Ainos Reports Full Year 2024 Financial Results
Rhea-AI Summary
Ainos (NASDAQ:AIMD) reported its fiscal year 2024 financial results, marking a transition from COVID-19 testing to advancing VELDONA® and AI Nose programs. The company's AI Nose program achieved up to 94% accuracy in clinical trials for women's health testing, while its VOC detection platform showed 80% accuracy in semiconductor applications.
Financial highlights include:
- Revenue declined to $20,729 in 2024 from $122,112 in 2023
- Net loss increased to $14.86M from $13.77M in 2023
- Cash position improved to $3.89M from $1.89M year-over-year
- R&D expenses rose to $8.41M from $7.32M
- SG&A expenses decreased to $5.40M from $5.64M
Key developments include a partnership with Taiwan Tanabe Seiyaku for VELDONA® manufacturing and IRB approval for Sjögren's syndrome clinical trials. The company plans to commence second-generation Ainos Flora clinical studies in H1 2025 and aims to submit IND applications to the FDA by H2 2025.
Positive
- Secured IRB approval for Sjögren's syndrome clinical trials
- Strategic partnership with Taiwan Tanabe Seiyaku for VELDONA®
- AI Nose achieved 94% accuracy in clinical trials
- Cash position improved by 106% to $3.89M
- Reduced SG&A expenses to $5.40M
Negative
- Revenue declined 83% to $20,729
- Net loss increased to $14.86M
- R&D expenses increased 15% to $8.41M
- Negative gross profit of $31,866
Insights
Ainos's 2024 financial results highlight a strategic transition with significant cost implications. Revenue plummeted 83% to just
The financial fundamentals remain concerning with minimal revenue generation and increasing losses. R&D expenses increased 15% to
The transition from diagnostic testing to platform technologies represents a fundamental business model shift with extended commercialization timelines. While management highlighted promising clinical results for AI Nose (94% accuracy in women's health applications) and plans for commercial partnerships, investors should recognize the early development stage for both flagship programs. The Taiwan Tanabe partnership and Sjögren's syndrome IRB approval provide validation, but revenue generation remains distant with FDA applications not expected until H2 2025.
This creates a challenging financial outlook where R&D costs will likely continue rising while meaningful revenue remains years away, necessitating future capital raises and potential dilution.
Unveiled revolutionary AI Nose for robotics application, inviting global robotics companies to join Ainos Alliance in shaping the future of smell-enabled robots
Advanced VELDONA® development with key Japan patent, Taiwan Tanabe partnership, and IRB approval for Sjögren's syndrome clinical study
SAN DIEGO, CALIFORNIA / ACCESS Newswire / March 7, 2025 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQAIMDW) ("Ainos", or the "Company") today announced its financial results for the fiscal year ended December 31, 2024.
Chun-Hsien (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."
"Our 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
"In 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 Sjögren'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."
"As 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."
Christopher 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."
Fiscal Year 2024 Financial Results
Revenues
Revenues were US
Cost of Revenues
Cost of revenues was US
Gross Profit
In the fiscal year of 2024, gross profit was negative US
Total Operating Expenses
Total operating expenses were US
R&D expenses increased to US
SG&A expenses decreased to US
Net Loss
Net loss attributable to common stock shareholders was US
Balance Sheet
As of December 31, 2024, the Company had cash and cash equivalents of US
Recent Business Developments
On December 2, 2024, the Company announced a strategic partnership with Taiwan Tanabe Seiyaku to advance the manufacturing and market promotion of VELDONA® for Sjögren'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.
On 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 Sjögren'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.
About Ainos, Inc.
Headquartered 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 to stay up-to-date.
Safe Harbor Statement
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 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.
Investor Relations Contact
Feifei Shen
Email: IR@ainos.com
Ainos, Inc.
Condensed Balance Sheets
| December 31, |
| ||||||
| 2024 |
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| 2023 |
| |||
Assets |
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|
|
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| ||
Current assets: |
|
|
|
|
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| ||
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 |
|
|
|
|
|
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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 |
|
|
|
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|
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Stockholders' equity: |
|
|
|
|
|
|
|
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Preferred stock, |
|
| - |
|
|
| - |
|
Common stock, |
|
| 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 |
|
Ainos, Inc.
Condensed 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 | ) |
|
|
|
|
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|
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| |
Operating expenses: |
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|
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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 | ) |
SOURCE: Ainos, Inc.
View the original press release on ACCESS Newswire