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Ainos Reports First Quarter 2024 Financial Results

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Ainos, a diversified healthcare company, released its Q1 2024 financial results. The company reported a strategic shift from COVID-19 rapid test kits, affecting near-term revenues, with Q1 revenue dropping to $20,729 from $49,164 in Q1 2023. Cost of revenues also decreased to $26,754 from $100,848. Despite this, gross profit improved, narrowing the loss to $6,025 from a $51,684 loss a year ago. Total operating expenses rose to $3.11M, attributed to higher clinical trial fees and research costs. Net loss widened to $3.31M from $2.52M. Recent financing efforts secured $9M in growth capital and an additional $1.75M in January 2024, bolstering Ainos' position for continued growth. CEO Chun-Hsien Tsai emphasized the focus on AI Nose and VELDONA technologies, exploring new markets, and advancing clinical studies.

Positive
  • Gross profit improved from a $51,684 loss to a $6,025 loss.
  • Secured $9 million in convertible note financing in May 2024.
  • Raised up to $1.75 million in additional financing in January 2024.
  • Focusing on diversifying business with AI Nose and VELDONA technologies.
  • Received Orphan Drug Designation from the FDA for VELDONA candidate treating oral warts in HIV-positive patients.
Negative
  • Q1 2024 revenue decreased to $20,729 from $49,164 in Q1 2023.
  • Net loss increased to $3.31M from $2.52M.
  • Total operating expenses rose to $3.11M from $2.46M.
  • R&D expenses increased to $2.08M from $1.69M.
  • Cash and cash equivalents dropped to $1.03M from $1.89M as of December 31, 2023.

Insights

Financial Performance: The company's revenue for Q1 2024 was $20,729, a significant drop from $49,164 in Q1 2023. This decline is directly linked to their strategic pivot away from COVID-19 rapid test kits, which previously contributed to their revenue stream. While this pivot aligns with their long-term strategy, it has negatively impacted short-term revenue, leading to a net loss of $3,314,810 compared to $2,520,475 last year.

Cost Management: One positive aspect is the decreased cost of revenues, from $100,848 in Q1 2023 to $26,754 in Q1 2024, due to lower sales volumes. However, operating expenses have increased significantly due to higher R&D and SG&A costs. This suggests that while the company is investing heavily in its future, it needs to manage these costs effectively to avoid further exacerbating losses.

Financing and Cash Position: The recent $9 million convertible note financing strengthens their financial position, providing essential capital for executing their growth strategy. However, cash and cash equivalents have decreased from $1,885,628 to $1,030,899, indicating the need for careful cash flow management.

Strategic Pivot: The shift from COVID-19 rapid test kits to a diversified focus on AI-powered point-of-care testing (POCT) and low-dose interferon therapeutics represents a significant strategic pivot. This move is aimed at long-term sustainability, leveraging advanced technologies like the AI Nose and VELDONA.

Product Development and Market Potential: The AI Nose technology, particularly aimed at creating an innovative VOC sensing platform with Japanese partners, has the potential to open new market opportunities in telehealth, automotive, industrial and environmental safety. This diversification can mitigate risks associated with over-reliance on a single product or market.

Clinical Trials and Regulatory Milestones: The progression of clinical studies for VELDONA, especially for treating oral warts in HIV-positive patients with Orphan Drug Designation, adds potential high-value therapeutic developments to their pipeline. However, the success of these trials and regulatory approvals will be important for their long-term success.

Clinical Research and Development: The emphasis on advancing VELDONA for treating oral warts in HIV-positive patients, alongside exploring applications for Sjögren's syndrome, indicates a robust R&D strategy. The Orphan Drug Designation by the U.S. FDA for the oral wart treatment can potentially expedite development and provide market exclusivity benefits if successful.

AI-Powered Technologies: The AI Nose technology's potential applications in telehealth and various industries showcase innovative steps in utilizing AI for healthcare advancements. Given the aging population, the AI-driven telehealth monitoring solution aiming to improve elderly care quality is particularly noteworthy.

Animal Health Market: The successful entry into the pet care market with VELDONA Pet supplement and plans to expand into the animal drug category reflect a diversification strategy that could tap into the growing pet care industry.

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, CA / ACCESSWIRE / May 13, 2024 / 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$800,305from 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

SOURCE: Ainos, Inc.



View the original press release on accesswire.com

FAQ

What were Ainos' Q1 2024 revenues?

Ainos reported Q1 2024 revenues of $20,729, down from $49,164 in Q1 2023.

How much financing did Ainos secure in May 2024?

Ainos secured $9 million through a convertible note financing in May 2024.

What is Ainos' strategic focus for 2024?

Ainos is focusing on AI Nose and VELDONA technologies, targeting new markets and advancing clinical studies.

What was Ainos' net loss in Q1 2024?

Ainos' net loss for Q1 2024 was $3.31 million, up from $2.52 million in Q1 2023.

What are Ainos' plans for VELDONA?

Ainos is advancing clinical studies and exploring out-licensing opportunities for VELDONA, including a candidate for treating oral warts in HIV-positive patients.

What was Ainos' gross profit in Q1 2024?

Ainos' gross profit in Q1 2024 was a loss of $6,025, improved from a $51,684 loss in Q1 2023.

How much did Ainos spend on R&D in Q1 2024?

Ainos' R&D expenses increased to $2.08 million in Q1 2024 from $1.69 million in Q1 2023.

What is the significance of the $9 million convertible note financing for Ainos?

The $9 million convertible note financing strengthens Ainos' financial position to execute its growth strategy.

What were Ainos' total operating expenses in Q1 2024?

Ainos' total operating expenses were $3.11 million in Q1 2024, up from $2.46 million in Q1 2023.

How much cash and cash equivalents did Ainos have as of March 31, 2024?

As of March 31, 2024, Ainos had cash and cash equivalents of $1.03 million.

Ainos, Inc.

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