Full Press Release Details
Reports Full Year 2024 Financial Results
revolutionary AI Nose for robotics application, inviting global robotics companies to join Ainos Alliance in shaping the future of smell-enabled
VELDONA development with key Japan patent, Taiwan Tanabe partnership, and IRB approval for Sj gren's syndrome clinical
DIEGO, CA / ACCESSWIRE /March 07, 2025 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) ("Ainos", or the "Company") today announced
its financial results for the fiscal year ended December 31, 2024.
(Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented, "2024 marked another pivotal year
as we transitioned from our COVID-19 antigen rapid test business to advancing the VELDONA and pioneering AI Nose programs. This
shift has positioned us at the forefront of transformative healthcare, industrial, and robotics applications, unlocking new pathways
for long-term growth."
AI Nose program has achieved meaningful milestones, particularly with Ainos Flora, our first-generation device designed to revolutionize
women's health and sexually transmitted infection testing. With up to 94% accuracy rates in clinical trials, we are set to commence
clinical studies for the second-generation Ainos Flora in H1 2025, while exploring commercialization opportunities to establish our leadership
in the global POCT market. Additionally, our AI-powered volatile organic compound ("VOC") detection platform, co-developed
with our Japanese partners, is poised to deliver telehealth-friendly, data-driven remote monitoring solutions for elderly care. It has
also shown nearly 80% accuracy in identifying 22 different VOCs in semiconductor factories, positioning us for mass production in H1
2025 and enhancing industrial safety and efficiency in the semiconductor industry. As we expand AI Nose applications beyond healthcare
into industrial and robotics sectors, we draw upon nearly a decade of expertise to invite global robotics companies to join the Ainos
Alliance. Our goal is to empower next-generation robots with the ability to "smell," filling a critical gap in sensory capabilities."
parallel, our VELDONA drug development pipeline is making progress in both human and animal health. We are prioritizing clinical
studies for HIV oral warts and Sj gren's syndrome, with trials set to begin this year in Taiwan and aim for submitting Investigational
New Drug (IND) applications to the U.S. Food and Drug Administration by H2 2025. We continue to gain ground on our out-licensing efforts
for human drug candidates through our partnership with Taiwan Tanabe Seiyaku Co., Ltd. while our recent obtainment of a pivotal invention
patent in Japan further strengthens our global intellectual property ("IP") portfolio. At the same time, we are also making
strides in our animal health initiatives with a Taiwanese clinical study targeting feline chronic gingivostomatitis, addressing an urgent
need for new treatment options."
we enter 2025, we remain committed to accelerating innovation, strengthening strategic partnerships, and expanding our IP portfolio to
reinforce our leadership in AI Nose development and immunotherapy."
Lee, Chief Financial Officer of Ainos, commented, "During the last year of strategic transition, we navigated through the financial
impact of shifting away from COVID-19 antigen rapid test. Additionally, Ainos remains capital-efficient and prudent in strategically
allocating resources to advance our key programs while maintaining financial flexibility. Excluding non-cash items, our operating expense
growth was primarily driven by continued investments in AI Nose and VELDONA development. At the same time, disciplined financial
management enabled us to reduce selling, general and administrative (SG&A) expenses. Looking ahead, we will continue prioritizing
investments in our core technology platforms while pursuing strategic partnerships to accelerate commercialization. While we anticipate
a near-term increase in research and development (R&D) expenses, we remain confident that our ongoing efforts to optimize costs and
diversify revenue sources will generate sustained growth."
Year 2024 Financial Results
were US$20,729 for the fiscal year 2024, compared to US$122,112 for the fiscal year of 2023. This decline reflects lower sales volume
of the Company's COVID-19 antigen rapid test kit and was partially offset by exchange rate fluctuations. We generated $408 and
$102,256 in revenues from COVID 19 antigen rapid test kits and $20,321 and $256 in revenues from pet supplements in 2024 and 2023, respectively.
of revenues was US$52,595 for the fiscal year 2024, compared to US$375,845 for the same period of 2023. The decrease was primarily attributable
to the decrease in sales volume.
the fiscal year of 2024, gross profit was negative US$31,866, narrowing from negative US$253,733 in the same period of 2023, due to lower
sales volume of the Company's newly launched products and reduced cost of revenues.
operating expenses were US$13,809,338 in the fiscal year 2024, compared to US$12,952,663 in the same period of 2023. The change was mainly
attributable to increased expenses associated with co-research for technology, product and staffing expenditures.
expenses increased to US$8,413,923 in the fiscal year 2024 from US$7,317,388 in the same period of 2023. The increase was primarily due
to increased expenses associated with collaborative technological research as well as staffing expenditures, partially offset by a decrease
in impairment loss and material expenses. Share-based compensation expenses and depreciation and amortization expenses in the fiscal
year 2024 were US$5,600,037, compared with US$5,252,730 in the fiscal year 2023. Excluding these non-cash expenses, R&D expenses
increased to US$2,813,886 from US$2,064,658 over the same period.
expenses decreased to US$5,395,415 in the fiscal year 2024 from US$5,635,275 in the same period of 2023. The decrease was primarily due
to lower professional expenses, public relations, investor relations fees and D&O insurance expenses, but offset by staffing expenditures
(including share-based compensation). Share-based compensation expenses and depreciation and amortization expenses in the fiscal year
2024 and 2023 were US$2,824,743 and US$2,886,216, respectively. Excluding these non-cash expenses, SG&A expenses decreased to US$2,570,672
from US$2,749,059 over the same period.
loss attributable to common stock shareholders was US$14,863,161 in the fiscal year 2024, compared to US$13,770,549 in the same period
of December 31, 2024, the Company had cash and cash equivalents of US$3,892,919, compared to US$1,885,628 as of December 31, 2023.
Business Developments
December 2, 2024, the Company announced a strategic partnership with Taiwan Tanabe Seiyaku to advance the manufacturing and market promotion
of VELDONA for Sj gren's syndrome in Taiwan. Previous clinical studies have demonstrated the strong tolerability and
safety of VELDONA , laying a solid foundation for more large-scale global clinical trials and opening doors to potential
treatments for other autoimmune diseases.
November 11, 2024, the Company received Institutional Review Board (IRB) approval from Shuang Ho Hospital, affiliated with Taipei Medical
University, for its clinical trial of VELDONA in treating Sj gren's syndrome. This approval is an achievement that ensures
Ainos remains aligned with its planned study timeline, with regulatory approvals and a site initiation visit expected in early 2025.
in San Diego, California, Ainos, Inc. develops disruptive medical and healthcare solutions based on its proprietary AI Nose and VELDONA
technologies. The name "Ainos" combines "AI" and "Nose" to signify the Company's commitment
to enabling AI with the ability to smell and individuals to live healthier. The Company's clinical-stage product pipeline includes
AI-driven, telehealth-friendly POCT solutions powered by AI Nose, VELDONA human and animal oral therapeutics, and human orphan drugs.
To learn more, visit https://www.ainos.com. Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn
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 are based on management's current assumptions and expectations of future events and trends,
which affect or may affect the Company's business, strategy, operations or financial performance, and actual results and other
events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking
statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of
important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated
by the forward-looking statements in this press release. These factors include, among other things, our expectation that we will incur
net losses for the foreseeable future; our ability to become profitable; our ability to raise additional capital to continue our product
development; our ability to accurately predict our future operating results; our ability to advance our current or future product candidates
through clinical trials, obtain marketing approval and ultimately commercialize any product candidates we develop; the ability to obtain
and maintain regulatory approval of our product candidates; delays in completing the development and commercialization of our current
and future product candidates; developing and commercializing additional products, including diagnostic testing devices; our ability
to compete in the marketplace; compliance with applicable laws, regulations and tariffs, and factors described in the Risk Factors section
of our public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to
risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking
statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes
no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,892,919 | $ | 1,885,628 | ||||
| Accounts receivable | 56 | 455 | ||||||
| Inventory, net | 143,756 | 167,593 | ||||||
| Other current assets | 301,077 | 419,521 | ||||||
| Total current assets | 4,337,808 | 2,473,197 | ||||||
| Intangible assets, net | 23,748,328 | 28,283,208 | ||||||
| Property and equipment, net | 559,645 | 876,572 | ||||||
| Other assets | 174,418 | 208,827 | ||||||
| Total assets | $ | 28,820,199 | $ | 31,841,804 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Contract liabilities | $ | 106,329 | $ | 112,555 | ||||
| Convertible notes payable | 3,000,000 | - | ||||||
| Other notes payable, related party | - | 42,000 | ||||||
| Accrued expenses and other current liabilities | 848,615 | 1,182,283 | ||||||
| Total current liabilities | 3,954,944 | 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 | 348,945 | 135,829 | ||||||
| Total liabilities | 13,303,889 | 7,394,223 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.01 par value; 50,000,000 shares authorized as of December 31, 2024 and 2023, respectively; none issued and outstanding | - | - | ||||||
| Common stock, $0.01 par value; 300,000,000 shares authorized as of December 31, 2024 and 2023; 15,427,385 shares and 4,677,787 shares issued and outstanding as of December 31, 2024 and 2023, respectively | 154,274 | 46,778 | ||||||
| Common stock to be issued, nil and 162,337 shares as of December 31, 2024 and 2023, respectively | - | 1,623 | ||||||
| Additional paid-in capital | 68,520,881 | 62,555,808 | ||||||
| Accumulated deficit | (52,749,316 | ) | (37,886,155 | ) | ||||
| Accumulated other comprehensive loss - translation adjustment | (409,529 | ) | (270,473 | ) | ||||
| Total stockholders' equity | 15,516,310 | 24,447,581 | ||||||
| Total liabilities and stockholders' equity | $ | 28,820,199 | $ | 31,841,804 |
Statements of Operations
| Years ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenues | $ | 20,729 | $ | 122,112 | ||||
| Cost of revenues | (52,595 | ) | (375,845 | ) | ||||
| Gross losses | (31,866 | ) | (253,733 | ) | ||||
| Operating expenses: | ||||||||
| Research and development expenses | 8,413,923 | 7,317,388 | ||||||
| Selling, general and administrative expenses | 5,395,415 | 5,635,275 | ||||||
| Total operating expenses | 13,809,338 | 12,952,663 | ||||||
| Loss from operations | (13,841,204 | ) | (13,206,396 | ) | ||||
| Non-operating (expenses) income | ||||||||
| Interest expense | (616,467 | ) | (144,193 | ) | ||||
| Issuance cost of senior secured convertible note measured at fair value | (308,336 | ) | (525,643 | ) | ||||
| Fair value change of senior secured convertible note | (275,624 | ) | 94,207 | |||||
| Other income, net | 179,270 | 12,276 | ||||||
| Total non-operating expenses, net | (1,021,157 | ) | (563,353 | ) | ||||
| Net loss before income taxes | (14,862,361 | ) | (13,769,749 | ) | ||||
| Provision for income taxes | 800 | 800 | ||||||
| Net loss | $ | (14,863,161 | ) | $ | (13,770,549 | ) |