Financial Performance - Revenues for fiscal year 2024 were $20,729, a significant decline from $122,112 in 2023, primarily due to lower sales of COVID-19 antigen rapid test kits [5]. - Cost of revenues decreased to $52,595 in 2024 from $375,845 in 2023, reflecting the reduced sales volume [6]. - Gross profit for 2024 was negative $31,866, an improvement from negative $253,733 in 2023, attributed to lower sales volume and reduced costs [7]. - Net loss attributable to common stock shareholders was $14,863,161 in 2024, compared to $13,770,549 in 2023 [11]. Operating Expenses - Total operating expenses increased to $13,809,338 in 2024 from $12,952,663 in 2023, driven by investments in AI Nose and VELDONA® development [8]. - Research and development expenses rose to $8,413,923 in 2024 from $7,317,388 in 2023, reflecting increased collaborative research and staffing costs [9]. - Selling, general and administrative expenses decreased to $5,395,415 in 2024 from $5,635,275 in 2023, mainly due to lower professional and public relations expenses [10]. Cash Position - As of December 31, 2024, cash and cash equivalents increased to $3,892,919 from $1,885,628 in 2023 [12]. Future Plans - Ainos plans to commence clinical studies for the second-generation Ainos Flora in H1 2025, aiming to establish leadership in the global POCT market [3]. - The company has received IRB approval for its clinical trial of VELDONA® in treating Sjögren's syndrome, with trials expected to begin in early 2025 [14].

Financial Performance - The company reported revenues of $20,729 for the year ended December 31, 2024, a decrease of 83% from $122,112 in 2023, primarily due to lower sales volume of COVID-19 Antigen Rapid Test Kits [263][264]. - The cost of revenues decreased to $52,595 in 2024 from $375,845 in 2023, reflecting a decline in sales volume of COVID-19 Antigen Rapid Test Kits [265]. - The company's operating loss increased by $634,808 to $13,841,204 in 2024, reflecting continued investment in growth strategy despite a gross loss in product sales [273]. - Net loss for 2024 was $14,863,161, an increase of $1,092,612 (8%) from $13,770,549 in 2023, attributed to increased non-exclusive use of certain patents related to VOC and POCT technologies [275]. Research and Development - Research and development (R&D) expenses increased by $1,096,535 (15%) to $8,413,923 in 2024, driven by increased staffing expenditures and co-research expenses [269]. - Clinical trial spending is expected to increase to advance VOC POCT and VELDONA drug candidates, alongside increased investment in R&D activities [290]. - The VOC co-development program achieved 79% accuracy in detecting 22 different volatile organic compounds (VOCs) in semiconductor factories [248]. Cash Flow and Financing - As of December 31, 2024, the company had available cash and cash equivalents of $3,892,919, up from $1,885,628 in 2023 [276]. - Net cash used in operating activities increased by $1,113,599, representing a 24% increase from 2023 to 2024, primarily due to a net loss for the year [278]. - Net cash used in investing activities rose to $125,292 in 2024 from $101,525 in 2023, a 23% increase attributed to higher refundable deposits and noncurrent assets [280]. - Cash provided by financing activities increased significantly by $3,102,073, reaching $8,025,746 in 2024, a 63% increase compared to $4,923,673 in 2023 [281]. - The company anticipates funding operations over the next twelve months through cash reserves, business revenues, and potential debt financing, with no assurance of achieving profitability [283]. - The company entered into an At The Market Offering Agreement on May 31, 2024, allowing for the issuance of shares based on market demand, with an aggregate offering price of $1,840,350 [286]. - The company plans to use net proceeds from the ATM offering to fund product development and general corporate purposes [287]. - As of December 31, 2024, no shares have been sold under the ATM Agreement [288]. Operational Expenses - Selling, general and administrative (SG&A) expenses slightly decreased by $239,860 (4%) to $5,395,415 in 2024, due to reduced professional expenses and public relations fees [271]. - The company may continue to incur operating losses in the near term as it grows its business, with expected increases in selling, general and administrative expenses, and R&D expenses [291]. Strategic Initiatives - The company signed a Memorandum of Understanding (MOU) with Taiwan Tanabe Seiyaku Co., Ltd. for the manufacturing and promotion of its Sjögren's syndrome drug based on VELDONA [246]. - The company plans to conduct clinical studies in Taiwan for VELDONA related to HIV-related oral warts and Sjögren's syndrome in 2025 [247]. Miscellaneous - The company had no off-balance sheet arrangements as of December 31, 2024 [299].

Core Viewpoint - Ainos has been granted a 180-day extension by Nasdaq to regain compliance with the minimum bid price rule, allowing the company additional time to meet the required stock price threshold [1] Group 1 - The extension is a response to Ainos' stock price falling below the minimum bid price of $1 per share [1] - Ainos must achieve a closing bid price of at least $1 per share for a minimum of 10 consecutive trading days during the extension period [1] - The company has until May 6, 2024, to regain compliance with Nasdaq's listing requirements [1]

Core Viewpoint - Ainos, Inc. has signed a Memorandum of Understanding (MOU) with Taiwan Tanabe Seiyaku Co., Ltd. to advance the manufacturing and market promotion of its Sjögren's syndrome drug, VELDONA® [3][6]. Market Demand for Sjögren's Syndrome Treatment - Sjögren's syndrome is an autoimmune disease with a significant unmet need for effective treatments, affecting millions globally. The global market for Sjögren's syndrome treatment is projected to reach billions of dollars in the next five years due to increasing awareness and an aging population [4]. VELDONA®'s Clinical Progress and Success - VELDONA®, a low-dose oral interferon-alpha, has shown remarkable potential in clinical trials, significantly alleviating symptoms and improving quality of life for patients. The drug has demonstrated strong tolerability and safety, laying a solid foundation for further large-scale global clinical trials [5]. Partnership with Taiwan Tanabe Seiyaku - Taiwan Tanabe Seiyaku brings extensive pharmaceutical development and market expansion experience to the partnership. The collaboration will focus on the manufacturing and promotion of VELDONA® to meet market demand, with specific details to be clarified under the MOU [6]. Global Market Impact and Future Outlook - The collaboration is expected to accelerate the global introduction of VELDONA®, ensuring timely access for patients. As more clinical data is collected, demand for VELDONA® is anticipated to solidify its position as a leading treatment for Sjögren's syndrome, potentially opening opportunities in other autoimmune diseases [7]. Ainos' Future Vision - Ainos is committed to driving medical innovation and addressing unmet medical needs globally. The partnership with Taiwan Tanabe Seiyaku is a significant milestone in Ainos' global strategy, focusing on developing breakthrough therapies to improve patient quality of life [8].

Revenue Performance - The company reported nil revenue in Q3 2024, down from $24,489 in Q3 2023, due to the cessation of Ainos COVID-19 antigen rapid test kit sales and offset by sales returns of VELDONA Pet[125]. - Revenues for the first nine months of 2024 were $20,729, a decrease of $81,479 (80%) from $102,208 in the same period of 2023[137]. Expenses - Research and Development (R&D) expenses increased by $311,979 (18%) to $2,022,244 in Q3 2024, driven by co-research and staffing expenditures[128]. - Selling, General and Administrative (SG&A) expenses rose by $113,741 (13%) to $1,015,758 in Q3 2024, attributed to increased staffing and professional expenses[131]. - The Company's operating loss increased by $362,883 (14%) to $3,038,549 in Q3 2024 from $2,675,666 in Q3 2023[133]. - Research and development (R&D) expenses increased by $1,005,313 (20%) to $6,085,648 in the first nine months of 2024 from $5,080,335 in the same period of 2023[141]. - Selling, general and administrative (SG&A) expenses rose by $807,425 (35%) to $3,090,056 in the first nine months of 2024 compared to $2,282,631 in the same period of 2023[143]. Net Loss - The company incurred a net loss of $3,699,317 in Q3 2024, compared to a net loss of $2,975,846 in Q3 2023, reflecting a 24% increase in losses[124]. - Net loss for Q3 2024 was $3,699,317, reflecting a $723,471 (24%) increase compared to $2,975,846 in Q3 2023[135]. - Net loss for the first nine months of 2024 was $10,209,149, representing a $2,363,101 (30%) increase from $7,846,048 in the first nine months of 2023[149]. Cash Flow - As of September 30, 2024, the company had available cash and cash equivalents of $5,156,606, with plans to raise additional capital to fund operations[120]. - Cash used in operating activities increased by $1,622,282 to $4,944,036 in the first nine months of 2024 compared to $3,321,754 in the same period of 2023[151]. - Cash provided by financing activities increased by $4,271,772 to $8,295,746 in the first nine months of 2024 from $4,023,974 in the same period of 2023[153]. Clinical and Product Development - The company has initiated clinical studies for HIV oral warts and Sjögren's syndrome in Taiwan, with the U.S. FDA granting orphan drug designation for the VELDONA formulation[114]. - The company is developing a next-generation Ainos Flora device for at-home testing, utilizing compute unified device architecture (CUDA) for enhanced performance[114]. - The company has licensed additional patents to strengthen its AI Nose and POCT technologies, including a patent for treating coronavirus infection[119]. - The company expects to increase spending on clinical trials and R&D activities in the near term to advance its VOC POCT and VELDONA drug candidates[156]. Strategic Goals - The company aims to create multiple revenue streams through commercialization of its product portfolio and strategic partnerships[118].

Core Insights - Ainos, Inc. has achieved a significant milestone with its AI Nose technology, demonstrating 79% accuracy in detecting 761 samples across 22 volatile organic compounds (VOCs) in semiconductor manufacturing factories [1][2][4] - The AI Nose technology is poised to enhance safety and efficiency in smart manufacturing by integrating into robotics systems, allowing for real-time monitoring and prevention of hazardous gas leaks [2][3] Group 1: Technology and Applications - The AI Nose has consistently performed well in medical applications and is now expanding into industrial sectors, showcasing its potential in smart manufacturing [2] - Key applications of AI Nose include contamination control in manufacturing processes, health and safety assurance by detecting chemical leaks, and fire prevention through monitoring overheating in equipment [2][3] - The integration of gas sensing technologies is essential for modern smart manufacturing, with AI Nose providing real-time feedback to ensure factory safety [2] Group 2: Future Developments - Ainos plans to integrate AI Nose into robotics systems, enabling robots to detect hazardous gases and collaborate more effectively with human workers [3] - The company anticipates further improvements in accuracy as more data is collected from co-developers and smart manufacturing facilities [4] - Ainos aims to position AI Nose as a leading technology in VOC sensing, enhancing industrial automation and safety measures [3][4]

Patent Licensing and Strategic Impact - Ainos secured exclusive licenses for 10 patents related to gas sensors and medical devices from Taiwan Carbon Nano Technology, its affiliate and co-developer [1] - The patents cover key regions including the US, Germany, China, Japan, and Taiwan [1] - The acquisition was made in exchange for AIMD stock worth $5.4 million [1] - The licensing is expected to strengthen Ainos' AI Nose and POCT technologies, particularly its VOC POCT candidate, Ainos Flora, and a VOC sensing platform developed with Japanese partners [2] Stock Performance and Market Reaction - AIMD stock surged 37.9% on Monday morning following the announcement [3] - Trading volume exceeded 9 million shares, significantly higher than the daily average of 793,000 shares [3] Industry Context - The news highlights Ainos' focus on advancing medical technology through strategic partnerships and intellectual property acquisition [1][2] - The company's emphasis on VOC sensing and POCT technologies aligns with growing demand for innovative medical diagnostics [2]

Revenue Performance - Revenues for Q2 2024 were nil, a decline from US$28,555 in Q2 2023, due to the cessation of COVID-19 antigen rapid test kit sales[5]. - Revenues for the three months ended June 30, 2024, were $28,555, compared to $20,729 for the same period in 2023, indicating a year-over-year increase of approximately 37%[27]. Cost and Expenses - Cost of revenues decreased to US$25,373 in Q2 2024 from US$55,817 in Q2 2023, primarily due to lower sales volume[6]. - Total operating expenses increased to US$3,023,636 in Q2 2024 from US$2,289,336 in Q2 2023, driven by higher co-research and staffing expenditures[8]. - SG&A expenses increased to US$1,044,880 in Q2 2024 from US$618,149 in Q2 2023, with non-cash expenses excluded, SG&A rose to US$706,211 from US$497,124[11]. - Total operating expenses for the three months ended June 30, 2024, were $3,023,636, an increase from $2,289,336 in the same period of 2023, reflecting a rise of about 32%[27]. - Research and development expenses for the six months ended June 30, 2024, were $4,063,404, up from $3,370,070 in the same period of 2023, reflecting an increase of about 20%[27]. Profitability - Gross profit was negative US$25,373 in Q2 2024, an improvement from negative US$27,262 in Q2 2023[7]. - Net loss attributable to common stock shareholders was US$3,195,022 in Q2 2024, compared to US$2,349,727 in Q2 2023[12]. - Gross loss for the six months ended June 30, 2024, was $31,398, compared to $78,946 for the same period in 2023, showing a reduction in gross loss of approximately 60%[27]. - Net loss for the three months ended June 30, 2024, was $3,195,022, compared to $2,349,727 for the same period in 2023, representing an increase in net loss of approximately 36%[27]. Cash and Assets - Cash and cash equivalents as of June 30, 2024, were US$8,014,098, up from US$1,885,628 as of December 31, 2023[13]. - Cash and cash equivalents increased significantly to $8,014,098 as of June 30, 2024, from $1,885,628 as of December 31, 2023, marking an increase of over 324%[25]. - Total assets increased to $35,539,387 as of June 30, 2024, up from $31,841,804 as of December 31, 2023, representing a growth of approximately 11%[25]. Liabilities and Equity - Total current liabilities rose to $5,743,199 as of June 30, 2024, compared to $1,336,838 as of December 31, 2023, indicating an increase of approximately 329%[25]. - Total liabilities increased to $14,827,111 as of June 30, 2024, from $7,394,223 as of December 31, 2023, representing an increase of approximately 100%[25]. - Stockholders' equity decreased to $20,712,276 as of June 30, 2024, down from $24,447,581 as of December 31, 2023, indicating a decline of approximately 15%[25]. Research and Development - R&D expenses rose to US$1,978,756 in Q2 2024 from US$1,671,187 in Q2 2023, reflecting increased technology and product research costs[10]. - The company aims to complete enrollment of 30 subjects for the FCGS clinical study by the end of 2024, with trial report expected in Q1 2025[14]. - Ainos is targeting Q3 2024 for design completion and Q4 2024 for clinical trial kickoff of the Next-Gen Ainos Flora VOC POCT device[15].

Revenue Performance - Ainos reported nil revenue in Q2 2024, down from $28,555 in Q2 2023, due to the cessation of COVID-19 test kit sales and limited sales of VELDONA Pet[120]. - Revenues for H1 2024 were $20,729, a decrease of $56,990 (73%) compared to $77,719 in H1 2023, primarily due to the cessation of sales of Ainos COVID-19 antigen rapid test kits[131]. Cost of Revenue - The cost of revenue in Q2 2024 was $25,373, a decrease of 55% from $55,817 in Q2 2023, attributed to reduced sales volume[121]. - Cost of revenues in H1 2024 was $52,127, down $104,538 (67%) from $156,665 in H1 2023, attributed to decreased sales volume[132]. Gross Loss - Gross loss from product sales was $25,373 in Q2 2024, slightly improved from a gross loss of $27,262 in Q2 2023[122]. - Gross loss for H1 2024 was $31,398, a reduction of $47,548 (60%) from a gross loss of $78,946 in H1 2023, due to lower sales volume and cost of revenue[133]. Research and Development Expenses - Research and development (R&D) expenses increased by 18% to $1,978,756 in Q2 2024 from $1,671,187 in Q2 2023, driven by co-research and staffing expenditures[123]. - R&D expenses increased by $693,334 (21%) to $4,063,404 in H1 2024 from $3,370,070 in H1 2023, driven by co-research and staffing expenditures[135]. Selling, General and Administrative Expenses - Selling, general and administrative (SG&A) expenses rose by 69% to $1,044,880 in Q2 2024 from $618,149 in Q2 2023, due to increased staffing and professional expenses[125]. - SG&A expenses rose by $693,684 (50%) to $2,074,298 in H1 2024 from $1,380,614 in H1 2023, reflecting increased staffing and professional expenses[137]. Operating Loss - The operating loss increased by 32% to $3,049,009 in Q2 2024 from $2,316,598 in Q2 2023, reflecting ongoing investments in growth strategies[127]. - Operating loss increased by $1,339,470 (28%) to $6,169,100 in H1 2024 compared to $4,829,630 in H1 2023, due to higher operating expenses[139]. Net Loss - Net loss for Q2 2024 was $3,195,022, a 36% increase from $2,349,727 in Q2 2023, primarily due to rising operating expenses[129]. - Net loss for H1 2024 was $6,509,832, an increase of $1,639,630 (34%) from $4,870,202 in H1 2023, primarily due to expanding operating expenses[141]. Financing Activities and Cash Position - Cash provided by financing activities increased significantly to $9,777,500 in H1 2024 from $2,185,974 in H1 2023, reflecting new funding received[145]. - As of June 30, 2024, the company had available cash of $8,014,098, up from $1,885,628 at the end of 2023[142]. Future Plans - Ainos plans to advance its VOC POCT candidate, Ainos Flora, and develop a VOC sensing platform in collaboration with partners[115]. - The company aims to leverage its intellectual property to create multiple revenue streams through commercialization and strategic partnerships[114]. - The company anticipates increased spending on clinical trials and R&D activities to advance its product candidates in the near term[146].

Financial Performance - In Q1 2024, the company reported revenues of $20,729, a decrease of 58% from $49,164 in Q1 2023, primarily due to the cessation of COVID-19 antigen rapid test kit sales[107][108]. - The cost of revenues in Q1 2024 was $26,754, down from $100,848 in Q1 2023, reflecting a decrease in sales volume[109]. - The gross loss for Q1 2024 was $6,025, significantly reduced from a gross loss of $51,684 in Q1 2023, attributed to lower sales volume and reduced cost of revenue[110]. - The company's operating loss increased by 24% to $3,120,091 in Q1 2024 from $2,513,032 in Q1 2023, reflecting ongoing investments in growth strategies[116]. - Net loss for Q1 2024 was $3,314,810, a 32% increase from $2,520,475 in Q1 2023, primarily due to rising operating expenses[119]. Expenses - Research and development (R&D) expenses increased by 23% to $2,084,648 in Q1 2024 from $1,698,883 in Q1 2023, driven by clinical trial fees and staffing expenditures[112]. - Selling, general and administrative (SG&A) expenses rose by 35% to $1,029,418 in Q1 2024 compared to $762,465 in Q1 2023, due to increased share-based compensation and professional expenses[114]. Cash Flow and Investments - As of March 31, 2024, the company had cash and cash equivalents of $1,030,899, down from $1,885,628 at the end of 2023[120]. - Cash used for investing activities increased to $111,280 in Q1 2024 from $72,483 in Q1 2023, primarily due to an increase in refundable deposits and other noncurrent assets[123]. - Cash provided by financing activities decreased to $777,500 in Q1 2024 from $800,000 in Q1 2023, reflecting a decrease of $22,500[124]. Future Plans and Strategies - The company plans to advance its flagship VOC POCT candidate, Ainos Flora, and co-develop a VOC sensing platform with partners, pivoting away from COVID-19 test kits[102]. - The company aims to leverage its intellectual property and develop multiple revenue streams through commercialization of its product portfolio[100]. - The company expects an increase in clinical trial spending to advance VOC POCT and VELDONA drug candidates, along with increased investment in R&D activities[125]. - The company anticipates that cash reserves, business revenues, and potential debt financing will fund operations over the next twelve months, with no assurance of achieving profitability[126]. Accounting and Reporting - Management's financial analysis is based on unaudited condensed financial statements prepared in accordance with U.S. GAAP[127]. - The company evaluates estimates related to inventory valuation, useful lives of property and equipment, and impairment testing of intangible assets on an ongoing basis[128]. - There have been no material changes to critical accounting policies and estimates compared to the previous annual report, except for those discussed in the notes[129]. - The company is classified as a smaller reporting company and is not required to provide additional market risk disclosures[130].