F-1/A: YD Bio Amends F-1 for Biopharma Public Offering

YD Bio Limited filed an F-1/A amendment detailing its business combination, a PIPE financing, and its strategic focus on cancer detection and eye disease therapeutics.

Summary

• YD Bio Limited completed a business combination with Breeze Holdings Acquisition Corp. and YD Biopharma Limited on August 28, 2025, making both wholly-owned subsidiaries.
• The company secured $13.2 million in gross proceeds from a Private Investment in Public Equity (PIPE) financing, issuing 1,650,000 ordinary shares at $8.00 per share.
• YD Bio is a biopharmaceutical company specializing in blood-based cancer detection and the development of stem celland exosome-based therapeutics, also serving as a clinical testing drug supplier.
• The company holds exclusive licenses for DNA methylation analysis technology for pancreatic and breast cancer detection from EG BioMed, and patented technology for dry eye disease, glaucoma, and corneal repair from 3D Global Biotech Inc.
• For the six months ended June 30, 2025, YD Biopharma reported a net loss of $1.9 million, an increase from $0.17 million for the same period in 2024, primarily due to increased general and administrative and R&D expenses.
• Revenue for YD Biopharma decreased by 9% to $204,007 for the six months ended June 30, 2025, compared to $224,980 for the same period in 2024, mainly due to a change in product mix.
• The company's Ordinary Shares are listed on the Nasdaq Global Market under the symbol YDES, with a last sale price of $17.51 per share on October 22, 2025.
• Outstanding Public Warrants and Private Warrants totaling 16,925,000 Ordinary Shares will become exercisable, potentially generating up to $194,637,500 if all are exercised in cash.
• EG BioMed withdrew its FDA de novo application for its breast cancer monitoring blood test and plans a new pre-submission by the end of 2025, following FDA feedback on clinical trial design and sample validation.

Sentiment

Score: 4

Explanation: While the company has made strategic progress with its business combination, PIPE financing, and promising early clinical data for its cancer detection technologies, significant net losses, revenue decline, and regulatory delays for key products indicate substantial operational and financial challenges. The long development timelines for eye disease treatments and the ongoing need for additional capital contribute to a cautious outlook, despite the large market potential.

Positives

• Completed a significant business combination with Breeze Holdings Acquisition Corp. and YD Biopharma Limited, consolidating operations and expanding market reach.
• Successfully raised $13.2 million through a PIPE financing, providing capital for business operations and expansion.
• Possesses exclusive, multi-decade licensing agreements for proprietary DNA methylation analysis technology for pancreatic and breast cancer detection, and stem cell/exosome-based therapeutics for eye diseases.
• Leverages a strong management team with deep expertise in translational medicine, new drug development, and financial management, including Dr. Ethan Shen (30+ years), Dr. Benjamin Zhang (8+ years), Dr. Ruo-Kai Lin (30+ years), and Dr. Ken Ou (30+ years).
• Identified large and underserved global markets for its cancer detection and eye disease treatment solutions, with projected multi-billion-dollar market sizes and significant CAGR.
• Established strategic partnerships with global pharmaceutical companies like Novartis and Alcon as a clinical testing drug supplier, validating its capabilities.
• EG BioMed's U.S. laboratory has obtained a Washington State Medical Test Site (MTS) license and CLIA Certificate No. 50D2316600, enabling high complexity testing.
• Pancreatic cancer detection technology shows high sensitivity (93.8% in stages I/II, 100% in stages III/IV) and specificity (92.9%) based on EG BioMed's studies.
• Breast cancer detection technology demonstrated high accuracy (97.0% in pilot, 95.4% in validation), sensitivity (81.8% pilot, 89.2% validation), and specificity (99.3% pilot, 96.9% validation) in clinical studies.
• The Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens has already received 510(k) clearance from the FDA (K213119) and multiple international certifications (CE, Japan, China, Taiwan).

Negatives

• YD Biopharma reported a net loss of $1.9 million for the six months ended June 30, 2025, significantly higher than the $0.17 million loss in the prior year period.
• Revenue for YD Biopharma decreased by 9% to $204,007 for the six months ended June 30, 2025, compared to $224,980 for the same period in 2024.
• The company is highly dependent on license agreements with EG BioMed and 3D Global Biotech Inc., with termination clauses that could severely impact commercialization and equity value.
• Significant obligations under license agreements include quarterly royalty payments (7% and 20% of sales revenue to EG BioMed, 10% to 3D Global) and milestone payments (up to $4.0 million to 3D Global), which could reduce cash flow and profits.
• No FDA clearance or approval has been obtained for any cancer screening test products, and the process is described as onerous, expensive, and time-intensive.
• EG BioMed withdrew its FDA de novo application for breast cancer monitoring blood test and is targeting a new pre-submission by the end of 2025, indicating delays in regulatory approval.
• The company has limited direct experience in large-scale product manufacturing and expects to rely on third-party manufacturers, which may lead to delays or difficulties.
• The success of new products is speculative and risky, with no guarantee of achieving desired results in clinical studies or market acceptance.
• The company's business will continue to require substantial expenditures before profits, if any, are realized, and it expects significant negative cash flow and operating losses.
• The company may need additional funding to implement its business plan and respond to unforeseen circumstances, with no current commitments for such financing.
• The PCAOB historically could not inspect the company's auditor in Hong Kong, and future inability could lead to delisting under the HFCAA, materially affecting investment value.
• Recent U.S. federal government reductions in force, particularly at the FDA, may impact the ability to secure necessary meetings, guidance, clearances, or approvals for products.
• The company faces intense competition in the biotechnology and pharmaceutical/medical device industries from well-financed companies with greater resources.
• Negative developments in the field of exosomes could damage public perception and adversely affect the ability to obtain regulatory approvals for exosome-based product candidates.
• The company's major subsidiary is based in Taiwan, exposing it to political considerations, foreign exchange restrictions, and natural disaster risks related to the region.
• Management team has limited experience managing a public company, which could lead to increased costs and diversion of attention from day-to-day business.

Risks

• High dependence on license agreements with EG BioMed and 3D Global Biotech Inc.; termination would prevent commercialization and impose significant obligations.
• Market sizes for current and future products are not established with precision and may be smaller than estimated.
• Third-party manufacturers may lack capacity to meet production requirements or clinical testing demands in a timely manner.
• Need for additional funding to implement business plan, which may not be available on acceptable terms or at all, potentially leading to substantial dilution.
• Clinical testing of cancer blood tests or medical products may not yield successful results, preventing commercialization.
• Substantial litigation costs may be incurred to protect intellectual property, and inability to protect IP could lead to loss of competitive advantage.
• Risk of intellectual property infringement claims, causing litigation costs and diverting management attention.
• Failure to comply with regulations related to drug and medical material sales could result in fines, suspension, or termination of business activities.
• Future success depends on ability to develop new products and technologies and maintain facilities to meet customer needs; failure could result in loss of competitive position.
• Failure of information technology systems or cyber-attacks could materially adversely affect business, reputation, financial condition, or results of operations.
• Success depends on certain key personnel, including product development and engineering staff; loss of whom could delay development and disrupt business.
• Growth relies on market acceptance, which is not assured, and competitors may offer preferred products.
• Loss of sales or significant reductions in orders from major customers (e.g., Alcon, Novartis) could have a material adverse effect.
• PCAOB's historical inability to inspect the auditor in Hong Kong deprived investors of inspection benefits, and future inability could lead to delisting under HFCAA.
• Recent reductions in force across the U.S. federal government may impact ability to secure necessary meetings, guidance, clearances, or approvals for products.
• Securing FDA clearance or approval is a complex, time-consuming, and expensive process with no assurance of success, potentially leading to delays or denial.
• Laboratory developed tests (LDTs) may still be subject to FDA regulatory oversight, despite a March 2025 court ruling, potentially requiring regulatory approval or clearance.
• Failure to comply with CLIA regulations for laboratory testing on humans could impede or prevent marketing of HCP LDTs.
• If FDA clearance or approval is required for cancer screening tests, they may be regulated as Class II or even Class III devices, requiring rigorous and lengthy processes.
• Modifications to cleared or approved products may require new clearances or approvals, or lead to cessation of marketing or recalls.
• Clinical trials necessary for regulatory submission are expensive, time-consuming, and uncertain, with potential for delays or failures.
• Results of clinical trials may not support product candidate claims or may reveal adverse side effects.
• Challenges to the validity of informed consent for clinical trials could lead to fines, penalties, litigation, or invalidation of trials.
• Inability to establish and comply with stringent quality standards for tests could lead to adverse patient outcomes, litigation, and negative publicity.
• Ongoing regulatory obligations and review for cleared/approved products may result in significant additional expense and penalties for non-compliance.
• Promotion of unapproved or off-label uses could lead to recalls, fines, penalties, and damage to reputation.
• Non-compliance with complex federal and state healthcare laws and regulations (e.g., Anti-Kickback Statute, FCPA, False Claims Act, HIPAA) could result in substantial penalties.
• Regulations governing pricing and reimbursement vary widely internationally and may adversely affect product commercial success.
• Healthcare reform measures in the U.S. could hinder or prevent commercial success, including potential reductions in Medicare reimbursement rates.
• Products may cause serious adverse side effects or death, delaying or preventing regulatory clearance/approval or leading to negative consequences post-marketing.
• Product recalls could harm reputation, business, and financial results.
• Products may be subject to import alerts by the FDA.
• Medical device or drug reporting regulations for adverse events could result in corrective actions or enforcement actions.
• Product liability lawsuits could cause substantial liabilities and limit commercialization.
• Cybersecurity risks for cyber devices under FDCA, requiring compliance with specific cybersecurity requirements.
• Intense competition in the biotechnology and pharmaceutical/medical device industries from companies with greater resources.
• New cancer detection technologies developed by others could impair ability to maintain and grow business.
• Negative developments in the field of exosomes could damage public perception of product candidates.
• Intellectual property rights may not address all threats to competitive advantage, and changes in patent law could diminish patent value.
• Obtaining and maintaining patent protection depends on compliance with various requirements; non-compliance could reduce or eliminate rights.
• Patent terms may be inadequate to protect competitive position for sufficient time.
• Issued patents could be found invalid or unenforceable if challenged.
• Political considerations relating to Taiwan may adversely affect investment.
• Imposition of foreign exchange restrictions in Taiwan may adversely affect ability to repatriate dividends.
• Natural disasters and other events outside of control in Taiwan may seriously disrupt business operations.
• Difficulty enforcing foreign court judgments in Taiwan.
• Currency fluctuations and restrictions on currency exchange may adversely affect business and reduce revenues/profits in U.S. dollar terms.
• Economic downturn or decline in population growth in Taiwan may materially and adversely affect financial condition.
• Uncertainties about the trade war between the United States and Mainland China may materially and adversely affect results of operations.
• JOBS Act exemptions for emerging growth companies may prevent shareholders from accessing certain information and make shares less attractive.
• Increased legal, accounting, and compliance costs associated with Section 404 of Sarbanes-Oxley Act after ceasing to be an emerging growth company.
• If securities or industry analysts do not publish research or publish negative reports, share price and trading volume could decline.
• No current plans to pay cash dividends, meaning return on investment depends on share price appreciation.
• Subject to securities litigation, which is expensive and could divert management attention.
• Ceasing to qualify as a foreign private issuer would incur significant additional legal, accounting, and other expenses.
• Reliance on Cayman Islands corporate governance standards as a foreign private issuer may provide less protection than U.S. domestic issuers.
• Inability to satisfy Nasdaq listing requirements could lead to delisting, negatively affecting share price and ability to raise capital.
• Public Warrants and Private Warrants becoming exercisable would increase shares eligible for future sales and result in dilution.
• Warrant agreement designates New York courts as exclusive forum, potentially limiting warrant holders' ability to obtain a favorable judicial forum.

Future Outlook

YD Bio's vision is to create a cancer-free world through advancements in biotechnology, focusing on early cancer detection. The company plans to achieve this through new product development, acquisitions, licensing, and investing in manufacturing equipment and processes to compete globally. It intends to increase the market value of its intellectual property portfolio to support global product licensure. The company will focus on product development, continuous improvement of manufacturing equipment, and increasing capacity to meet quality and quantity standards. It also plans to expand its employee base, hiring five senior scientists and a lab manager over the next year to strengthen R&D and operational excellence. For eye disease treatments, Phase I clinical trials for exosome-based eye drops and LSC eye drug/injection are anticipated to be completed in 2027, with Phase II in 2029 and Phase III in 2032. For cancer detection, EG BioMed plans a new pre-submission to the FDA for its breast cancer monitoring test by the end of 2025 and aims to complete the application process for insurance coverage by December 2026.

Management Comments

• "Our management team is driving accelerated research and clinical trials under the leadership of Chairman Dr. Ethan Shen, a seasoned biomedical expert with over 30 years of experience, and Chief Medical Officer Dr. Benjamin Zhang, who brings over eight years of expertise in clinical research."
• "YD Bio's vision is to bring early cancer detection to the world. This provides patients with far more treatment options that can be less invasive versus later stage treatment options."
• "We intend to accomplish this through new product development, acquisitions, licensing, the application of intellectual property unique to the medical industry, and through investing in manufacturing equipment and processes that enable us to compete globally."
• "We are confident in our substantial differentiation due to the exceptional accuracy, specificity, sensitivity, and reproducibility of our licensed technology and expertise."

Industry Context

The U.S. cancer diagnostics market is valued at $41 billion in 2024, projected to reach $59 billion by 2030 (6.4% CAGR), driven by demand for early detection, increased investment, FDA approvals, and expanding reimbursement. The global market is even larger, valued at $106.32 billion in 2024, projected to reach $178.26 billion by 2033 (5.91% CAGR). The global pancreatic cancer diagnostics market was $3.4 billion in 2023, expected to reach $4.7 billion by 2030 (4.8% CAGR). The global breast cancer diagnostics market was $4.5 billion in 2023, predicted to expand at a 7.2% CAGR to 2033. The U.S. contact lenses market is projected to grow to $9.2 billion by 2032 (3.8% CAGR), and the global glaucoma treatment market to $8.5 billion by 2033 (3.3% CAGR). The global dry eye syndrome market was $7.0 billion in 2023, projected to reach $13.0 billion by 2032 (7.1% CAGR). YD Bio operates in these growing markets, leveraging non-invasive cfDNA methylation technology and exosome-based therapies, which are novel and unproven, with no exosome therapeutic approved to date. The company faces intense competition from major multinational diagnostic and pharmaceutical companies, specialized biotechnology firms, and research institutions.

Comparison to Industry Standards

• YD Bio's pancreatic cancer detection assay achieved a sensitivity of 93.8% in stages I and II, 100% in stages III and IV, and a specificity of 92.9%, demonstrating strong diagnostic reliability.
• The breast cancer detection test demonstrated an accuracy of 95.4%, sensitivity of 89.2%, and specificity of 96.9% in a validation cohort, significantly outperforming traditional biomarkers like CA-153 (60%-70% sensitivity) and CEA (less than 50% sensitivity when used simultaneously with CA-153).
• Current FDA-approved cancer tests, such as Guardant360 and Shield, also require HCP involvement to initiate testing, aligning with YD Bio's intended model for its cancer screening tests.
• The company's licensed technology for cancer detection aims to overcome limitations of conventional next-generation sequencing (NGS) technologies by focusing on critical epigenomic markers, potentially offering faster and more cost-effective solutions.
• The Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens has received 510(k) clearance from the FDA, indicating substantial equivalence to a legally marketed predicate device, and holds multiple international certifications (CE, Japan, China, Taiwan medical device certificates, ISO 13485, QMS certification).

Management Changes

Corporate Governance

Legal Proceedings

• Neither the company nor any of its subsidiaries is currently a party to any legal proceeding that, individually or in the aggregate, is material to the company as a whole.

Related Party Transactions

• Dr. Ethan Shen, CEO and Chairman, owns approximately 14.97% of 3D Global Biotech Inc. and 45.34% of EG BioMed Co., Ltd. (through EG Biomed (Cayman)), both of which have licensing agreements with YD Bio.
• YD Biopharma entered into an exclusive licensed patent and know-how agreement with 3D Global Biotech Inc. (where Dr. Shen has ownership) for eye disease treatments, with a total consideration of $5,000,000 (including VAT) and ongoing royalty payments of 10% of sales.
• YD Biopharma entered into an exclusive licensed patent and know-how agreement with EG BioMed Co., Ltd. (where Dr. Shen has ownership) for pancreatic cancer detection, with a licensing fee of $1,848,000 and ongoing royalty payments of 7% of sales.
• YD Biopharma entered into an exclusive licensed patent and know-how agreement with EG BioMed for breast cancer detection, with ongoing royalty payments of 20% of sales.
• Breeze Holdings Acquisition Corp. had various related party transactions with its Sponsor (Breeze Sponsor, LLC), including founder shares, private placement warrants, administrative support fees ($5,000/month), and working capital loans (totaling $10,390,465 owed to Sponsor as of June 30, 2025).
• YD Bio Limited (the parent company) had general and administrative expenses paid on its behalf by Breeze, totaling $67,680 as of June 30, 2025.
• YD Biopharma had an operating lease with Chencheng Pei-hu Pharmacy (owned by Mr. Wu, a former director of Yong Ding and current shareholder of YD Bio) from June 2020 to June 2023.
• YD Biopharma had transactions with Chencheng, including purchases and sales of products.
• YD Biopharma has amounts due from affiliates, including $33,636 from 3D Global (prepaid royalty fee) and $32,004 from YC Biotech (prepayment of R&D expenses) as of June 30, 2025.
• YD Biopharma has amounts due to affiliates, including $363 to Chencheng and $18,380 to EG BioMed (R&D expenses payable), and $45,000 to EG Bio USA (service charge for laboratory) as of June 30, 2025.
• A new subscription agreement for PIPE financing was entered into with Ms. Hsiao Lan Wu, who is a Selling Shareholder, replacing Dr. Ou.

Stakeholder Impact

• **Shareholders:** The business combination and PIPE financing could provide growth opportunities, but significant net losses, reliance on licenses, and regulatory delays pose risks to investment value. Dilution from warrant exercises is a potential concern. As a foreign private issuer, shareholders may have less protection than with U.S. domestic issuers.
• **Employees:** The company plans to expand its workforce, including hiring five senior scientists and a lab manager, indicating growth opportunities. However, the intense competition for qualified personnel may lead to increased labor costs.
• **Customers:** The company aims to provide innovative early cancer detection and eye disease treatments, potentially offering better patient outcomes and more treatment options. However, delays in regulatory approvals could impact product availability.
• **Suppliers:** The company relies on third-party suppliers for manufacturing and materials, and the failure of these suppliers could disrupt production. Strategic partnerships with Novartis and Alcon are important for its drug supply business.
• **Creditors:** The company's significant net losses and need for additional funding raise concerns about its ability to meet future obligations, although the PIPE financing is expected to support liquidity in 2025. Loans from the Sponsor to Breeze Holdings were non-interest bearing and repayable upon business combination.

Next Steps

• Pilot a streamlined access model for cancer testing through an online portal integrated with an independent telehealth physician network within the next twelve months.
• EG BioMed to submit a comprehensive study plan for pre-submission review to the FDA for its breast cancer monitoring test by the end of 2025.
• Complete validation of the cfDNA Methylation Assay for the breast blood test by Q4 2025.
• Apply for Medicare/Medicaid and CPT-code/Z-code reimbursement for cfDNA methylation testing services in 2026, with documentation preparation ongoing.
• Complete the application process for insurance coverage by December 2026.
• Initiate applications for clinical trials evaluating the efficacy of exosome-based contact lenses and artificial tears in alleviating dry eye symptoms in 2025.
• Complete Phase I clinical trials for 3D LensMate Eye Drops (Exosomes) and LSC Eye Drug/Injection by 2027.
• Complete Phase II clinical trials for 3D LensMate Eye Drops (Exosomes) and LSC Eye Drug/Injection by 2029.
• Complete Phase III clinical trials for 3D LensMate Eye Drops (Exosomes) and LSC Eye Drug/Injection by 2032.
• Establish a state-of-the-art laboratory and hire five senior scientists and a lab manager over the next year to strengthen R&D capabilities.
• Make installment payments for the pre-sale real estate contract on March 31, 2026, and upon issuance of the use permit with handover by December 30, 2025.

Key Dates

Recommendation

YD Bio Limited has completed a significant business combination and secured a PIPE financing, positioning itself in high-growth biopharmaceutical markets for cancer detection and eye disease treatments. The company boasts strong intellectual property and an experienced management team. However, it faces substantial financial challenges, including significant net losses and a need for additional capital. Regulatory hurdles, such as the withdrawal of an FDA application for a breast cancer test and long clinical trial timelines for eye therapies, introduce considerable uncertainty and potential delays. While the long-term market potential is attractive, the current financial performance and regulatory risks warrant a 'hold' recommendation. Investors should monitor progress on regulatory approvals, clinical trial outcomes, and the company's ability to secure further funding and achieve profitability before considering a stronger position.

Keywords

Biopharmaceutical, Cancer Detection, Stem Cell Therapy, Exosome Therapeutics, SEC Filing, F-1/A, Business Combination, PIPE Financing, DNA Methylation, Pancreatic Cancer, Breast Cancer, Eye Disease Treatment, Contact Lenses, Glaucoma, Dry Eye Syndrome, FDA Approval, Clinical Trials, Regulatory Compliance, Nasdaq, YDES, Taiwan, Corporate Governance, Warrants, Biotech, Diagnostics, Pharmaceuticals