industry is creating and marketing new and effective anti-viral medications, there still exists opportunities to develop and commercialize low-dose interferon as a safer anti-viral treatment for influenza, hepatitis, and other conditions caused by viruses such as genital warts and canker sores. Interferon also has powerful cytotoxic effects which in combination with its immune stimulating activities could play a role in the rapidly expanding field of cancer immunotherapy. Other demonstrated effects of interferon offer opportunities to commercialize low-dose interferon for the treatment of Thrombocytopenia and chronic cough in lung diseases such as COPD and Idiopathic Pulmonary Fibrosis (IPF). The Company has the opportunity to capitalize on its relationship channels in the Asian markets to explore sources of raw materials, capital, production facilities, and to target a significant and growing sales market.

 

Ainos, Inc. Securities Purchase Agreement

 

On December 24, 2020, the Company entered into a Securities Purchase Agreement (“Ainos Agreement”) with Ainos, Inc., a Cayman Islands corporation (“Purchaser”) and certain principal shareholders of the Company including (i) Stephen T. Chen, individually and as Trustee of the Stephen T. Chen and Virginia M. Chen Living Trust, dated April 12, 2018, (ii) Virginia M. Chen, individually and as Trustee of the Stephen T. Chen and Virginia M. Chen Living Trust, dated April 12, 2018, and (iii) Hung Lan Lee (collectively, “Principal Shareholders”). 

 

 

Pursuant to the Ainos Agreement, upon the closing of the transactions contemplated thereby (the “Closing”), the Company will acquire certain patent assets (the “Patent Assets”) by issuing 100,000,000 shares of common stock (the “Shares”) valued at $0.20 to Purchaser.  The Patent Assets encompass technologies relating to development and manufacturing of point-of-care testing rapid test kit products that include diagnostics for COVID-19 (SARS CoV2 Antigen Rapid Test), pneumonia, vaginal infection and helicobacter pylori (H. pylori) bacterial infection.  The Company anticipates that the Shares issued to the Purchaser will represent approximately 70.30% of the issued and outstanding shares of common stock of the Company and effect a change of control in the Company at the Closing.  The Ainos Agreement provides for certain registration rights to the Purchaser regarding the Shares. 

 

The foregoing description of the Ainos Agreement is not complete and is qualified in its entirety by the text of the agreement, which is included as Exhibit 2.1 to the Form 8-K filed by the Company with the SEC on December 30, 2020, which is incorporated herein by reference.

 

On December 18, 2020, the Company Board, and on January 25, 2021, the holders owning a majority of the shares of common stock of the Company as of the record date of January 22, 2021 approved certain Company actions required under the Ainos Agreement. The Company filed a Form 14-C definitive information statement regarding the majority stockholder approval of the Company actions required for closing the Ainos transaction on March 19, 2021, which is incorporated herein by reference, and completed mailing of the information statements to its shareholders on March 26, 2021. The Company expects the Closing to occur on or after April 15, 2021, subject to the terms and conditions of the Ainos Agreement.

 

Patents and Proprietary Rights

 

Since inception, the Company has worked to build an extensive patent portfolio for low-dose orally administered interferon. This portfolio consists of patents with claims that encompass method of use or treatment, and/or composition of matter and manufacturing. As listed below, the Company presently owns eight issued patents with two patents pending.

 

ACTIVE PATENTS:

 

"TREATMENT OF THROMBOCYTOPENIA USING ORALLY ADMINISTERED INTERFERON" as described and claimed in U.S. Patent No. 9,526,694 B2 issued December 27, 2016, Owned. Expiration: April 2033.

 

“TREATMENT OF THROMBOCYTOPENIA USING ORALLY ADMINISTERED INTERFERON" as described and claimed in U.S. Patent No. 9,750,786 B2 issued September 5, 2017, Owned. Expiration: April 2033.

 

“TREATMENT OF THROMBOCYTOPENIA USING ORALLY ADMINISTERED INTERFERON" as described and claimed in U.S. Patent No. 9,839,672 B2 issued December 12, 2017, Owned. Expiration: April 2033.

 

"TREATMENT OF THROMBOCYTOPENIA USING ORALLY ADMINISTERED INTERFERON" as described and claimed in TAIWAN Patent No. I592165 issued July 21, 2017, Owned. Expiration: May 2033.

 

 

"COMPOSITION AND METHOD FOR PROMOTING ORAL HEALTH" as described and claimed in U.S. Patent No. 6,656,920 B2 issued December 2003, Owned. Expiration: April 2021.

 

“SMART DRUG INJECTION DEVICE” as described and claimed in TAIWAN invention patent application number 108137797, Owned, Issued: November 27, 2020, Expiration: October 18, 2039

 

“SMART DRUG INJECTION DEVICE” as described and claimed in TAIWAN design utility model patent application number 108213819, Owned, Issued: December 12, 2019, Expiration: November 11, 2038.

 

“SMART DRUG INJECTION DEVICE” as described and claimed in CHINA design utility model patent application number 201921808292.6, Owned, Issued: July 28, 2020, Expiration: June 27, 2039.

 

“SMART DRUG INJECTION DEVICE” as described and claimed in CHINA invention patent application number 201911024619.5, Pending.

 

“SMART DRUG INJECTION DEVICE” as described and claimed in US invention patent application number 17/069,418, Pending.

 

There are no current patent litigation proceedings involving the Company.

 

Cost of Compliance with Environmental Regulations

 

The Company incurred no costs to comply with environment regulations during the timeframe of this report.

 

United States Regulation

 

Before products with health claims can be marketed in the United States, they must receive approval from the U.S. Food and Drug Administration (“FDA”). To receive this approval, any drug must undergo rigorous preclinical testing and clinical trials that demonstrate the product candidate’s safety and effectiveness for each indicated use. This extensive regulatory process controls, among other things, the development, testing, manufacture, safety, efficacy, record keeping, labeling, storage, approval, advertising, promotion, sale, and distribution of pharmaceutical products.

 

In general, before any ethical pharmaceutical product can be marketed in the United States, the FDA will require the following process:

 

●	Preclinical laboratory and animal tests;
●	Submission of an investigational new drug application, or IND, which must become effective before human clinical trials may begin;
●	Adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug for its intended use;
●	Pre-approval inspection of manufacturing facilities and selected clinical investigators;
●	Submission of a New Drug Application (NDA) to the FDA; and
●	FDA approval of an NDA, or of an NDA supplement (for subsequent indications or other modifications, including a change in location of the manufacturing facility).

 

 

Substantial financial resources are necessary to fund the research, clinical trials, and related activities necessary to satisfy FDA requirements or similar requirements of state, local, and foreign regulatory agencies. At such time as the Company undertakes to commercialize any of its products, all necessary preclinical testing, clinical trials, data review, and approval steps will be judiciously executed to insure that the product satisfies all regulatory requirements at all levels.

 

505(b)(2)

 

The Company has historically followed and will continue to follow the traditional approval process for New Drugs as set out in Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act. If an alternative path to FDA approval for new or improved formulations of previously approved products is scientifically and economically feasible and beneficial to the Company and the public, the Company may choose to follow this alternative path as established by section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. This section of the Act permits the applicant to rely on certain preclinical or clinical studies conducted for an approved product as some of the information required for approval and for which the applicant has not obtained a right of reference. The process of approval under 505(b)(2) will be followed as judiciously as 505(b)(1) or any regulation.

 

Orphan Drug Designation

 

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States. The Company may choose to seek approval for a product satisfying the definition of an Orphan Drug if that product can be used to treat such an indication. Orphan drug designation does not convey any advantage in or shorten the duration or rigidity of the regulatory review and approval process.

 

Similarly, substantial financial resources are necessary to fund the research, design, testing, fabrication and related activities necessary to satisfy FDA requirements or similar requirements of state, local, and foreign regulatory agencies for medical devices. The Company may seek to obtain FDA clearance for the sales, marketing, and use of its novel pulsatile insulin pump for the U.S. market after obtaining FDA approvals under one of the following regulatory approvals:

 

Premarket Notification 510(k) 

 

Each person who intends to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (“PMA”) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).

 

If the Company’s novel pulsatile insulin pump is determined to be similar to one already cleared for the U.S. market, the Company will seek FDA clearance under 510(k) at least 90 days before the device is marketed. A 510(k) application requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. Documented laboratory testing among other submissions will be required and if the Company’s device features significant alterations from predecessor devices the Company may be required to present results from clinical trials.

 

 

Premarket Approval (PMA)

 

Alternatively, if the Company’s device is deemed to be completely new to the U.S. market or classified as a Class III device, the Company will be required to apply for PMA approval. The Medical Device Amendments of 1976 to the FD&C Act established three regulatory classes for medical devices. The three classes are based on the degree of control necessary to assure that the various types of devices are safe and effective. The most regulated devices are in Class III. The amendments define a Class III device as one that supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury. 

 

Under Section 515 of the FD&C Act, all devices placed into Class III are subject to premarket approval requirements. Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices.

 

Foreign Regulation

 

In addition to regulations in the United States, a variety of foreign regulations govern clinical trials and commercial sales and distribution of products in foreign countries. Whether or not the Company obtains FDA approval for a product, the Company must obtain approval of a product by the comparable regulatory authorities of foreign countries before the Company can commence clinical trials or market the product in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.

 

The policies of the FDA and foreign regulatory authorities may change and additional government regulations may be enacted which could prevent or delay regulatory approval of investigational drugs or approval of new diseases for existing products and could also increase the cost of regulatory compliance. It is not possible to predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the United States or abroad.

 

Research and Development

 

During the quarter ended March 31, 2021 and the first quarter of 2020, the Company did not incur research and development expenses.

 

Employees

 

The Company currently has two full-time employees and two part-time employees. Of these four employees, two are executive officers and two work in administrative capacities.

 

Stephen T. Chen: Chairman, Chief Executive Officer (CEO), President and Chief Operating Officer (COO), and Chief Financial Officer (CFO). Dr. Chen was named Chairman of the Board in February 2012, and he has been a director of the Company since February 1996. He currently executes the management functions as not only Chairman, but as CEO, President, COO, and CFO.

 

 

Bernard Cohen: Vice President - Administration (VP-Admin). Mr. Cohen holds BBA and MPA degrees from West Texas A&M University. He is a long time Amarillo resident with over thirty years of management experience. Mr. Cohen has been with the Company since October 2009. Mr. Cohen works with Ms. Shelton, providing the reporting necessary for the Company’s various SEC filings, and ordinary-course internal bookkeeping and accounting services.

 

Chrystal Shelton: Office Manager & Administration. Ms. Shelton has been with the Company since 1987. In addition to handling routine office administration, Ms. Shelton is responsible for accounting, form, and formatting of SEC filings. She is an integral part of the reporting process and interacts with outside professionals who assist the Company in its various compliance measures.

 

Maggie Wang: Director of Business Development. Ms. Wang has an extensive background in business development and marketing of consumer products in Asian countries. Ms. Wang is also the branch manager for the Taiwan Branch.

 

Consultants

 

From time to time, the Company engages consultants as needed for specific areas of responsibility. Presently, the Company has engaged the following consultants: John Junyong Lee, Esq. - Chief Legal Counsel and Corporate Secretary, Dr. Yung-Hsiang Hung - Director-Medical Division; and i2China Management Group, LLC (Mr. Lawrence Lin)- Executive Advisor.

 

Results of Operations for Quarter Ended March 31, 2021 and 2020:

 

Revenues. The Company reported revenue for the quarter ended March 31, 2021, of $2,121 from sales of liposomal nutraceuticals. Revenue for the same period in 2020 was $15,200 also from sales of nutraceuticals. The cost of sales for the first quarter of 2021 was $1,249 as compared to $10,806 for cost of sales in 2020. Gross profit for the quarter in 2021 was $872 as compared to $4,394 in 2020, a decrease of $3,522.

 

Research and Development Expenses. There was no R&D activity in this quarter of 2021 or 2020.

 

Selling, General and Administrative Expenses. Selling, general and administrative expenses were $142,713 (38%) higher in 2021 than 2020 largely due to increased expenses associated with the Securities Purchase Agreement transaction with Ainos Inc.

 

Operating Loss. The Company's operating loss was $522,109 which was $146,235 (39%) higher for 2021 than 2020 mostly due to the expense of the Securities Purchase Agreement transaction with Ainos Inc.

 

Interest Expense. During the three months ended March 31, 2021, interest expense, net was $11,897, compared to $1,005 for the three months ended March 31, 2020. The interest expense recognized in the three months ended March 31, 2021 is mostly due to accrued interest for convertible debt notes.

 

Net Loss. Net loss attributable to common shareholders was $534,006 which was $157,127 (42%) higher during 2021 than 2020. This increase was mainly due to expenses related to processing of our Securities Purchase Agreement with Ainos Inc. in 2021.

 

 

Liquidity and Capital Resources

 

As of March 31, 2021, the Company had available cash of $9,377 whereas it had a cash position of $289,557 for the same period in 2020 and $22,245 as of December 31, 2020. The Company had a working capital deficit of $1,458,151 at the end of March 2021, and a working capital deficit of $580,993 for the same period in 2020, an increase of 151%. As of December 31, 2020, working capital was a deficit of $1,022,155. The average monthly burn rate in 2020 was $65,000. Going forward, we expect that the burn rate will continue to be in that same range.

 

The Company continues to develop and establish new revenue streams to become, and maintain, the position of a profitable going concern. Two major areas of focus are (1) to continue to leverage the Company’s core technology, the development and application of low-dose oral interferon, and (2) to commercialize its metabolic restoration therapy for the treatment of diabetes and other metabolic diseases. The Company aggressively seeks to monetize its existing intellectual property as well as potential new discoveries and estimates its short-term project development needs to be between $3,000,000 and $6,000,000 depending upon project negotiated terms and structuring yet to be determined.

 

There can be no assurance that we will be successful in our efforts to make the Company profitable. If those efforts are not successful, we will be forced to cease operations.

 

 

As a “smaller reporting company,” we are not required to provide the information under this Item 3.

 

Disclosure Controls and Procedures

 

At the end of the period covered by this report, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2021. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of March 31, 2021, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

 

 

Management's Report on Internal Control Over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation under the framework in Internal Control - Integrated Framework (2013), our management concluded that our internal control over financial reporting was effective at the reasonable assurance level as of March 31, 2021.

 

Changes in Internal Control Over Financial Reporting

 

We have not experienced any material impact to our internal controls over financial reporting even though our workforce continues to primarily work-from-home due to COVID-19. We are continually monitoring and assessing the COVID-19 situation and its impact on our internal controls.

 

This interim report does not include an attestation report of the Company’s independent registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our independent registered public accounting firm pursuant to temporary rules of the SEC that permit the company to provide only management's report in this interim report.

 

 

PART II - OTHER INFORMATION

 

 

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 such legal proceedings or claims against us.

 

 

Please carefully consider the following discussion of significant factors, events, and uncertainties that make an investment in our securities risky. The events and consequences discussed in these risk factors could, in circumstances we may or may not be able to accurately predict, recognize, or control, have a material adverse effect on our business, growth, reputation, prospects, financial condition, operating results (including components of our financial results), cash flows, liquidity, and stock price. These risk factors do not identify all risks that we face; our operations could also be affected by factors, events, or uncertainties that are not presently known to us or that we currently do not consider to present significant risks to our operations. In addition, the global economic climate amplifies many of these risks.

 

 

We Face Intense Competition

 

The pharmaceutical industry is an expanding and rapidly changing industry characterized by intense competition. The Company believes that our ability to compete will be dependent in large part upon our ability to successfully operate business lines, continue recapitalization, and steadily enhance and improve our core technology products. In order to do so, we must effectively utilize and expand our research and development capabilities and, once developed, quickly convert new technology into products and processes, which can then be commercialized. Competition is based primarily on scientific and technological superiority, technical support, availability of patent protection, access to adequate capital, the ability to develop, acquire and market products and processes successfully, the ability to obtain governmental approvals and the ability to serve the particular needs of commercial customers. Corporations and institutions with greater resources therefore, have a significant competitive advantage.

 

Our potential competitors include entities that develop and produce therapeutic agents and/or medical devices for treatment of human and animal disease. These include numerous public and private academic and research organizations and pharmaceutical and biotechnology companies pursuing production of, among other things, biologics from cell cultures, genetically engineered drugs and natural and chemically synthesized drugs. Many of these potential competitors have substantially greater capital resources, research and development capabilities, manufacturing and marketing resources. Competitors may succeed in developing products or processes that are more effective or less costly or that gain regulatory approval prior to our products. The Company expects that the number of competitors and potential competitors will increase as more anti-viral and cytotoxic products receive commercial marketing approvals from the FDA or analogous foreign regulatory agencies. Any of these competitors may be more successful in manufacturing, marketing and distributing its products.

 

Our Expansion Places a Significant Strain on our Management, Operational, Financial, and Other Resources

 

Increasing our product and service offerings will require scaling our management, financial and research and development resources. The complexity of the current focus of our business on innovative biotechnologies and treatments can place significant strain on our management, personnel, operations, systems, technical performance, financial resources, and internal financial control and reporting functions, and our expansion increases these factors. Failure to manage growth effectively could damage our reputation, limit our growth, and negatively affect our operating results.

 

Our Expansion into New Products, Services, Technologies, and Geographic Regions Subjects Us to Additional Risks

 

We may have limited or no experience in our newer market segments, and our customers may not adopt our product or service offerings. These offerings, which can present new and difficult technology challenges, may subject us to claims if customers of these offerings experience service disruptions or failures or other quality issues. In addition, profitability, if any, in our newer activities may not meet our expectations, and we may not be successful enough in these newer activities to recoup our investments in them. Failure to realize the benefits of amounts we invest in new technologies, products, or services could result in the value of those investments being written down or written off.

 

 

Our International Operations Expose Us to a Number of Risks

 

We have relatively little operating experience and may not benefit from any first-to-market advantages or otherwise succeed. It is costly to establish, develop, and maintain international operations, sales and marketing channels, and research and development and licensing capacity. Our international operations may not become profitable on a sustained basis.

 

In addition to risks described elsewhere in this section, our international sales and operations are subject to a number of risks, including:

 

 

 

 

 

 

 

 

 

Our Commercial Agreements, Strategic Alliances, and Other Business Relationships Expose Us to Risks

 

Our business growth depends on commercial agreements, strategic alliances, and business relationships. Under these agreements, we provide access to our research library and clinical data as part of licensing and sales and marketing agreements. These arrangements are complex and require substantial infrastructure capacity, personnel, and other resource commitments, which may limit the amount of business we can service. We may not be able to implement, maintain, and develop the components of these commercial relationships, which may include research and development, clinical trials, diagnostic software and hardware design, and engaging third parties to perform services.

 

 

Our licensing agreements partially dependent on the volume of the other company’s sales. Therefore, when the other company’s offerings are not successful, the compensation we receive may be lower than expected or the agreement may be terminated. Moreover, we may not be able to enter into additional or alternative commercial relationships and strategic alliances on favorable terms. We also may be subject to claims from businesses to which we provide these services if we are unsuccessful in implementing, maintaining, or developing these services.

 

We Face Significant Supply Risk

 

We are exposed to significant supply risks that may adversely affect our operating results. The Company’s long-time human interferon producer is no longer manufacturing interferon. Plans for further clinical trials and commercialization of a low-dose interferon product have been placed on hold until a new source of interferon is found. The Company is actively seeking a new manufacturing partner and exploring sourcing options with pharmaceutical companies that have a supply of either recombinant interferon or natural human interferon made in a similar manner, but from a different cell line as our previous product.

 

Procuring a new source of interferon may require additional studies to compare results to the Company’s research and further clinical trials will have to be performed. The Company’s inability to secure interferon supplies may adversely affect our operating results.

 

Government Regulation Is Evolving and Unfavorable Changes Could Harm Our Business

 

We are subject to general business regulations and laws, as well as regulations and laws specifically governing biologics, pharmaceuticals, and medical devices and treatments. A large number of jurisdictions regulate our operations, and the extent, nature, and scope of such regulations is evolving and expanding as the scope of our businesses expand. We are regularly subject to formal and informal reviews and investigations by governments and regulatory authorities under existing laws, regulations, or interpretations or pursuing new and novel approaches to regulate our operations. Unfavorable regulations, laws, decisions, or interpretations by government or regulatory authorities applying those laws and regulations, or inquiries, investigations, or enforcement actions threatened or initiated by them, could cause us to incur substantial costs, expose us to unanticipated civil and criminal liability or penalties (including substantial monetary fines), diminish the demand for, or availability of, our products and services, increase our cost of doing business, require us to change our business practices in a manner materially adverse to our business, damage our reputation, impede our growth, or otherwise have a material effect on our operations.

 

Claims, Litigation, Government Investigations, and Other Proceedings May Adversely Affect Our Business and Results of Operations

 

As a company focusing on diagnostics and treatments for a wide range of human health care needs, we may be subject to actual and threatened claims, litigation, reviews, investigations, and other proceedings, including proceedings by governments and regulatory authorities, involving a wide range of issues, including patent and other intellectual property matters, taxes, labor and employment, competition and antitrust, privacy and data protection, product liability, consumer protection, commercial disputes, goods and services offered by us and by third parties, and other matters. Any of these types of proceedings can have an adverse effect on us because of legal costs, disruption of our operations, diversion of management resources, negative publicity, and other factors. The outcomes of these matters are inherently unpredictable and subject to significant uncertainties. 

 

 

 

The 2020-1 Private Placement Equity Security Offering was unanimously authorized and approved by Consent of the Company’s Board of Directors. The Company offered up to 5,208,334 shares of Common voting stock at a price of $0.192 per share for an aggregate amount of $1,000,000. That offering is currently open and still available for investment.

 

On July 28, 2020, Dr. Stephen T. Chen, Chairman, CEO, President, and CFO, executed and submitted a Private Placement Memorandum for the purchase of 520,833 common voting shares at $0.192 per share through the Company’s 2020-1 Private Placement Stock Offering. The total amount of the investment subscription was $100,000 of which $85,000 was tendered to the Company by Dr. Chen subject to his payment of the balance of the subscription. Subsequently, the Company and Dr. Chen rescinded the subscription, the Company retained $85,000 previously tendered as an investment, and the Company included the foregoing amount in an open ended, non-convertible promissory note #9.21 as indicated item 6 (Convertible Notes Payable – Related Parties) in the Notes to Financial Statements.

 

 

None

 

 

Not applicable

 

 

On March 31, 2021, the Company entered into Amendment No. 2 to an Employment Agreement dated December 30, 2020 and effective January 1, 2021 between the Company and Stephen T. Chen (“Chen Agreement”) that extended the agreement to the closing date of the Ainos Agreement and transaction, a copy of which is provided as Exhibit 10.1(l) in this report. The Chen Agreement was reported in the Company’s 10-K report filed with the SEC on March 30, 2021, and is incorporated by this reference.

 

On March 31, 2021, the Company entered into Amendment No. 1 to an Employment Agreement dated December 30, 2020 and effective January 1, 2021 between the Company and Bernard Cohen (“Cohen Agreement”) that extended the agreement to April 5, 2021, a copy of which is provided as Exhibit 10.1(m) in this report. The Cohen Agreement was reported in the Company’s 10-K report filed with the SEC on March 30, 2021, and is incorporated by this reference.

 

 

 

EXHIBIT INDEX

 

			INCORPORATED BY REFERENCE
EXHIBIT NUMBER	DESCRIPTION	FILED WITH THIS FORM 10-K	FILING DATE WITH SEC	FORM	EXH #	HYPERLINK TO FILINGS
3.1(a)	Restated Certificate of Formation of the Company, dated and filed July 27, 2015		3/30/2016	10-K	3.i.	Restated Certificate of Formation of the Company, dated and filed July 27, 2015.
3.1(b)	Bylaws of the Company, as amended July 10, 2015		3/30/2016	10-K	3.ii.	Bylaws of the Company, as amended July 10, 2015.
4.1(a)	Specimen Common Stock Certificate		8/8/1996	SB-2	4.1	Specimen Common Stock Certificate.
4.1(b)	Form of Underwriter’s Warrant		8/8/1996	SB-2	4.2	Form of Underwriter’s Warrant.
10.1(a)	2008 Stock Incentive Plan dated May 20, 2008		5/22/2008	S-8	10.1(11)	2008 Stock Incentive Plan dated May 20, 2008.
10.1(b)	2018 Employee Stock Option Plan		4/16/2019	10-K	10.72	2018 Employee Stock Option Plan
10.1(c)	2018 Officer, Directors, Employees and Consultants Nonqualified Stock Option Plan		4/16/2019	10-K	10.73	2018 Officer, Directors, Employees and Consultants Nonqualified Stock Option Plan
10.1(c)	2018 Stock Option Agreement – Nonqualified Stock Option		4/16/2019	10-K	10.74	Stock Option Agreement – Nonqualified Stock Option
10.1(e)	2018 Stock Option Agreement – Employee Plan		4/16/2019	10-K	10.75	Stock Option Agreement – Employee Plan
10.1(f)*	Employment Agreement between Company and Stephen T. Chen, Ph.D. dated 12/31/20 and effective 01/01/21		3/30/2021	10-K	10.1(f)	https://www.sec.gov/Archives/edgar/data/1014763/000165495421003517/amar_ex101f.htm
10.1(g)*	Amendment No. 1 to Employment Agreement between Company and Stephen T. Chen, Ph.D. effective 01/01/21		3/30/2021	10-K	10.1(g)	https://www.sec.gov/Archives/edgar/data/1014763/000165495421003517/amar_101g.htm
10.1(h)*	Employment Agreement between Company and Bernard Cohen dated 12/31/20 and effective 01/01/21		3/30/2021	10-K	10.1(h)	https://www.sec.gov/Archives/edgar/data/1014763/000165495421003517/amar_ex101h.htm
10.1(i)	Settlement Agreement and Mutual General Release, effective 12/24/20		3/30/2021	10-K	10.1(i)	https://www.sec.gov/Archives/edgar/data/1014763/000165495421003517/amar_ex101i.htm
10.1(j)*	Extension of the consulting agreement and pre-existing warrant certificate between the Company and i2China Management Group, LLC (originally dated April 15, 2018), dated November 30, 2020		3/30/2021	10-K	10.1(j)	https://www.sec.gov/Archives/edgar/data/1014763/000165495421003517/amar_ex101j.htm

 

 

10.1(k)	Securities Purchase Agreement between Company and Ainos, Inc., dated December 24, 2020		12/30/2020	8-K	2.1	https://www.sec.gov/Archives/edgar/data/1014763/000165495420014016/amar_ex2-1.htm
10.1(l)	Amendment No. 2 to Employment Agreement between Company and Stephen T. Chen, Ph.D. dated March 31, 2021	X
10.1(m)	Amendment No. 1 to Employment Agreement between Company and Bernard Cohen dated March 31, 2021	X
13	Form 10-K for period ending December 31, 2020		3/30/2021	10-K		https://www.sec.gov/Archives/edgar/data/1014763/000165495421003517/amar_10k.htm
31.1	Certification of Chief Executive Officer (Principal Executive Officer) required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.	X
32.1	Certification of Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to 18 U.S.C. Section 1350 Section 906 of the Sarbanes-Oxley Act of 2002.	X
99.1	906 Certification	X
99.2	Form 8-K reporting on the closing of the Ainos Agreement and transaction		4/21/2021	8-K		https://www.sec.gov/Archives/edgar/data/1014763/000165495421004461/0001654954-21-004461-index.htm
99.3	Form 8-K reporting on the resignation of the Company’s Chief Operating Officer		5/3/21	8-K		https://www.sec.gov/Archives/edgar/data/1014763/000165495421005015/0001654954-21-005015-index.htm
101.INS	XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the XBRL document.	X
101.SCH	XBRL Taxonomy Extension Schema Document	X
101.CAL	XBRL Taxonomy Extension Calculation Linkbase	X
101.DEF	XBRL Taxonomy Extension Definition Linkbase	X
101.LAB	XBRL Taxonomy Extension Label Linkbase	X
101.PRE	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.

 

+ Schedules (as similar attachments) have been omitted from this filing pursuant to Item 601(a)(5) of Regulation S-K.

 

* Indicates a management contract or compensatory plan or arrangement.

 

 

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: May 14, 2021	By:	/s/ Chun-Hsien Tsai
		Chun-Hsien Tsai, Chairman of the Board,
		Chief Executive Officer and Chief Financial Officer