F-1: YD Bio Completes Merger, Advances Cancer & Eye Therapies

YD Bio Limited has completed its business combination, becoming a publicly traded biopharmaceutical company focused on cancer detection and eye disease treatments, despite reporting a pro forma net loss of $10.5 million for 2024.

Summary

• YD Bio Limited completed a business combination on August 28, 2025, with Breeze Holdings Acquisition Corp. and YD Biopharma Limited, resulting in Breeze and YD Biopharma becoming wholly-owned subsidiaries of YD Bio.
• The company is now a biopharmaceutical entity specializing in blood-based cancer detection and the development of stem celland exosome-based therapeutics, in addition to supplying clinical testing drugs.
• For the year ended December 31, 2024, YD Biopharma (the operating subsidiary) reported net revenue of $510,360, a gross profit of $155,356, and a net loss of $1,411,559.
• Pro forma combined financial information for the year ended December 31, 2024, shows a net loss of $10,548,000, reflecting significant transaction costs of approximately $6.2 million.
• YD Bio raised $13.2 million in PIPE financing at $8.00 per share, which will be used for working capital and general corporate purposes.
• The company holds exclusive licenses for DNA methylation analysis technology from EG BioMed for pancreatic and breast cancer detection, and patented technology from 3D Global Biotech Inc. for dry eye disease, glaucoma, and corneal repair treatments.
• A Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens product, licensed from 3D Global, has already received 510(k) clearance from the FDA (K213119) on May 13, 2022.
• The FDA de novo application for the breast cancer monitoring blood test was withdrawn by EG BioMed following regulatory feedback and a March 2025 court ruling on Laboratory Developed Tests (LDTs); a new pre-submission is targeted for the end of 2025.
• EG BioMed's U.S. laboratory, established in February 2025, obtained a Washington State Medical Test Site (MTS) license (CLIA#:50D2316600) and finalized CAP accreditation in July 2025, allowing it to market pancreatic cancer blood tests as HCP LDTs.
• Both YD Bio Limited and Breeze Holdings Acquisition Corp. have expressed substantial doubt about their ability to continue as a going concern, primarily due to the need for additional funding and the uncertainties surrounding the business combination and future operations.

Sentiment

Score: 4

Explanation: The sentiment is moderately negative due to significant pro forma net losses, explicit 'going concern' warnings for both the parent and SPAC entities, and regulatory delays for key cancer detection products. While there are strong strategic partnerships, promising technology, and large target markets, the immediate financial challenges and regulatory hurdles present substantial risks and uncertainties for investors.

Positives

• Completed a significant business combination, establishing YD Bio as a publicly traded biopharmaceutical company.
• Possesses exclusive, multi-decade licensing agreements for advanced DNA methylation analysis technology for cancer detection and stem cell/exosome-based therapies for eye diseases.
• Has established strategic partnerships with global pharmaceutical companies like Novartis and Alcon, serving as a clinical testing drug supplier.
• The Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens product has already secured FDA 510(k) clearance, indicating a commercialized product in the eye care market.
• Pancreatic cancer detection technology shows high sensitivity (93.8% in stages I/II, 100% in stages III/IV) and specificity (92.9%) in EG BioMed's studies.
• Breast cancer detection technology demonstrated high accuracy (97.0% pilot, 95.4% validation), sensitivity (81.8% pilot, 89.2% validation), and specificity (99.3% pilot, 96.9% validation) in studies.
• Management team comprises seasoned biomedical experts with over 30 years of experience, including Chairman Dr. Ethan Shen and Chief R&D Officer Dr. Ruo-Kai Lin.
• Operates in large and underserved markets, with the global cancer diagnostics market projected to reach $178.26 billion by 2033 and the dry eye syndrome market $13.0 billion by 2032.
• Secured $13.2 million in PIPE financing, providing capital for working capital and general corporate purposes.

Negatives

• YD Biopharma reported a net loss of $1,411,559 for the year ended December 31, 2024, compared to a net income of $13,560 in 2023, indicating a significant decline in profitability.
• Pro forma combined net loss for 2024 was $10,548,000, largely due to transaction costs associated with the business combination.
• Both YD Bio Limited and Breeze Holdings Acquisition Corp. have substantial doubt about their ability to continue as a going concern, highlighting significant financial instability.
• The company is highly dependent on license agreements with EG BioMed and 3D Global Biotech Inc., with termination of these agreements posing a threat to commercialization and equity value.
• No FDA clearance or approval has yet been obtained for any of the cancer screening test products, and the de novo application for breast cancer was withdrawn, delaying market entry.
• The increase in cost of revenue (80%) outpaced net revenue growth (46%) in 2024, primarily due to a shift to lower-margin products.
• Significant increases in operating expenses, including professional and consultancy fees ($0.6 million), R&D expenses ($0.5 million), and staff costs ($0.1 million), contributed to the net loss.
• Cannot predict when or if warrants will be exercised, meaning the company may not receive the maximum gross proceeds of $62,387,500 from cash exercise of warrants.
• The company faces intense competition from well-financed multinational diagnostic and pharmaceutical companies with greater resources and established market presence.

Risks

• High dependence on license agreements with EG BioMed Co., Ltd. and 3D Global Biotech Inc.; termination or disputes could prevent product commercialization and significantly impact equity value.
• Market size estimates for current and future products may be smaller than anticipated, impairing sales growth.
• Reliance on third-party suppliers for manufacturing, with potential for delays or increased costs if suppliers fail to meet demands or cease providing components.
• Need for significant additional funding to implement business plans and respond to opportunities or unforeseen circumstances, with no assurance of securing such financing on favorable terms or at all.
• Clinical testing of product candidates may not yield successful results, preventing commercialization and leading to abandonment of projects.
• Substantial litigation costs may be incurred to protect intellectual property, and inability to protect IP could lead to loss of competitive advantage or infringement claims.
• Failure to comply with extensive and frequently changing regulations in the pharmaceutical/medical device industries could result in fines, penalties, or suspension of business activities.
• Future success depends on the ability to develop new products and technologies and maintain facilities to meet customer needs in rapidly changing markets.
• Failure of information technology systems or cyber-attacks could materially adversely affect business, reputation, financial condition, or results of operations.
• Success is highly dependent on certain key personnel, including product development and engineering staff; loss of such personnel could delay product development and disrupt business.
• Growth relies on broad market acceptance of product offerings, which is not assured, especially if competitors offer preferred products.
• Loss of sales or significant reductions in orders from major customers (e.g., Alcon and Novartis, accounting for 54.7% of 2024 revenue) could materially adversely affect the business.
• The PCAOB's historical inability to inspect the company's auditor in Hong Kong, and potential future inability, could lead to delisting of common stock under the HFCAA.
• Recent reductions in force across the U.S. federal government may impact the ability to secure necessary meetings, guidance, clearances, or approvals from the FDA.
• Securing FDA clearance or approval is a complex, time-consuming, and expensive process with no assurance of success, potentially leading to significant delays or denial.
• Modifications to cleared or approved products may require new clearances or approvals, or necessitate ceasing marketing or recalling modified products.
• Clinical trials are expensive, time-consuming, and uncertain, with risks of delays, failures, or adverse side effects, which could prevent or delay commercialization.
• Products may cause serious adverse side effects or death, leading to regulatory actions, recalls, product liability claims, and reputational damage.
• Compliance with HIPAA security, privacy, and breach notification regulations may increase costs and expose the company to fines or penalties for wrongful use or disclosure of PHI.
• Employees, contractors, and partners may engage in misconduct or improper activities, leading to fraud, abuse, or non-compliance with regulatory standards.
• Negative developments in the field of exosomes could damage public perception of product candidates and affect the ability to obtain regulatory approvals.
• Political considerations relating to Taiwan, including strained relations with the PRC, could adversely affect financial condition and results of operations.
• Imposition of foreign exchange restrictions by Taiwan could adversely affect the company's ability to repatriate dividends.
• Natural disasters and other events outside of control in Taiwan could seriously disrupt business operations.
• Difficulties in enforcing foreign court judgments in Taiwan.
• Currency fluctuations and restrictions on currency exchange may adversely affect the business, including limiting the ability to convert New Taiwan Dollars (NTD) into foreign currencies.
• Uncertainties about the trade war between the United States and Mainland China may materially and adversely affect results of operations.
• As an emerging growth company, YD Bio takes advantage of certain exemptions from reporting requirements, which may make its shares less attractive to some investors.
• No current plans to pay cash dividends, meaning investors may not receive a return unless shares are sold for a price greater than paid.
• Potential for securities litigation, which is expensive and could divert management attention.
• If YD Bio ceases to qualify as a foreign private issuer, it would incur significant additional legal, accounting, and other expenses.
• As a controlled company under Nasdaq rules, YD Bio may be exempt from certain corporate governance requirements, potentially offering less protection to public shareholders.
• Unanticipated changes in effective tax rates or adverse outcomes from tax examinations could adversely affect financial condition and results of operations.
• The IRS may not agree that YD Bio should be treated as a non-U.S. corporation for U.S. federal income tax purposes, leading to substantial U.S. tax liability.
• U.S. Holders may be required to recognize gain on the exchange of shares due to Section 367(a) of the Code.
• If YD Bio were a passive foreign investment company (PFIC), U.S. Holders could be subject to adverse U.S. federal income tax consequences.

Future Outlook

YD Bio's vision is to bring early cancer detection to the world, providing more treatment options. The company plans to achieve this through new product development, acquisitions, licensing, intellectual property expansion, and investments in manufacturing equipment. It intends to continuously increase the market value of its IP 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. A streamlined access model for LDTs, integrating an online portal with a telehealth physician network, is planned for the next twelve months. Phase I-III clinical trials for LSC Eye Drops (Exosomes) and LSC Eye Drug/Injection are anticipated to be completed between 2027 and 2032.

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.
• For EG BioMed, Chief R&D Officer Dr. Ruo-Kai Lin contributes over 30 years of specialized experience in cancer screening.
• 3D Global Biotech is guided by Chairman and Chief Scientific Officer Dr. Ken Ou, a distinguished professional with over 30 years of experience and a former Dean at Taipei Medical University.
• While we have not yet obtained FDA clearance or approval for any of our cancer screening test products, by leveraging translational medicine expertise of our management team, we accelerate the journey from research to clinical trials, positioning YD Bio as a potential leader in the industry.
• 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.
• YD Bio intends to continue increasing the market value of its intellectual property portfolio to support licensure of all its products globally.

Industry Context

YD Bio operates in the highly competitive and rapidly evolving biotechnology and pharmaceutical/medical device industries. The global cancer diagnostics market is valued at $106.32 billion in 2024, projected to reach $178.26 billion by 2033, driven by rising cancer prevalence, advancements in early detection technologies (AI, liquid biopsy), and expanding screening programs. The pancreatic cancer diagnostics market is expected to grow to $4.7 billion by 2030, and the breast cancer diagnostics market to $3 billion by 2033 in the U.S., fueled by increasing incidence and demand for early detection. The contact lens market is projected to reach $26.5 billion by 2033, and the glaucoma treatment market $8.5 billion by 2033. The dry eye syndrome market is expected to grow to $13.0 billion by 2032. YD Bio aims to leverage its non-invasive, cost-effective DNA methylation technology and exosome-based therapies to capture market share in these growing, yet competitive, sectors. The company's strategy of developing partnerships with biopharmaceutical companies aligns with industry trends towards collaborative innovation.

Comparison to Industry Standards

• YD Bio's licensed DNA methylation analysis technology for cancer detection aims to offer advantages over conventional next-generation sequencing (NGS) technologies by focusing exclusively on critical epigenomic markers, potentially being faster, more cost-effective, and widely accessible.
• For breast cancer monitoring, YD Bio's combined detection of methylated GCM2 and TMEM240 significantly outperformed traditional biomarkers like CA-153 and CEA, which have lower sensitivity (60%-70% for CA-153 alone, less than 50% for combined CA-153 and CEA in YD Bio's unpublished data).
• Current FDA-approved cancer tests, such as Guardant360 and Shield, also require Healthcare Provider (HCP) involvement to initiate testing, even on consumer-facing platforms, aligning with YD Bio's intention not to offer fully Direct-to-Consumer (DTC) products for cancer screening.
• No exosome-based drugs have obtained market approval in any country to date, positioning YD Bio's LSC Eye Drops (Exosomes) and LSC Eye Drug/Injection as novel therapies in an unproven field, facing the challenge of being first to market with regulatory approval.
• YD Bio's limbal stem cell-derived exosome products are differentiated by leveraging naturally secreted cell products from a stable limbal stem cell bank, aiming for consistent bioactivity compared to competitors using engineered or ex vivo modified exosomes.

Corporate Governance

Legal Proceedings

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

Related Party Transactions

• YD Bio is highly dependent on license agreements with EG BioMed Co., Ltd. and 3D Global Biotech Inc., where Dr. Ethan Shen, CEO and Chairman of YD Bio, holds significant equity interests (45.34% in EG BioMed and 14.97% in 3D Global).
• Under the EG BioMed License Agreements, YD Bio is obligated to pay a 7% and 20% product royalty on total sales revenue for pancreatic and breast cancer detection technologies, respectively, plus patent application and maintenance fees.
• Under the 3D Global License Agreement, YD Bio is obligated to make up to $4.0 million in milestone payments and quarterly royalty payments of 10% of total sales revenue for certain eye disease products.
• Breeze Holdings Acquisition Corp. (now a subsidiary of YD Bio) had various related party transactions with its Sponsor, including loans for working capital and extension funds, and an administrative support agreement for $5,000 per month.
• The Sponsor agreed to waive its right to be repaid for loans from the Trust Account if Breeze failed to complete a business combination.
• Breeze Holdings paid I-Bankers Securities, Inc. a fee of $3,162,500 (part cash, part YD Bio ordinary shares) upon the consummation of the Business Combination for marketing services.
• Breeze Holdings paid Woolery & Co. a fee of $800,000 (with Sponsor assuming $1.2 million of the obligation) for strategic legal advisory services upon the completion of the Business Combination.
• YD Biopharma had an operating lease arrangement with Chencheng Pei-hu Pharmacy, a company owned by a former director and current shareholder, Mr. Wu.

Stakeholder Impact

• Shareholders face significant dilution risk from potential future equity raises and uncertainty regarding returns due to no planned cash dividends and the company's 'going concern' status.
• Employees may benefit from planned workforce expansion, including hiring senior scientists and a lab manager, but also face risks associated with the company's financial stability and market acceptance.
• Customers (HCPs, pharmaceutical companies) could benefit from new cancer detection and eye treatment products, but face potential delays in product availability due to regulatory hurdles and clinical trial timelines.
• Suppliers and creditors face risks related to the company's financial health and ability to meet obligations, especially given the 'going concern' warnings.
• Regulatory bodies will continue to oversee the company's compliance with complex and evolving healthcare laws, particularly regarding LDTs and medical device approvals.

Next Steps

• Pilot a streamlined access model for Laboratory Developed Tests (LDTs) within the next twelve months, allowing patients to initiate testing through an online portal integrated with an independent telehealth physician network.
• EG BioMed will revise the study design for the breast cancer monitoring blood test and submit a comprehensive study plan for pre-submission review to the FDA by the end of 2025.
• EG BioMed intends to file a formal request for a pre-submission meeting with the FDA for its pancreatic cancer blood test in Q4 2025 to obtain feedback on the proposed regulatory pathway and clinical trial design.
• 3D Global will file a Drug Master File (DMF) with the FDA for the Active Pharmaceutical Ingredient (API) of 3D LensMate Artificial Tears Eye Drops (Exosomes) in Q4 2025.
• Phase I clinical trials for LSC Eye Drops (Exosomes) and LSC Eye Drug/Injection are anticipated to be completed in 2027, followed by Phase II in 2029 and Phase III in 2032.
• Applications for Medicare/Medicaid and CPT-code/Z-code reimbursement for cfDNA methylation testing services are scheduled for 2026, with required documentation preparation ongoing.
• The company plans to establish a state-of-the-art laboratory and hire five senior scientists and a lab manager over the next year to advance research and development efforts.

Key Dates

Recommendation

The company presents a high-risk, high-reward profile. While the completion of the business combination, strategic partnerships, and innovative technologies in large, underserved markets offer significant long-term potential, the immediate financial challenges, including a substantial pro forma net loss and 'going concern' warnings, cannot be overlooked. Regulatory delays for key cancer detection products add to the uncertainty. A 'hold' recommendation is appropriate for seasoned investors who are comfortable with high volatility and long investment horizons, allowing time for the company to navigate regulatory pathways, demonstrate commercial viability of its pipeline, and improve its financial stability. New investors should approach with caution, awaiting clearer signs of operational execution and financial improvement.

Keywords

Biopharmaceutical, Cancer Detection, Exosome Therapy, Stem Cell Therapy, SEC Filing, F-1, Nasdaq, YDES, DNA Methylation, Pancreatic Cancer, Breast Cancer, Dry Eye Disease, Glaucoma, Corneal Repair, Medical Devices, Clinical Trials, FDA Approval, LDTs, Biotech, Taiwan, Merger, SPAC, Going Concern, Intellectual Property, Regulatory Risk, Healthcare