AIMDW Ainos Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 13, 2024

 

 

AINOS, INC.

(Exact name of registrant as specified in its charter)

 

Texas		001-41461		75-1974352
(State or other Jurisdiction of Incorporation)		(Commission File Number)		(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)

 

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

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

	☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
	☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
	☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
	☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.01 per share		AIMD		The Nasdaq Stock Market LLC
Warrants to purchase Common Stock		AIMDW		The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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. ☐

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On May 13, 2024, Ainos, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2024. A copy of the press release is furnished herewith as Exhibit 99.1 and incorporated herein by reference.

 

The information in this Item 2.02 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any Company filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statement and Exhibits

 

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release dated May 13, 2024, issued by the Ainos, Inc.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	Ainos, Inc.
Date: May 13, 2024	By:	/s/ Chun-Hsien Tsai
		Name: Chun-Hsien Tsai
		Title: Chief Executive Officer

 

 

 

Exhibit 99.1

 

Ainos Reports First Quarter 2024 Financial Results

 

Strategic focus on VELDONA and AI-powered point-of-care testing continues during 2024

 

US$9M growth capital secured in May strengthens financial position for executing growth strategy

 

SAN DIEGO, May 13, 2024 /Accesswire/ — Ainos, Inc. (NASDAQ: AIMD, AIMDW) (“Ainos”, or the “Company”), a diversified healthcare company focused on the development of novel point-of-care testing (“POCT”), low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced its financial results for the first quarter ended March 31, 2024.

 

Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented, “In the first quarter, we successfully completed our strategic pivot away from COVID-19 rapid test kits, which contributed to the management of COVID-19 infections in Taiwan. While this adjustment impacted our near-term revenues, we’ve nonetheless made significant progress in diversifying our business for long-term sustainability. “

 

“Our strategic focus revolves around our AI Nose and VELDONA technologies. Specifically, we will intelligently advance our proprietary AI Nose technology platform-powered POCT candidate, Ainos Flora, and co-develop an innovative volatile organic compounds (“VOC”) sensing platform with our Japanese partners. The co-development program can expand the potential application of our AI-powered VOC sensing technology to telehealth, automotive, industrial, and environmental safety. Our first project aims to improve the quality of elderly care through an innovative AI-driven telehealth-based monitoring solution. We are also exploring to deploy VOC sensing to enable a safer work environment and better production quality in the high-tech factories.”

 

“In addition, we’re moving forward with clinical studies and actively exploring out-licensing opportunities for our VELDONA® human drug candidates. These include our promising candidate for treating oral warts in HIV-positive patients, which has received Orphan Drug Designation from the United States Food and Drug Administration (the “U.S. FDA”), and we plan to prioritize the HIV oral wart and Sjögren’s syndrome programs within our pipeline. Following our successful entry into the petcare market with VELDONA Pet supplement, we are investing to expand into the animal drug category.”

 

“I am confident that our long-term, diversified strategy positions us to deliver sustainable shareholder value. I am also profoundly grateful for the unwavering support from our shareholders. Their assistance was invaluable across multiple aspects, the engine that significantly drove us forward in both our clinical endeavors in Taiwan and collaboration in Japan. We look forward to our product making a swift and positive impact on people.”

 

Christopher Lee, Chief Financial Officer of Ainos, commented, “We have strengthened our financial position with two additional financings. I’m thrilled to share that we have secured a US$9 million convertible note financing convertible at US$4.5 per share, which follows an up to US$1.75 million financing we announced in January. These two financings bolster our position as we continue executing our growth strategy.”

 

 

First Quarter 2024 Financial Results

 

Revenues

 

Revenues were US$20,729 in the first quarter of 2024, compared to US$49,164 in the same period of 2023, reflecting the Company’s cessation of sales of its COVID-19 antigen rapid test kits during the first quarter of 2024 after a strategic pivot shift.

 

Cost of Revenues

 

Cost of revenues was US$26,754 in the first quarter of 2024, compared with U$100,848 in the same period of 2023. The decrease was primarily attributable to a decline in sales volume.

 

Gross Profit

 

In the first quarter of 2024, gross profit was negative US$6,025, significantly narrowing from negative US$51,684 a year ago, due to lower sales volumes of the Company’s newly launched products.

 

Total Operating Expenses

 

Total operating expenses were US$3,114,066 in the first quarter of 2024, compared to US$2,461,348 in the same period of 2023. The change was mainly attributable to increased expenses associated with clinical trial fees, co-research for technology, product and staffing expenditures, and increases in share-based compensation and professional expenses.

 

Operating expenses excluding depreciation and amortization expenses and share-based compensation were US$1,491,770 in the first quarter of 2024, compared to US$1,059,894 in the first quarter of 2023.

 

	●	R&D expenses increased to US$2,084,648 in the first quarter of 2024 from US$1,698,883 in the same period of 2023. Share-based compensation expenses and depreciation and amortization expenses in the first quarter of 2024 were US$1,284,343, compared with US$1,194,984 a year ago. When excluding these non-cash expenses, R&D expenses increased to US$800,305 from US$503,899 over the same period.
	●	SG&A expenses increased to US$1,029,418 from US$762,465 in the same period of 2023. Share-based compensation expenses and depreciation and amortization expenses in the first quarters of 2024 and 2023 were US$337,953 and US$206,470, respectively. When excluding these non-cash expenses, SG&A expenses increased to US$691,465 from US$555,995 over the same period.

 

Net Loss

 

Net loss attributable to common stock shareholders was US$3,314,810 in the first quarter of 2024, compared with US$2,520,475 in the same period of 2023.

 

Balance Sheet

 

As of March 31, 2024, the Company had cash and cash equivalents of US$1,030,899 compared with US$1,885,628 as of December 31, 2023.

 

 

Recent Business Developments

 

On May 6, 2024, the Company announced that it has raised US$9 million of growth capital through a convertible note financing with an existing shareholder. The three-year note carries 6% compound interest and is convertible Company’s common stock at US$4.50 per share. The investor will also receive a warrant to purchase up to 500,000 shares of the Company’s common stock at a price of US$4.50 per share.

 

On January 24, 2024, the Company announced that it had placed an additional financing of up to US$1.75 million. US$875,000 was funded at closing, with the remaining US$875,000 subject to conditions specified in the agreement.

 

On February 5, 2024, the Company announced that it had submitted the clinical hold complete response to the U.S. FDA for conducting a Phase II trial of its low-dose oral interferon (IFN)-alpha formulation, VELDONA®, for treatment of mild COVID-19 symptoms. If approved, the Company’s Phase II trial is expected to involve a multicenter, parallel, randomized study conducted in Taiwan to evaluate the efficacy of VELDONA® in subjects with mild COVID-19 symptoms during the third quarter of 2024.

 

About Ainos, Inc.

 

Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on the development of novel point-of-care testing (POCT), low-dose VELDONA® interferon therapeutics, and synthetic RNA-driven preventative medicine. The company’s products include VELDONA® clinical-stage human therapeutics, VELDONA® Pet cytoprotein health supplements, and telehealth-friendly POCTs powered by its AI Nose technology platform. The lead POCT candidate, Ainos Flora, is intended to be a telehealth-friendly POCT for women’s health and certain common STIs. To learn more, visit https://www.ainos.com.

 

Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date.

 

Safe Harbor Statement

 

This press release contains “forward-looking statements” about Ainos within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “anticipate,” “believe,” “estimate,” “approximate,” “expect,” “intend,” “plan,” “predict,” “project,” “target,” “future,” “likely,” “strategy,” “foresee,” “may,” “guidance,” “potential,” “outlook,” “forecast,” “should,” “will” or other similar words or phrases. Similarly, statements that describe the Company’s objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company’s current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. The Company’s actual results may differ materially from those indicated in the forward-looking statements.

 

 

Important factors that could cause the Company’s actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the products announced in this press release; the Company’s dependence on projected revenues from the sale of current or future products ; the Company’s limited cash and history of losses; the Company’s ability to achieve profitability; the Company’s ability to raise additional capital to continue the Company’s product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos’ current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos’ product candidates; delays in completing the development and commercialization of the Company’s current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company’s industry that may outpace its technology; customer demand for the products and services the Company develops; the accuracy of third-party market research data, the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company’s operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company’s ability to realize the benefits of third party licensing agreements; the Company’s ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market; and the Company’s success in managing growth. A more complete description of these risk factors and others is included in the “Risk Factors” section of Ainos’ Annual Report on Form 10-K for the year ended December 31, 2023 and other reports filed with the U.S. Securities and Exchange Commission (“SEC”), many of which risks are beyond the Company’s control. In addition to the risks described above and in the Company’s reports filed with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release.

 

The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Any forward-looking statements contained in this press release represent Ainos’ views only as of today and should not be relied upon as representing its views as of any subsequent date. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law.

 

Investor Relations Contact

 

Feifei Shen

IR@ainos.com

 

 

Ainos, Inc.

Condensed Balance Sheets

(Unaudited)

 

		March 31,				December 31,
		2024				2023
Assets
Current assets:
Cash and cash equivalents		$	1,030,899			$	1,885,628
Accounts receivable			4,172				455
Inventory, net			169,655				167,593
Other current asset			304,608				419,521
Total current assets			1,509,334				2,473,197
Intangible assets, net			27,155,594				28,283,208
Property and equipment, net			768,665				876,572
Other assets			320,867				208,827
Total assets		$	29,754,460			$	31,841,804
Liabilities and Stockholders’ Equity
Current liabilities:
Contract liabilities		$	108,000			$	112,555
Convertible notes payable			3,000,000				-
Other notes payable, related party			312,000				42,000
Accrued expenses and others current liabilities			1,285,973				1,182,283
Total current liabilities			4,705,973				1,336,838
Senior secured convertible notes measured at fair value			2,369,694				2,651,556
Convertible notes payable - noncurrent			-				3,000,000
Other notes payable, related party - noncurrent			-				270,000
Other long-term liabilities			-				135,829
Total liabilities			7,075,667				7,394,223
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.01 par value; 50,000,000 shares authorized; none issued and outstanding			-				-
Common stock, $0.01 par value; 300,000,000 shares authorized as of March 31, 2024 and December 31, 2023, 6,144,506 and 4,677,787 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively			61,445				46,778
Common stock to be issued, 270 shares and 162,337 shares as of March 31, 2024 and December 31, 2023, respectively			3				1,623
Additional paid-in capital			64,154,052				62,555,808
Accumulated deficit			(41,200,965	)			(37,886,155	)
Accumulated other comprehensive loss - translation adjustment			(335,742	)			(270,473	)
Total stockholders’ equity			22,678,793				24,447,581
Total liabilities and stockholders’ equity		$	29,754,460			$	31,841,804

 

 

Ainos, Inc.

Condensed Statements of Operations

(Unaudited)

 

		Three months ended March 31,
		2024				2023
Revenues		$	20,729			$	49,164
Cost of revenues			(26,754	)			(100,848	)
Gross loss			(6,025	)			(51,684	)
Operating expenses:
Research and development expenses			2,084,648				1,698,883
Selling, general and administrative expenses			1,029,418				762,465
Total operating expenses			3,114,066				2,461,348
Loss from operations			(3,120,091	)			(2,513,032	)
Non-operating (expenses) income, net:
Interest expense			(48,696	)			(9,273	)
Issuance cost of senior secured convertible note measured at fair value			(138,992	)			-
Fair value change for senior secured convertible note			(31,568	)			-
Other income, net			24,537				1,830
Total non-operating expenses, net			(194,719	)			(7,443	)
Net loss before income taxes			(3,314,810	)			(2,520,475	)
Provision for income taxes			-				-
Net loss		$	(3,314,810	)		$	(2,520,475	)
Net loss per common share - basic and diluted		$	(0.57	)		$	(0.63	)
Weighted-average shares used in computing net loss per common share-basic and diluted			5,771,283				4,002,210

 

 

v3.24.1.1.u2

Cover	May 13, 2024
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 13, 2024
Entity File Number	001-41461
Entity Registrant Name	AINOS, INC.
Entity Central Index Key	0001014763
Entity Tax Identification Number	75-1974352
Entity Incorporation, State or Country Code	TX
Entity Address, Address Line One	8880 Rio San Diego Drive
Entity Address, Address Line Two	Ste. 800
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92108
City Area Code	(858)
Local Phone Number	869-2986
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false
Common Stock, par value $0.01 per share
Title of 12(b) Security	Common Stock, par value $0.01 per share
Trading Symbol	AIMD
Security Exchange Name	NASDAQ
Warrants to purchase Common Stock
Title of 12(b) Security	Warrants to purchase Common Stock
Trading Symbol	AIMDW
Security Exchange Name	NASDAQ

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