YD Bio Limited Announces Major Milestones and Unveils Robust 2026 Clinical and Commercial Roadmap

Taipei, Taiwan, Jan. 05, 2026 (GLOBE NEWSWIRE) — YD Bio Limited (“YD Bio” or the “Company”) (Nasdaq: YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today announced the successful completion of critical milestones across its core platforms: stem cell therapy & exosome platforms focused on ophthalmology conditions, early cancer detection powered by DNA methylation and next-generation precision diagnostics. The Company also outlined a focused, catalyst-driven strategy for 2026, and plans to transition from platform validation to accelerated asset-level clinical and commercial development, subject to regulatory feedback and resource availability.

“2025 has been a transformative year for YD Bio, as we’ve systematically de-risked our foundational platforms and strategically positioned ourselves for rapid advancement,” said Dr. Ethan Shen, Chairman and CEO of the Company. The Company has completed key CMC activities and filed supporting DMFs intended to facilitate future submissions. The FDA has not approved any product. With these key activities the Company expects to enter a catalyst-rich period through 2027, driven by subsequent regulatory submissions and feedback, additional clinical initiations and their results, and strategic growth across our diverse portfolio which the success and timing remain uncertain.

Accelerating Clinical Development Across Global Programs

• Cell Therapy and Exosome Platform: Manufacturing and Regulatory De-risking Completed

YD Bio has achieved comprehensive Chemistry, Manufacturing, and Controls (CMC) development for its Limbal Stem Cell (LSC) platform and LSC-derived exosome products. This includes successful batch testing and qualification of primary LSC cell sources, establishment of scalable cell expansion and cryopreservation methods, and definition of cell specifications. Furthermore, robust exosome expansion, purification, and potency assay methods have been developed, alongside established exosome specifications. Relevant supporting Standard Operating Procedures (SOPs) are finalized, ensuring manufacturing readiness for Investigational New Drug (IND) applications.

The Company plans to continue strengthening its regulatory foundation. The Company has filed Drug Master Files (DMFs) with the U.S. Food and Drug Administration (FDA) for both Limbal Stem Cells and LSC-derived exosomes. Pending FDA approval, this establishes a reusable regulatory framework that significantly reduces program risk and is expected to streamline future IND filings, subject to ongoing regulatory feedback.

YD BioMed expects to advance two lead ophthalmology programs utilizing its LSC Exosome platform, each supported by targeted regulatory and clinical milestones, which the timing of these milestones remains uncertain and are subject to preclinical results, manufacturing readiness and regulatory feedback.

U.S. FDA Clinical Programs (Ophthalmology – LSC Exosomes)

• Dry Eye Disease (DED) – LSC Exosome Eye Drops
  
  • Expected in 2026: Establishment of a clinical-grade LSC cell bank; and IND submission to the U.S. FDA.
  • Expected in 2027: Initiation of Phase I clinical trial.

• Age-Related Macular Degeneration (AMD) – Intravitreal LSC Exosome Therapy
  
  • Expected in 2026: Completion of preliminary preclinical studies; Initiation and conclusion of efficacy and toxicity studies; and IND submission to the U.S. FDA.
  • Expected in 2027: Entry into first-in-human clinical trials.

Taiwan TFDA Clinical Programs (Exovisse Brand)

• LSC Exosome Eye Drops (Temporary Relief of Dry Eye Symptoms)
  
  • Expected 2026: Initiation of subject enrollment following ongoing TMU IRB review.
  • Ongoing: TFDA application in progress.
  • Clinical Site: Ministry of Health and Welfare Shuang Ho Hospital.
  • Serving as a first-in-human validation to support the planned U.S. FDA IND program.

These targeted timelines reflect the Company’s plan to transition from platform validation to asset-level clinical execution, with multiple value inflection points anticipated over the next 24 months, subject to preclinical results, manufacturing readiness and regulatory feedback.

• Strategic Expansion in Precision Oncology Diagnostics

Through its affiliate EG BioMed, YD Bio operates CLIA- and CAP-certified laboratory services across 46 U.S. states. This platform delivers Laboratory Developed Tests (LDTs) for early detection and monitoring of pancreatic, breast, colorectal, and general gastrointestinal cancers, generating recurring revenue and building critical real-world clinical and molecular datasets.

• The Company plans to pursue additional registration and activation efforts for Maryland (MD), Pennsylvania (PA), Rhode Island (RI), and New Jersey (NJ) in 2026 but timing and success remain uncertain.
• Flagship OkaiDx^™ Pancreatic Cancer Early Detection Program is progressing through an FDA-aligned clinical validation pathway.
  
  • Expected 2026: Completion of patient enrollment, data cleaning, quality control, and preliminary statistical analysis; and the Company intends to submit a FDA Q-Submission to discuss potential Breakthrough Device eligibility; there can be no assurance of any determination.

The Company anticipates that this dual-track approach preserves near-term commercial activity under the LDT framework while pursuing regulatory expansion, subject to FDA approval, to broaden market access and valuation uplift.

• Breast & GI Cancer Program Expansion: The Company plans to establish new clinical collaborations and prepare IRB submissions for next-phase expansion, targeting cohort expansion in 2027 for breast cancer monitoring and continued biomarker model refinement for GI/colorectal cancers, applications pending; timing and scope remain uncertain.
• Asia Market Expansion: The Company expects to establish Asia as its first international growth region; timing and success remain uncertain. This includes centralized testing via its U.S. CLIA/CAP-certified laboratory for Taiwan and Hong Kong, and technology transfer, training, and RUO reagent support for six authorized clinical laboratories in China, ensuring compliance with local biospecimen regulations.

Strengthening Intellectual Property and Scientific Leadership

The Company has significantly strengthened its global intellectual property position, creating a high-barrier IP moat. Breast cancer patents have been issued in 28 countries, and pancreatic cancer IP has been issued in the United States, with additional regional issuances in Europe, Asia, and Australia expected in 2026, applications pending; timing and scope remain uncertain. Colorectal and gastrointestinal cancer portfolios are also advancing toward key regional approvals, supporting long-term licensing, strategic partnerships, and enterprise value growth.

The Company plans to further enhance its scientific visibility and academic leadership through presentations at AACR 2026 on breast, GI, and liver cancer data, alongside the publication of full manuscripts on pancreatic and colorectal cancer early detection and monitoring, the timing and scope of which are uncertain.

Strategic Acquisitions Driving Future Growth

The Company plans to evaluate up to three acquisitions in 2026 to significantly enhance its integrated capabilities and accelerate its growth trajectory, the timing and scope of which remains uncertain. The targeted acquisitions are expected to strengthen the Company’s position in precision medicine, integrating advanced diagnostic and analytical tools to support a comprehensive approach spanning detection, stratification, therapy, and longitudinal monitoring.

Furthermore, the acquisitions are expected to help expand the Company’s advanced cell therapy pipeline and bolster its clinical translation capabilities, potentially bringing late-stage assets into development. Collectively, we expect these strategic moves to accelerate internal clinical execution, shorten development timelines, and fortify global regulatory readiness, particularly for multinational clinical trials across key regions such as the United States and Asia, subject to customary closing conditions, regulatory approvals, and the finalization of definitive agreements. However, the Company cannot be sure that one or all of these acquisitions will be successful and result in the anticipated outcome.

2026 Outlook

The Company plans to pursue IND submissions and clinical initiations beginning in 2026, subject to successful completion of preclinical work, CMC readiness, regulatory feedback, and resource availability; projected timing remains subject to change based on these factors. The Company anticipates multiple near-term inflection points from regulatory filings, clinical initiations, and commercial expansion that together support accelerated value creation through 2027.

No Offer or Solicitation

This press release is for informational purposes only and does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval.

Forward-Looking Statements

This press release contains forward-looking statements, including, among others, statements regarding the Company’s plans and expectations concerning preclinical and clinical development, regulatory interactions and potential designations, IND submissions and initiation and timing of clinical trials, commercial validation and market expansion, intellectual property strategies and potential issuances, acquisitions and their anticipated benefits, and the proposed merger with EG BioMed, including its expected timing, approvals, and potential synergies and platform benefits. Forward-looking statements are based on current expectations, estimates, forecasts, and projections and are not guarantees of future performance. Investors can identify these forward-looking statements by words or phrases such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. Actual results may differ materially due to a variety of factors, including regulatory decisions and feedback; preclinical, clinical, and manufacturing outcomes; trial enrollment rates; payer, provider, and market adoption; competitive developments; intellectual property outcomes; financing and operational execution; the ability to identify, negotiate, and consummate acquisitions on expected terms; and, with respect to the proposed merger, the ability to enter into definitive agreements, obtain required approvals, satisfy closing conditions, consummate the transaction on the anticipated timeline or at all, and successfully integrate the businesses. The Company undertakes no obligation to update any forward-looking statements, except as required by law. The Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company’s registration statement and other filings with the U.S. Securities and Exchange Commission.

About YD Bio Limited

YD Bio Limited is a biotechnology company focused on advancing clinical trials, new drug development, cancer prevention diagnostics, and stem cell and exosome therapies with the potential to transform the treatment of diseases with high unmet medical need. The Company is committed to improving patient outcomes through scientific innovation and precision medicine. In addition to its R&D efforts, YD Bio Limited is a recognized supplier of clinical trial drugs and has expanded into the development and distribution of post-market auxiliary products. For more information, please visit the Company’s website: ir.ydesgroup.com

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