Advanced Biomed Inc.

Advanced Biomed Inc. is a Nevada-incorporated holding company primarily focused on the design and development of microfluidic technology platforms for early cancer screening, detection, diagnosis, staging, and treatment assistance through its subsidiary, Advanced Biomed Taiwan ¹. The company also has Advanced Biomed HK, responsible for market operations, localized production, and product registration in China, with a Shanghai subsidiary managing R&D equipment, patents, and clinical trials in Mainland China through Contract Research Organizations (CROs) ¹. The core business model revolves around developing and commercializing medical testing equipment, microfluidic biochips, and immunostaining kits that leverage semiconductor technology and biotechnology to detect circulating tumor cells (CTCs) and related tumor markers in blood samples ¹. The company aims to provide rapid and affordable assay products and services to cancer patients, with a future plan to establish operation centers in North America and Europe ¹. As of the reporting date, the company has not commenced sales of its products and does not generate revenue, expecting continuous losses for the next two to three years ¹.

The company's product portfolio includes several devices and corresponding microfluidic biochips. A+Pre is an automated sample preparation system designed to reduce blood sample viscosity and deplete approximately 90% of blood cells in 10 minutes, reducing sample volume while recovering over 90% of targeted tumor cells ¹. The A+Pre Chip is a supporting consumable that utilizes microfluidic inertial forces for rapid pre-enrichment and pre-concentration of diluted blood samples ¹. AC-1000 is a rare cell enrichment device that uses semiconductor fabrication and patented microfluidic chip technology to separate rare cells with complete cell activity, achieving a capture rate of 76-90% of targeted cells and a leukocyte removal rate of 99.9% in 20 minutes for a 5ml blood sample ¹. The AC-1000 CTC Enrichment Chip facilitates this process by combining microfluidics-induced lateral displacement ¹.

Further products include A+SCDrop, a CTCs single-cell capture device that preserves the original viability of single cells and combines cell dielectric sensing technology for label-free live cell sorting into nanoliter droplet collection samples ¹. This device can sort single CTCs into 96-well plates for applications like single-cell sequencing and drug sensitivity testing ¹. A+CellScan is an analyzer with an immunostaining chip for rapid on-chip immunofluorescence staining and artificial intelligence analysis of enriched samples, detecting and counting rare CTCs/clusters with four-color immunofluorescent images in approximately 30 minutes per sample ¹. The A+CellScan Chip, with its 5 µm micro-pores membrane, facilitates on-chip immunostaining, significantly reducing total detection time by 4-5 hours per sample compared to conventional methods ¹.

Additionally, Advanced Biomed has developed four matching immunostaining kits: A+CTCE (for epithelial CTCs), A+CTCM (for mesenchymal CTCs), A+EMT (for epithelial-to-mesenchymal CTCs), and A+CM (for tumor-associated macrophages) ¹. These kits use antibodies combined with different colored fluorophores to bind to specific proteins for cell identification and determination ¹. The company's latest development is the A+PerfusC™ system, a compact, all-in-one perfusion-based 3D cell culture incubator designed to replicate human physiological conditions for forming 3D tumor spheroids/organoids in vitro, supporting up to 12 days of continuous, hands-free culture ¹. A+LCGuard, a Class III medical device for early lung cancer screening, assists in determining benign and malignant pulmonary nodules and is used in combination with A+Pre and AC-1000 ¹.

For the fiscal year ended June 30, 2025, Advanced Biomed reported a net loss of $3,258,969 ¹. This compares to a net loss of $2,782,278 for the fiscal year ended June 30, 2024 ¹. The company had no revenue from product sales for either period ¹. Total operating expenses for the year ended June 30, 2025, were $(3,021,036), an increase of 19% from $(2,541,572) in the prior year ¹. Research and development expenses slightly increased by $29,578, or 3%, to $(909,771) in 2025 from $(880,193) in 2024 ¹. General and administrative expenses rose by $449,886, or 27%, to $(2,111,265) in 2025 from $(1,661,379) in 2024 ¹. Interest income decreased by $28,580, or 53%, to $24,915 in 2025 from $53,495 in 2024 ¹. Other expense, net, amounted to $(262,848) in 2025, a decrease of 11% from $(294,201) in 2024 ¹. The company had a working capital surplus of $3,143,443 as of June 30, 2025, up from $318,650 as of June 30, 2024 ¹. Net cash used in operating activities was $(5,825,055) in 2025, compared to $(2,126,340) in 2024 ¹. Net cash used in investing activities was $(31,650) in 2025, down from $(74,110) in 2024 ¹. Net cash provided by financing activities was $5,934,301 in 2025, significantly higher than $1,866,820 in 2024 ¹. Cash at the end of the year was $2,903,915 in 2025, an increase from $2,607,973 in 2024 ¹.

The increase in general and administrative expenses in 2025 was primarily driven by a significant rise in legal and professional fees, which increased by $653,489 or 187%, to $1,003,489 from $350,000 ¹. Office supplies and upkeep expenses also saw a substantial increase of $98,984 or 196%, reaching $110,386 from $11,443 ¹. Travelling and entertainment expenses more than doubled, increasing by $19,112 or 101%, to $37,955 from $18,843 ¹. These increases were partially offset by decreases in staff costs by $257,469 or 34%, depreciation and amortization by $55,772 or 14%, and property and related expenses by $47,150 or 64% ¹. The company completed its initial public offering in 2025, issuing 1,640,000 shares of common stock at $4.00 per share, generating gross proceeds of $6.56 million ¹. On June 6, 2025, the company entered into an Equity Line of Credit (ELOC) Agreement with HELENA GLOBAL INVESTMENT OPPORTUNITIES I LTD., granting the right to issue and sell up to $25,000,000 of common stock ¹.

During the reported period, Advanced Biomed continued its research and development efforts, finalizing the R&D stage for four immunostaining kits and submitting their registration applications in China ¹. The A+LCGuard lung cancer early screening kit, a Class III medical device, completed its research, design, and development between August 2020 and September 2022 ¹. Clinical research for A+LCGuard is planned to begin in November 2025, with completion anticipated within six months ¹. The company collaborated with a CRO in June 2025 to draft the clinical research protocol and prepare materials ¹. A+Pre and AC-1000 devices and their corresponding chips have received NMPA clearance in China ¹. A+SCDrop, A+CellScan, A+CellScan Chip, and A+LCGuard are currently at the registration application stage, while the four immunostaining kits are under NMPA registration review ¹. Pre-mass production trial tests for A+Pre Chip and AC-1000 Enrichment Chip were conducted with Riva and Unimold, demonstrating that randomly selected chips met or exceeded production specifications, with average tumor cell recovery rates of 94% for A+Pre chips and 79.5% for AC-1000 chips ¹. The company purchased a Riva injection molding machine in October 2022 and completed mass production trial tests for AC-1000 chips, with each equipment expected to produce 2,000 pieces per month ¹. A small-scale trial production of 5,000 A+Pre Chips was carried out in October 2022, with one injection-type production equipment expected to produce 50,000 pieces per month ¹.

Advanced Biomed anticipates being in a state of continuous loss for the next two to three years, as it has not yet commenced sales of its products or generated revenue from product candidates ¹. The company's ability to continue as a going concern is dependent on its capacity to develop, register, and obtain regulatory approval for commercial sales of its products to generate positive operating cash flows ¹.

A significant growth area for the company is the expansion into North American and European markets. Advanced Biomed plans to establish subsidiaries and localize production and operations in these regions to meet specific market demands and compliance requirements ¹. Specifically, the company is seeking suitable locations in California and Washington for its North America expansion, aiming to complete site selection and personnel recruitment in the United States by the end of December 2025 ¹. Following this, product registration, testing, and production will commence, with clinical data from China not being used to establish product standards in the US ¹. The company also intends to enter the European market in January 2026, conducting localized management and operations and initiating localized registration of its IVD products in Europe in 2026 ¹.

Another key growth vector is the advancement of its lung cancer early screening product, A+LCGuard. This Class III medical device requires clinical trials before registration ¹. The company plans to begin A+LCGuard's clinical research in November 2025, with completion anticipated within six months of that date ¹. The clinical research protocol is expected to pass ethical review and receive ethics committee approval by the end of October 2025 ¹. The results of this clinical research will inform the work plan for future large-scale clinical trials, with the registration declaration expected after the completion of these trials ¹. The company anticipates obtaining the required registration certificate for A+LCGuard by October 2027 ¹.

Operationally, the company expects to continue investing in research and development and managing its cost structure. Research and development expenses are projected to increase due to ongoing clinical development activities, particularly with the planned clinical research for A+LCGuard ¹. The company's quality control system, which includes quality manuals, procedure documents, and quality records, will continue to be implemented and improved to ensure product quality and regulatory compliance throughout procurement, production, and realization processes ¹. The company's R&D personnel are crucial for biochip design, production, system development, and medical testing instrument design, and will also be responsible for training clinical laboratory and production line personnel ¹.

Regarding capital allocation, Advanced Biomed aims to fund its working capital and liquidity requirements through cash generated from operations, banking facilities, and equity and debt financings ¹. The company completed an initial public offering in 2025, raising gross proceeds of $6.56 million ¹. Additionally, on June 6, 2025, it entered into an ELOC Agreement to issue and sell up to $25,000,000 of common stock to HELENA GLOBAL INVESTMENT OPPORTUNITIES I LTD. ¹. The company's existing cash balance of $2,903,915 as of June 30, 2025, is believed to be sufficient to cover research and development and operating expenditures for a minimum of approximately twelve months from the report date ¹. The company's contractual obligations for operating lease commitments total $41,690, with $35,811 due in less than 1 year and $5,879 due in 1-3 years ¹.

The company explicitly flags several structural headwinds and execution risks. The cancer early detection market is characterized by rapid changes, including technological and scientific breakthroughs, frequent introductions of new tests, and evolving industry standards, requiring continuous product upgrades and new launches ¹. There is no assurance that these efforts will be successful or yield a return on investment ¹. The company also faces risks related to the lengthy and complex product development process, including potential failures in demonstrating clinical utility, delays in regulatory approvals, and non-compliance by third-party investigators or CROs ¹. Furthermore, the company has not yet conducted any clinical trials for its products, and uncertainties or failures in these trials could materially and adversely affect its business ¹. The reliance on third parties for manufacturing, supply, and registration applications in China also presents risks of limited or interrupted supply, or unsatisfactory quality and quantity ¹.

Geographic, regulatory, and macro factors are significant constraints. The company's products must obtain regulatory approvals from the NMPA in China, and similar clearances from other jurisdictions like the FDA in the U.S. and CE marking in Europe are required for international expansion ¹. There is no guarantee that these approvals will be obtained on time or at all, and clinical data from China will not be used for US product standards ¹. The company's products are not currently covered by any national or provincial medical insurance programs in China, and there is no guarantee that its application for A+LCGuard coverage will be approved, which could reduce consumer interest ¹. The unique political status of Taiwan and geopolitical tension with China could negatively affect the business, especially given the reliance on Advanced Biomed Taiwan for R&D ¹. Taiwan's foreign exchange controls and restrictions on dividend payments from its subsidiary could also impact liquidity ¹. Additionally, the Chinese government's significant oversight and potential intervention in business operations, as well as uncertainties in the interpretation and enforcement of PRC laws and regulations, pose risks to the company's ability to operate profitably and transfer funds ¹.

Advanced Biomed faces substantial risks across macroeconomic, competitive, regulatory, geopolitical, and operational domains. Macroeconomic risks include the potential for a prolonged slowdown in the global or Chinese economy, which could negatively impact client confidence and demand for the company's products ¹. Inflation, particularly in Taiwan, could increase operating costs such as employee compensation and R&D charges, exacerbated by an acute workforce shortage creating a competitive wage environment ¹. Operationally, the company is an early-stage diagnostics company with a limited operating history and no revenue-generating products, making future performance highly uncertain ¹. There is a significant risk that the company may fail to develop or commercialize its early cancer detection devices, chips, or kits on time or at all, with product candidates potentially failing to demonstrate clinical utility or facing negative or inconclusive results in development ¹. Disruptions at production sites, regulatory compliance issues, or cybersecurity breaches could delay commercialization, raise costs, or harm the company's reputation ¹. The manufacturing and testing process is complex and subject to strict quality control, with risks of equipment failure, non-compliance, raw material issues, software issues, sample contamination, or human error, which could lead to product defects, recalls, or liability ¹. The company also faces security threats to its information technology infrastructure and unauthorized use of data, which could expose it to liability or damage its reputation ¹.

Competitively, the cancer early detection and screening market is highly competitive, with existing and potential future competitors potentially possessing greater financial, technological, R&D resources, and marketing capabilities, enabling them to respond more quickly to market changes or adopt more aggressive pricing ¹. The company's future success depends on its ability to keep pace with rapid technological and scientific breakthroughs and to effectively promote its brand and protect its reputation, which could be harmed by negative publicity or product failures ¹. The company also has limited experience in product promotion and sales, which could hinder successful commercialization ¹.

Regulatory risks are pervasive, particularly in China, where a comprehensive regulatory framework for the cancer screening industry is still developing, leading to uncertainties in compliance and potential adverse effects from new laws or interpretations ¹. Obtaining and maintaining necessary regulatory approvals, licenses, and registrations from the NMPA in China, and from authorities like the FDA in the U.S. and for CE marking in Europe, is a long, expensive, and uncertain process, with no guarantee of success or timely approval ¹. For instance, A+LCGuard, a Class III medical device, requires clinical trials, and delays in ethical approval or participant recruitment could postpone its launch ¹. Post-approval, products are subject to ongoing regulatory obligations and scrutiny, with potential for significant additional expenses, restrictions, or even withdrawal of marketing approval if compliance is not maintained ¹. Furthermore, there is no guarantee that the company's products will be covered by the National Medical Insurance Program in China, which could significantly impact market acceptance and sales ¹.

Geopolitical risks are notable, especially due to the unique political status of Taiwan and its tensions with China, which could negatively affect the company's business and the value of investments ¹. Taiwan's foreign exchange controls and restrictions on dividend payments from its subsidiary could limit the company's ability to satisfy liquidity requirements ¹. The Chinese government's significant oversight and potential intervention in business operations, including new policies affecting industries or foreign investment, could materially change operations or reduce the value of securities ¹. Uncertainties in the interpretation and enforcement of PRC laws and regulations, including those related to cybersecurity, data protection, and M&A, could limit legal protections and impact business operations ¹.

Finally, financial risks include having incurred net losses of $3,258,969 in 2025 and $2,782,278 in 2024, along with significant negative cash flows from operating activities of $5,825,055 in 2025 and $2,126,340 in 2024, raising substantial doubt about the company's ability to continue as a going concern ¹. The company requires substantial additional funding for operations, commercialization, and expansion, and there is no assurance that such financing will be available on acceptable terms or at all, potentially leading to dilution of existing shareholders ¹.

Management's message to shareholders conveys a commitment to advancing precision oncology detection solutions despite the company's early stage of commercialization and current lack of revenue-generating products. The company explicitly states its expectation of being in a state of continuous loss for the next two to three years ¹. Management emphasizes its focus on the integration of interdisciplinary technologies and its microfluidic technology platform for early cancer screening, detection, diagnosis, staging, and treatment assistance ¹. Key strategic priorities include increasing market penetration of oncology auxiliary products and expanding the product portfolio to actively focus on in vitro early diagnosis, rapid evaluation of chemotherapy drugs, individualized treatment, detection of drug resistance, and monitoring of tumor recurrences ¹. Another priority is to develop the cancer screening market in China and further expand into North American and European markets by establishing subsidiaries and localizing production and operations ¹. Lastly, management is committed to expanding R&D to strengthen and develop pipeline products, actively promoting the research, development, application, and registration of other cancer early screening products ¹. The company's existing cash of $2,903,915 as of June 30, 2025, is projected to be sufficient to meet research and development and operating expenditures for a minimum period of approximately twelve months from the date of the report ¹.