Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented, "In Q3, we made significant strides in executing our strategic roadmap for advancing our VELDONA® and AI Nose platforms. In our VELDONA® human drug program, we are focusing on clinical trials for rare diseases that have few treatment options, such as HIV-related oral warts and Sjögren's syndrome. Both of these studies will commence in Taiwan. Our VELDONA animal drug initiatives have also gained momentum, as we continue to enroll subjects in a Taiwanese clinical study focused on feline chronic gingivostomatitis ("FCGS"), a cat oral infection. Furthermore, for VELDONA®, we expanded our intellectual properties portfolio with a new Taiwan patent for the treatment and prevention of coronavirus. Global patent protection has already been filed for this patent, underscoring our commitment to developing innovative, effective healthcare solutions."
"For our proprietary AI Nose platform, we obtained exclusive patent licenses from our strategic shareholder and product co-developer. These enhancements bolster our intellectual property in volatile organic compounds ("VOC") detection, fortifying our aim to digitize scent and eventually serve as AI's olfactory system. AI Nose has already demonstrated impressive capability beyond healthcare, reaching 79% accuracy in detecting 22 different VOCs in Japanese semiconductor factories."
"In the near-term, our focus remains on advancing our flagship VOC POCT candidate, Ainos Flora, alongside co-development programs. In Q4, we aim to commence a clinical study in Taiwan for the next-generation Ainos Flora and be ready for pilot production for our co-development initiatives. Additionally, we are committed to fully utilizing the VELDONA® platform to build a robust product portfolio addressing diverse therapeutic needs. Looking ahead, we remain dedicated to advancing our clinical studies, targeting the completion of two key human trials in 2026 while actively pursuing out-licensing opportunities for VELDONA® drug candidates."
Christopher Lee, Chief Financial Officer of Ainos, commented, "Throughout this period, we maintained prudent cost management while strategically prioritizing our R&D investments to drive long-term growth. I'm pleased to report the full repayment of the convertible note financing from The Lind Partners in Q3, highlighting our focus on disciplined capital management. Our higher operating expenses in Q3 were primarily driven by investments in R&D, demonstrating our commitment to progressing clinical trials and product development initiatives for VELDONA® and our AI Nose-powered POCTs. We are better capitalized compared to the same period last year. With healthy cash reserves and strong focus on cost-effective operations, we are well-positioned to support our growth initiatives and development milestones."
Third Quarter 2024 Financial Results
Revenues
Revenues were nominal in the third quarter of 2024, nil compared to US$24,489 in the same period of 2023. This decline reflects the Company's cessation of sales of its COVID-19 antigen rapid test kits after a strategic pivot shift and the sales returns that offset sales volume during the quarter.
Cost of Revenues
Cost of revenues was US$547 in the third quarter of 2024, compared to US$87,873 in the same period of 2023. The decrease was primarily attributable to the decrease in sales volume.
Gross Profit
In the third quarter of 2024, gross profit was negative US$547, narrowing from negative US$63,384 in the third quarter of 2023, due to lower sales volumes of the Company's newly launched products and reduced cost of revenues.
Total Operating Expenses
Total operating expenses were US$3,038,002 in the third quarter of 2024, compared to US$2,612,282 in the same period of 2023. The change was mainly attributable to increased expenses associated with co-research for technology, product and staffing expenditures, and increases in share-based compensation and professional expenses.
R&D expenses increased to US$2,022,244 in the third quarter of 2024 from US$1,710,265 in the same period of 2023. The increase was primarily due to increased expenses associated with co-research for technology and product, as well as staffing expenditures. Share-based compensation expenses and depreciation and amortization expenses in the third quarter of 2024 were US$1,305,461, compared with US$1,263,665 in the third quarter of 2023. Excluding these non-cash expenses, R&D expenses increased to US$716,783 from US$446,600 over the same period.
SG&A expenses increased to US$1,015,758 in the third quarter of 2024 from US$902,017 in the same period of 2023. Share-based compensation expenses and depreciation and amortization expenses in the third quarters of 2024 and 2023 were US$377,020 and US$269,934, respectively. Excluding these non-cash expenses, SG&A expenses mildly increased to US$638,738 from US$632,083 over the same period.
Net Loss
Net loss attributable to common stock shareholders was US$3,699,317 in the third quarter of 2024, compared to US$2,975,846 in the same period of 2023.
Balance Sheet
As of September 30, 2024, the Company had cash and cash equivalents of US$5,156,606, compared to US$1,885,628 as of December 31, 2023.
Recent Business Developments
On October 28, 2024, the Company secured exclusive licensing rights for an additional 28 multi-regional patent assets from our strategic shareholder and product co-developer. These patents encompass cutting-edge innovations in AI Nose gas sensing technology and extend Ainos' technological capabilities with a groundbreaking nitrogen-oxygen separation technology targeting medical applications.
On September 23, 2024, the Company announced its plans to conduct a clinical trial in Taiwan to evaluate VELDONA® for treating Sjögren's syndrome at Taipei Medical University-Shuang Ho Hospital. A total of eight clinical trials have been conducted in the U.S. and three Prior Phase 3 studies show positive benefits in increasing unstimulated whole saliva secretion without significant adverse effects.
On September 17, 2024, the Company announced its plans to initiate a clinical study for VELDONA® on treating HIV-related oral warts at the National Taiwan University Hospital (the "Hospital") to evaluate its efficacy. For this indication, VELDONA® has received orphan drug designation from the U.S. Food and Drug Administration ("FDA"). On September 25, 2024, Ainos received Institutional Review Board (IRB) approval from the Hospital for this clinical trial.
On September 3, 2024, the Company announced that it has secured an invention patent in Taiwan for VELDONA® formulation and has filed for global patent protection under the Patent Cooperation Treaty (PCT). This patent represents a significant milestone in the treatment and prevention of coronavirus infections.
On August 19, 2024, the Company said its AI Nose has made a key breakthrough in factory automation with 79% accuracy in detecting 761 samples across 22 different VOCs. This is a remarkable technological advancement in industrial manufacturing safety and smart manufacturing. Company also intends to explore integrating AI Nose into robots, enabling robots and humanoids to intelligently sense surroundings and better collaborate with human.
On August 9, 2024, the Company announced that it has obtained exclusive licenses from its strategic shareholder and product co-developer, bolstering both AI Nose and POCT. The newly licensed 10 invention patents and patent applications cover gas sensors and medical devices.
On August 6, 2024, the Company concluded its remaining convertible note financing from The Lind Partners, through conversions of the Note by the investor and payments by the Company.
About Ainos, Inc.
Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on novel AI-powered point-of-care testing (POCT) and VELDONA low-dose interferon therapeutics. The Company's clinical-stage product pipeline includes VELDONA human and animal oral therapeutics, human orphan drugs, and telehealth-friendly POCT solutions powered by its AI Nose technology platform.
The name "Ainos" is a combination of "AI" and "Nose" to reflect the Company's commitment to empowering individuals to manage their health more effectively with next-generation AI-driven POCT solutions. 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 Statements
Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. 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 public filings 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 filings 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
Email: IR@ainos.com
Ainos, Inc.
Condensed Balance Sheets
(Unaudited)
| | | September 30, | | | December 31, | |
| | | 2024 | | | 2023 | |
| | | | | | | |
| ASSETS | | | | | | |
| Current assets: | | | | | | |
| Cash and cash equivalents | | $ | 5,156,606 | | | $ | 1,885,628 | |
| Accounts receivable | | | - | | | | 455 | |
| Inventory, net | | | 160,701 | | | | 167,593 | |
| Other current asset | | | 331,898 | | | | 419,521 | |
| Total current assets | | | 5,649,205 | | | | 2,473,197 | |
| Intangible assets, net | | | 24,888,249 | | | | 28,283,208 | |
| Property and equipment, net | | | 649,063 | | | | 876,572 | |
| Other assets | | | 183,229 | | | | 208,827 | |
| Total assets | | $ | 31,369,746 | | | $ | 31,841,804 | |
| Liabilities and Stockholders' Equity | | | | | | | | |
| Current liabilities: | | | | | | | | |
| Contract liabilities | | $ | 110,142 | | | $ | 112,555 | |
| Convertible notes payable | | | 3,000,000 | | | | - | |
| Other notes payable, related party | | | 270,000 | | | | 42,000 | |
| Accrued expenses and others current liabilities | | | 750,629 | | | | 1,182,283 | |
| Total current liabilities | | | 4,130,771 | | | | 1,336,838 | |
| Senior secured convertible notes measured at fair value | | | - | | | | 2,651,556 | |
| Convertible notes payable - noncurrent | | | 9,000,000 | | | | 3,000,000 | |
| Other notes payable, related party - noncurrent | | | - | | | | 270,000 | |
| Other long-term liabilities | | | 216,760 | | | | 135,829 | |
| Total liabilities | | | 13,347,531 | | | | 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 September 30, 2024 and December 31, 2023, 13,813,434 and 4,677,787 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | | | 138,134 | | | | 46,778 | |
| Common stock to be issued,900shares and 162,337 shares as of September 30, 2024 and December 31, 2023, respectively | | | 9 | | | | 1,623 | |
| Additional paid-in capital | | | 66,223,783 | | | | 62,555,808 | |
| Accumulated deficit | | | (48,095,304 | ) | | | (37,886,155 | ) |
| Accumulated other comprehensive loss - translation adjustment | | | (244,407 | ) | | | (270,473 | ) |
| Total stockholders' equity | | | 18,022,215 | | | | 24,447,581 | |
| Total liabilities and stockholders' equity | | $ | 31,369,746 | | | $ | 31,841,804 | |
Ainos, Inc.
Condensed Statements of Operations
(Unaudited)
| | | Three months ended September 30, | | | Nine months ended September 30, | |
| | | 2024 | | | 2023 | | | 2024 | | | 2023 | |
| | | | | | | | | | | | | |
| Revenues | | $ | - | | | $ | 24,489 | | | $ | 20,729 | | | $ | 102,208 | |
| Cost of revenues | | | (547 | ) | | | (87,873 | ) | | | (52,674 | ) | | | (244,538 | ) |
| Gross loss | | | (547 | ) | | | (63,384 | ) | | | (31,945 | ) | | | (142,330 | ) |
| Operating expenses: | | | | | | | | | | | | | | | | |
| Research and development expenses | | | 2,022,244 | | | | 1,710,265 | | | | 6,085,648 | | | | 5,080,335 | |
| Selling, general and administrative expenses | | | 1,015,758 | | | | 902,017 | | | | 3,090,056 | | | | 2,282,631 | |
| Total operating expenses | | | 3,038,002 | | | | 2,612,282 | | | | 9,175,704 | | | | 7,362,966 | |
| Loss from operations | | | (3,038,549 | ) | | | (2,675,666 | ) | | | (9,207,649 | ) | | | (7,505,296 | ) |
| | | | | | | | | | | | | | | | | |
| Non-operating (expenses) income, net: | | | | | | | | | | | | | | | | |
| Interest expense | | | (264,642 | ) | | | (44,267 | ) | | | (432,097 | ) | | | (93,852 | ) |
| Issuance cost of senior secured convertible note measured at fair value | | | (169,344 | ) | | | (260,967 | ) | | | (308,336 | ) | | | (260,967 | ) |
| Fair value change for senior secured convertible note | | | (177,212 | ) | | | - | | | | (275,624 | ) | | | - | |
| Other income, net | | | (49,570 | ) | | | 5,054 | | | | 14,557 | | | | 14,067 | |
| Total non-operating expenses, net | | | (660,768 | ) | | | (300,180 | ) | | | (1,001,500 | ) | | | (340,752 | ) |
| | | | | | | | | | | | | | | | | |
| Net loss before income taxes | | | (3,699,317 | ) | | | (2,975,846 | ) | | | (10,209,149 | ) | | | (7,846,048 | ) |
| Provision for income taxes | | | - | | | | - | | | | - | | | | - | |
| Net loss | | $ | (3,699,317 | ) | | $ | (2,975,846 | ) | | $ | (10,209,149 | ) | | $ | (7,846,048 | ) |
SOURCE: Ainos, Inc.
View the original press release on accesswire.com
