S-1/A: Advanced Biomed Inc. Files Amendment No. 15 to Form S-1 for Proposed Public Offering

Advanced Biomed Inc., a Nevada-based holding company focused on integrating semiconductor technology and biotechnology for cancer diagnostics, has filed Amendment No. 15 to its Form S-1 registration statement for a proposed initial public offering.

Summary

• Advanced Biomed Inc., a Nevada-based holding company, has filed Amendment No. 15 to its Form S-1 registration statement.
• The company is planning an initial primary underwritten public offering of 1,875,000 shares of common stock, with an expected offering price between $4.00 and $6.00 per share.
• Advanced Biomed is seeking to list its Common Stock on the Nasdaq Capital Market under the symbol ADVB.
• The company's operations are primarily conducted through its Taiwan subsidiary, with additional subsidiaries in Hong Kong and Shanghai.
• Advanced Biomed focuses on integrating semiconductor technology and biotechnology to develop rapid and affordable assay products and services for cancer patients.
• The company's products include devices and biochips for early cancer screening, detection, diagnosis, and treatment selection.
• Advanced Biomed has completed research and development for several products, including A+Pre, AC-1000, A+CellScan, A+SCDrop, and the A+LCGuard Lung Cancer Early Screening Kit.
• The company plans to begin clinical research for A+LCGuard by the end of June 2025.
• Advanced Biomed faces legal and operational risks associated with its Shanghai subsidiary and Hong Kong holding company, particularly concerning potential intervention by the Chinese government.
• The company is an emerging growth company and is subject to various risks, including those related to its limited operating history, competition, regulatory approvals, and financial prospects.

Sentiment

Score: 5

Explanation: The document presents a balanced view, highlighting both the opportunities and risks associated with Advanced Biomed's business and the proposed offering. The company's innovative technology and growth potential are tempered by concerns about regulatory hurdles, financial stability, and geopolitical risks.

Positives

• Advanced Biomed has developed a microfluidic technology platform for rapid product development.
• The company's products use pure physical mechanisms (antigen-independent) and can effectively enrich and detect the CTCs with high or low antigen expressions with high viability.
• A+Pre and AC-1000 and their corresponding chips have been cleared by the NMPA.
• The company has a multi-disciplinary management team with experience in semiconductor/integrated circuits and biomedical expertise.

Negatives

• Advanced Biomed has a limited operating history and has not generated positive cash income.
• The company is expected to be in a state of continuous loss for the next two to three years.
• The company faces intense competition in the cancer early detection and screening market.
• The company is subject to unique legal risks, and the enforcement of Chinese laws and regulations can change quickly with little advance notice.

Risks

• The company may be unable to develop or commercialize early cancer detection products and compete with its competitors.
• The company may be adversely affected by uncertainties and changes in China's regulations on the cancer screening industry.
• The company plans to test and manufacture its products and future products around the world and may be subject to various risks related to regulatory schemes, intellectual properties, data privacy.
• The company has not generated positive cash income and any failure to raise additional capital will significantly hinder its ability to continue its operations and developing new products.
• The geopolitical tension between Taiwan and China could negatively affect the company's business and hence the value of your investment.
• The Chinese government may intervene or influence the company's operations at any time or may exert more control over offerings conducted overseas and/or foreign investment in the company.
• You may experience extreme stock price volatility.

Future Outlook

Advanced Biomed expects to be in a state of continuous loss for the next two to three years as it continues to invest in research and development and navigate the regulatory approval process for its products.

Management Comments

• We are committed to the application research of integrating semiconductor technology and biotechnology.
• Through the enrichment, capture, and identification of circulating tumor cells and related tumor marker cells in the field of liquid biopsy, we aim to provide cancer patients with rapid and affordable assay products and services.
• We follow the principle of modularization when design and develop all of our products and equipment so that products and equipment can be produced locally to meet different regulatory requirements.

Industry Context

The announcement highlights Advanced Biomed's participation in the growing liquid biopsy market, which is projected to experience significant growth in the coming years. The company's focus on early cancer detection aligns with industry trends towards less invasive and more accurate diagnostic methods.

Comparison to Industry Standards

• The current market uses positive antibody-labeling selection to capture CTCs out of the blood by a specific epithelial cell adhesion molecule (EpCAM).
• This method could detect tumor cells in the patients blood for diagnosing lung, prostate, pancreatic, and breast cancers.
• However, this technology costs approximately $1,000 per chip, and the processing time per patient is up to 12 hours.
• Besides, antibody-based methods such as immunomagnetic methods are highly dependent on antigen expression of CTC.
• Some CTCs may show low or no EpCAM expression on the cell membrane, and thus cannot be effectively captured using the proposed biomarkers and makes it difficult to detect cancer in the early stage.
• More importantly, the capture of dying or dead CTCs cannot provide meaningful information to doctors for diagnosis or treatment.
• Our products use pure physical mechanisms (antigen-independent) and can effectively enrich and detect the CTCs with high or low antigen expressions with high viability.

Related Party Transactions

• Advanced Biomed Inc.(HK) entered into one unsecured, interest-free loan to Hung To Pau, Ph.D. amounting to US$200,000 for general working capital in July 2024.
• Advanced Biomed Inc.(Taiwan) entered into an unsecured, interest-free loan to Yi Lu amounting to NTD 3,578,212 (approximately US$110,268) for general working capital in January 2023.
• Advanced Biomed Inc.(Taiwan) entered into ten unsecured, interest-free loans to Well Fancy Development Ltd amounting to NTD 2,967,700 (approximately US$91,455), NTD2,989,873 (approximately US$92,138), NTD4,270,200 (approximately US$131,593), NTD1,945,000 (approximately US$59,938), NTD1,858,120 (approximately US$57,261), NTD2,912,200 (approximately US$89,744), NTD2,890,065 (approximately US$89,062), NTD5,857,750 (approximately US$180,516), NTD4,356,145 (approximately US$134,242) and NTD3,732,100 (approximately US$115,011) for general working capital in August 2022, April 2023, May 2023, June 2023, July 2023, August 2023, October 2023, December 2023, February 2024 and April 2024, respectively.
• Shanghai Sglcell Biotech Co., Ltd entered into four unsecured, interest-free loans to Shanghai Junfu Electronic Technology Co., Ltd. amounting to RMB500,000 (approximately US$71,249) in April 2023, May 2023, June 2023 and September 2023, respectively, and RMB700,000 (approximately US$99,749), RMB1,500,000 (approximately US$213,748) and RMB700,000 (approximately US$99,749) in January 2024, March 2024 and June 2024, respectively, for general working capital.

Stakeholder Impact

• Shareholders may experience dilution due to the issuance of new shares in the offering.
• Shareholders may face difficulties enforcing liabilities against the company's directors and officers in China.
• The company's ability to pay dividends may be restricted by PRC laws.
• The company's operations are subject to the effects of a rising rate of inflation.

Next Steps

• Complete the remittance process to Taiwan and Hong Kong.
• Initiate clinical research for A+LCGuard by the end of June 2025.
• Continue the registration application process for A+SCDrop, A+CellScan, A+CellScan Chip, and A+LCGuard.
• Continue the registration review process for the four matching immunostaining kits.
• Pursue expansion into North American and European markets.
• Submit the A+CellScan, and A+CellScan Chips registrations to the NMPA in December 2024 while completing preliminary works for A+SCDrops application.

Key Dates

Keywords

Liquid Biopsy, Cancer Screening, Microfluidic Biochips, Early Cancer Detection, Circulating Tumor Cells, Advanced Biomed, Initial Public Offering, Biotechnology, Medical Devices, Diagnostics