S-1/A: Advanced Biomed Inc. Files Amendment No. 13 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 detection, has filed Amendment No. 13 to its Form S-1 registration statement for a proposed public offering of 1,875,000 shares of common stock.

Summary

• Advanced Biomed Inc., a Nevada-based holding company, has filed Amendment No. 13 to its Form S-1 registration statement.
• The company is planning a public offering of 1,875,000 shares of common stock, with an expected initial public offering price between $4.00 and $6.00 per share.
• Advanced Biomed operates primarily through its Taiwan subsidiary, focusing on microfluidic technology for cancer detection.
• The company has applied to list its Common Stock on the Nasdaq Capital Market under the symbol ADVB.
• The offering includes a resale prospectus for selling shareholders.
• The company faces risks related to Chinese regulations, as its Shanghai subsidiary could be subject to government intervention.
• The company intends to use the net proceeds of approximately $5.27 million (assuming an offering price of $4.00 per share) for clinical research, chip design and development, marketing and sales, and general working capital.
• The underwriters have a 45-day option to purchase up to 281,250 additional shares to cover over-allotments.
• The company will issue warrants to the representative of the underwriters to purchase 112,500 shares of Common Stock (or 129,375 shares of Common Stock if the representative of underwriters exercises its over-allotment option in full) equal to 6% of the shares sold in this offering, at a per share exercise price equal to 125% of the per share offering price.

Sentiment

Score: 5

Explanation: The document presents a mix of positive and negative aspects. The company has innovative technology and growth potential, but also faces significant financial and regulatory challenges. The sentiment is neutral overall.

Positives

• The company has developed a microfluidic technology platform for cancer detection.
• A+Pre and AC-1000 and their corresponding chips have been cleared by the NMPA.
• The company has completed pre-mass production trial tests for A+Pre Chip and AC-1000 Enrichment Chip.
• The company has a multi-disciplinary management team.
• The company has a growth strategy to increase market penetration, expand to other regions, and strengthen R&D.

Negatives

• The company has incurred net losses for the years ended June 30, 2024 and 2023.
• The company has not generated positive cash income.
• The company expects to be in a state of continuous loss for the next two to three years.
• The company has not conducted any clinical trials for its products.
• The company has relatively limited experience in product promotion and sales.

Risks

• The company may be unable to develop or commercialize early cancer detection products and compete with competitors.
• The company may be adversely affected by uncertainties and changes in China's regulations on the cancer screening industry.
• The company may fail 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 may be subject to intellectual property infringement or misappropriation claims by third parties.
• The company may not be able to generate sufficient operating cash flows and working capital to continue as a going concern.
• The company faces economic and political risks associated with doing business in Taiwan, particularly due to the geopolitical tension between Taiwan and China.
• The Chinese government may intervene or influence the company's operations in the Mainland China or Hong Kong at any time or may exert more control over offerings conducted overseas and/or foreign investment in us.
• 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. The company plans to start A+LCGuards clinical research by the end of 2024, which are expected to be completed in the first half of 2025.

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 global liquid biopsy market is projected to grow significantly, with a CAGR of 12.46% from 2023 to 2030, reaching USD22,865.56 million in 2030, according to Grand View Research, Inc.

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), which costs approximately $1,000 per chip, and the processing time per patient is up to 12 hours.
• Universal Diagnostics (UDX) detected 37 lung cancer patients and 71 asymptomatic control subjects with a panel of 10 methylation sites with a sensitivity of 73% and 90% specificity.
• The Aifeiming gene methylation detection kit has a clinical sensitivity of 86.83%.

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$68,802) in April 2023, May 2023, June 2023 and September 2023, respectively, and RMB700,000 (approximately US$96,323), RMB1,500,000 (approximately US$206,407) and RMB700,000 (approximately US$96,323) in January 2024, March 2024 and June 2024, respectively, for general working capital.
• As of June 30, 2024, the amount due to Hung To Pau, Ph.D. of US$1,233,764 has been waived off by Hung To Pau, Ph.D.
• As of June 30, 2024, the total amount due to Well Fancy Development Ltd of US$1,586,860 has been waived off by Well Fancy Development Ltd.

Stakeholder Impact

• Shareholders may experience dilution from the issuance of new shares.
• The company's ability to pay dividends is restricted by PRC and Taiwan regulations.
• The company's success depends on market acceptance of its products by customers, hospitals, and physicians.
• The company's operations are subject to the effects of a rising rate of inflation.

Next Steps

• The company plans to start A+LCGuards clinical research by the end of 2024, which are expected to be completed in the first half of 2025.
• The company expects 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 aims to complete site selection and personnel recruitment in the United States by the end of 2024 and start product registration, testing and production afterward.
• The company plans to break into the European market in 2025 and conduct localized management and operations in accordance with European regulations.
• In 2025, the company plans to begin the localized registration of its IVD products in Europe.

Key Dates

Keywords

cancer detection, microfluidic technology, liquid biopsy, initial public offering, regulatory approvals, clinical trials, precision medicine, biotechnology, medical devices, China