S-1/A: Advanced Biomed Inc. Eyes Nasdaq Listing with $7.5 Million Common Stock Offering

Advanced Biomed Inc., a Nevada-based holding company, plans to raise capital through a $7.5 million common stock offering to fund cancer detection technology development and market expansion.

Summary

• Advanced Biomed Inc. is undertaking a public offering of 1,875,000 shares of common stock, with an expected price range of $4.00 to $6.00 per share, aiming to raise $7.5 million.
• The company intends to use the net proceeds primarily for in vitro diagnostics (IVD) clinical research, chip design and development, facility upgrades, expansion to other markets, marketing and sales, and general working capital.
• Advanced Biomed Inc. operates through its subsidiaries, Advanced Biomed Taiwan and Advanced Biomed HK, focusing on microfluidic technology for early cancer detection.
• The offering includes a 45-day over-allotment option for the underwriters to purchase up to 281,250 additional shares.
• Craft Capital Management LLC is acting as the representative of the underwriters for the offering.
• The company has applied to list its Common Stock on the Nasdaq Capital Market under the symbol ADVB.
• The offering also includes the registration of 1,875,000 shares for resale by selling stockholders, with no proceeds going to the company from these sales.
• Advanced Biomed HK Limited acquired 100% equity interest of Shanghai Sglcell Biotech Co., Ltd. on January 1, 2022.
• The company is subject to risks associated with operating in China, including regulatory changes and potential government intervention.
• The company is also subject to the Holding Foreign Companies Accountable Act (HFCAA) which may result in the delisting of the company or prohibition of trading in our Common stock in the future if the PCAOB is unable to inspect our accounting firm at such future time.

Sentiment

Score: 5

Explanation: The document presents a mix of positive and negative aspects. The company is pursuing growth opportunities and has developed innovative technology, but it also faces significant risks and uncertainties, particularly related to regulatory approvals and operating in China. The sentiment is neutral, reflecting the balanced view.

Positives

• The company has developed a microfluidic technology platform for early cancer detection.
• A+Pre and AC-1000 and their corresponding chips have been cleared by the NMPA.
• The company has a multi-disciplinary management team and R&D team.
• The company has a growth strategy focused on increasing market penetration, expanding to other regions, and strengthening its product pipeline.

Negatives

• The company has a limited operating history and has not generated positive cash income.
• The company is subject to risks associated with government regulations in China and Taiwan.
• The company faces risks related to the manufacture and supply of its products.
• The company may be unable to develop and commercialize its early cancer detection devices, chips or immunochromogenic kits on a timely basis, or at all.
• The company may be adversely affected by uncertainties and changes in China's regulations on the cancer screening industry.
• The company is subject to the Holding Foreign Companies Accountable Act (HFCAA) which may result in the delisting of the company or prohibition of trading in our Common stock in the future if the PCAOB is unable to inspect our accounting firm at such future time.

Risks

• The company may not be able to develop or commercialize early cancer detection products and compete with its competitors.
• The company may be unable to obtain, complete or maintain the required regulatory approvals, licenses, registrations or filings.
• 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 that could negatively affect our business and hence the value of your investment.
• The company, through its Shanghai and Hong Kong subsidiaries, are subject to unique legal risks, and the enforcement of Chinese laws and regulations can change quickly with little advance notice.
• The Chinese government may intervene or influence our operations at any time or may exert more control over offerings conducted overseas and/or foreign investment in us, which could result in a material change in our operations and/or the value of our securities we are registering to offer and/or significantly limit or completely hinder our abilities to offer or continue to offer securities to investors and cause the value of such securities to significantly decline or be worthless.
• You may experience extreme stock price volatility.

Future Outlook

The company expects to be in a state of continuous loss for the next two to three years and plans to expand to North American and European markets.

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.
• We have started the registration process with the NMPA in China for all of our products.
• We are looking for suitable locations in the states of California and Washington for our planned expansion to the North America market.

Industry Context

The document highlights the growing market for early cancer detection and liquid biopsy, referencing a Grand View Research report projecting significant growth in the global liquid biopsy market size.

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.
• Among them, A+Pre is mainly used to reduce the viscosity of blood samples, and AC-1000 is used to complete the separation and enrichment of circulating tumor cells (CTCs) and tumor-related targeted cells in blood samples.
• The A+CellScan is mainly used for fluorescent labeling and automatic scanning judgment of targeted cells while A+SCDrop preserves the original viability of single cells.

Related Party Transactions

• 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 offering and potential future offerings.
• The company's ability to attract and retain employees could be affected by the company's financial performance and regulatory environment.
• Customers may benefit from the development of new and improved cancer detection technologies.
• Suppliers may see increased demand for their products as the company expands its operations.
• Creditors face risks related to the company's ability to repay its debts.

Next Steps

• The company plans to begin A+LCGuards clinical research by the end of June 2025.
• The company plans to submit the A+CellScan, and A+CellScan Chips registrations to the NMPA in December 2024 while completing preliminary works for A+SCDrops application.
• The company plans to expand to North American and European market by setting up subsidiaries and localize production and operation to meet specific market demand and compliance requirements in the relevant market.

Key Dates

Keywords

Common Stock, Offering, Advanced Biomed, Cancer Detection, Microfluidic Technology, Clinical Research, Nasdaq, Biomed, Taiwan, China, IVD