Duyuru • Jan 06

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

YD Bio Limited 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. 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 initiatives and their results, and strategic growth across 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. Cell Therapy and Exosome platform: Manufacturing and Regulatory De- risking Completed: Cell Therapy andExosome Platform: Manufacturing and regulatory De-risking Completed: Cell therapy and Exosome Platform: manufacturing and Regulatory De-risking completed: Cell Therapy and Exosomes: Cell Therapy and Exosom Platform: Manufacturing and Regulatory De -risking Completed: Cell Therapy and Exos genome Platform: Manufacturing and Regulatory De the FDA: Cell Therapy and Exosate Platform: Manufacturing and Regulatory De.risking Completed: Cell Therapy & Exosome Platform: Manufacturing & Regulatory De-risking Completed: cell Therapy and Exosome Platform - Manufacturing and Regulatory De-risked Completed: Cell Therapy and Exoome Platform: Manufacturing and Regulatory de-risking Completed: Cell Therapy, Manufacturing, and Controls (CMC) development for its Limbal Stem Cells and LSC-derived exosomes. 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 andLSC-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. 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. Initiation and conclusion of efficacy and toxicity studies; and IND submission to the US FDA; Expected in 2027: Entry into first-in-human clinical trials. 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, 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. Collectively, the anticipated. Collectively, the Company plans to pursue these strategic moves to accelerate internal clinical initiations beginning in 2026, subject to successful completion of preclinical work, the anticipated outcome of these acquisitions.

CEO maaş yüzdesi	n/a
CEO görev süresi	2.3yrs
CEO sahipliği	16.0%
Yönetim ortalama görev süresi	Veri yok
Yönetim Kurulu ortalama görev süresi	less than a year

İsim	Pozisyon	Görev süresi	Tazminat	Sahiplik
Ethan Shen	CEO & Chairman	2.3yrs	Veri yok	15.96% $ 25.0m
Benjamin Zhang	Chief Medical Officer & Director	1.5yrs	Veri yok	Veri yok
Yin Chia Lee	Independent Director	less than a year	Veri yok	Veri yok
Jan Hall	Director	less than a year	Veri yok	Veri yok
Michaela Griggs	Director	less than a year	Veri yok	Veri yok
Shao-Da Lu	Director	less than a year	Veri yok	Veri yok
Kochi Chang	Director	less than a year	Veri yok	0.011% $ 17.5k

Veri	Son Güncelleme (UTC saati)
Şirket Analizi	2026/07/12 06:49
Gün Sonu Hisse Fiyatı	2026/07/10 00:00
Kazançlar	2024/12/31
Yıllık Kazançlar	2024/12/31

Paket	Veri	Zaman Çerçevesi	Örnek ABD Kaynağı ^*
Şirket Finansalları	10 yıl	Gelir tablosu Nakit akış tablosu Bilanço	SEC Form 10-K SEC Form 10-Q
Analist Konsensüs Tahminleri	+3 yıl	Finansal tahminler Analist fiyat hedefleri	Analist Araştırma Raporları Blue Matrix
Piyasa Fiyatları	30 yıl	Hisse senedi fiyatları Temettüler, Bölünmeler ve Eylemler	ICE Piyasa Verileri SEC Form S-1
Sahiplik	10 yıl	En büyük hissedarlar İçeriden öğrenenlerin ticareti	SEC Form 4 SEC Form 13D
Yönetim	10 yıl	Liderlik ekibi Yönetim Kurulu	SEC Form 10-K SEC Form DEF 14A
Önemli Gelişmeler	10 yıl	Şirket duyuruları	SEC Form 8-K

YD Bio Yönetim

Yönetim kriter kontrolleri 0/4

Anahtar bilgiler

Son yönetim güncellemeleri

Less than half of directors are independent

YD Bio Limited Announces Committee Changes, Effective January 16, 2026

YD Bio Limited Announces Directorate Changes

YD Bio Limited Announces the Resignation of May Tsai as Chief Operating Officer, Effective September 24, 2025

Recent updates

YD Bio Extends Laboratory Operations to 46 States With New Cancer Detection Licenses

Less than half of directors are independent

YD Bio Limited Announces Committee Changes, Effective January 16, 2026

YD Bio Limited Announces Directorate Changes

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

YD Bio Limited Expands OkaiDx Testing Portfolio to Pancreatic and Colorectal Cancer Detection Across the U.S

YD Bio Limited Announces U.S. Ophthalmology Market Entry, Advances Across Diagnostics and LSC Exosome Therapeutics

YD Bio Limited announced that it has received $13.2 million in funding

YD Bio Limited Announces the Resignation of May Tsai as Chief Operating Officer, Effective September 24, 2025

YD Biopharma Limited Files Form 15

CEO

Yönetim Kurulu Üyeleri

Şirket Analizi ve Finansal Veri Durumu

Veri Kaynakları

Analiz Modeli ve Kar Tanesi

Endüstri ve Sektör Metrikleri

Analist Kaynakları