YD Bio Limited Expands U.S. Presence with Newly Planned California Facilities and Operations Center

Rhea-AI Summary

YD Bio (Nasdaq: YDES) announced plans to establish a California operations center and new U.S. facilities to accelerate clinical development, regulatory engagement and commercial access for DNA methylation cancer diagnostics, exosome therapeutics and ophthalmologic programs.

The site is in site evaluation with city not finalized; the company will recruit U.S. regulatory, clinical and operations staff and activate the site in phases. YD Bio said the center will support FDA interactions, clinical trial coordination, market access, and align with a partner’s recent NT$210 million ($6.72M) U.S. GMP plant investment.

Positive

• Alignment with partner NT$210 million ($6.72M) U.S. GMP plant
• California center intended to speed FDA engagement and pre‑submission interactions
• Planned hub to support clinical validation and U.S. market access initiatives

Negative

• Site still in evaluation; host city not finalized, risking timeline delays
• Phased staffing and commissioning will increase near‑term operating costs

News Market Reaction

+1.04%

3 alerts

+1.04% News Effect

+$10M Valuation Impact

$945M Market Cap

0.3x Rel. Volume

On the day this news was published, YDES gained 1.04%, reflecting a mild positive market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $10M to the company's valuation, bringing the market cap to $945M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Public warrant shares: 11,500,000 shares Resale registration: 59,136,934 shares Private warrant shares: 5,425,000 shares +5 more

8 metrics

Public warrant shares 11,500,000 shares Ordinary shares issuable upon exercise of Public Warrants

Resale registration 59,136,934 shares Existing ordinary shares registered for resale

Private warrant shares 5,425,000 shares Ordinary shares issuable upon exercise of Private Warrants

Warrant exercise price $11.50 Exercise price per share for Public Warrants

Public warrant proceeds $132,250,000 Potential cash to company if Public Warrants fully exercised

Private warrant proceeds $62,387,500 Potential cash to company if Private Warrants fully exercised

Shares outstanding 70,521,359 shares Ordinary shares outstanding as of Oct 22, 2025

Fully diluted shares 87,437,359 shares Shares if all registered warrants exercised

Market Reality Check

Price: $11.05 Vol: Price up 0.73% with volum...

low vol

$11.05 Last Close

Volume Price up 0.73% with volume 37,220 vs 20-day average 102,730 (relative volume 0.36). low

Technical Shares at 12.49, trading below 200-day MA of 14.82 and about midway in the 52-week 7.20–25.00 range.

Peers on Argus

YDES gained 0.73% while key biotech peers were mostly lower (e.g., ABCL -3.04%, ...

YDES gained 0.73% while key biotech peers were mostly lower (e.g., ABCL -3.04%, BHVN -2.93%, JANX -2.64%, PHVS -1.40%), with only SNDX up 2.00%. This points to a stock‑specific reaction to the U.S. expansion news rather than a broad sector move.

Historical Context

5 past events · Latest: Dec 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 09	Trade show showcase	Positive	-18.4%	Showcased OkaiDx and exosome programs at Healthcare Expo Taiwan with strong booth traffic.
Dec 02	Clinical data update	Positive	+3.7%	Expanded OkaiDx to pancreatic and colorectal detection and shared high-sensitivity PDAC data.
Nov 24	Ophthalmology entry	Positive	+4.5%	Announced U.S. ophthalmology entry with 510(k) clearance and LSC exosome therapeutic advances.
Nov 05	RUO test launch	Positive	-3.1%	Expanded access to OkaiDx cfDNA-methylation test for post-treatment breast cancer monitoring.
Oct 20	Nasdaq listing	Positive	-0.9%	Rang Nasdaq opening bell, emphasizing licenses, CLIA/CAP lab and commercialization plans.

Pattern Detected

Recent company news has produced mixed reactions: some commercial and clinical milestones saw gains, while other seemingly positive updates were followed by notable selloffs.

Recent Company History

Over the last few months, YD Bio has highlighted multiple U.S.-focused growth steps. On Oct 20, 2025, it celebrated its Nasdaq listing and outlined plans around its CLIA/CAP lab and long‑term commercialization. Subsequent releases expanded OkaiDx™ access and reported strong breast and pancreatic cancer test performance, plus new U.S. ophthalmology milestones. A recent Taiwan expo appearance drew significant interest but was followed by a large share-price drop. Today’s California operations plan continues this theme of expanding U.S. clinical and commercial infrastructure.

Market Pulse Summary

This announcement details YD Bio’s plan for a California operations center to support clinical, regu...

Analysis

This announcement details YD Bio’s plan for a California operations center to support clinical, regulatory and commercial efforts, aligned with a partner’s NT$210 million ($6.72 million) GMP cell therapy investment. It builds on recent U.S. expansion across OkaiDx™ cancer testing and ophthalmology. Investors may track progress on site selection, phased activation, FDA-facing activities, and any utilization of the registered 11,500,000 Public and 5,425,000 Private Warrants as key indicators of execution and capital structure evolution.

Key Terms

DNA methylation-based, exosome-based therapeutics, GMP, cell therapy, +4 more

8 terms

DNA methylation-based medical

"a biotechnology company advancing DNA methylation-based cancer detection technology"

A dna methylation-based approach uses chemical tags on DNA—like sticky notes on an instruction manual—to read or influence which genes are turned on or off. In finance and medicine this describes tests, biomarkers, or therapies that rely on those tags to detect disease, predict outcomes, or guide treatment. Investors care because such technology can create diagnostic products, licensed data or drug targets, and therefore revenue potential, regulatory hurdles, and commercialization risk.

exosome-based therapeutics medical

"next‑generation diagnostics and exosome‑based therapeutics"

Therapies that use exosomes — tiny, natural packets cells send to communicate — to deliver therapeutic molecules or signals to other cells. Think of them as a biological mailing service that can carry instructions or repair tools to specific tissues; for investors they represent a potential new class of targeted medicines with advantages in precision and safety, but they also carry development, manufacturing and regulatory risks common to early-stage biotech.

GMP technical

"build a GMP (Good Manufacturing Practice) cell therapy manufacturing plant in the U.S."

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

cell therapy medical

"build a GMP (Good Manufacturing Practice) cell therapy manufacturing plant in the U.S."

Cell therapy uses living human or animal cells as the medicine: cells are collected, sometimes grown or altered, and then given to a patient to repair, replace, or boost damaged tissue or immune function. For investors, cell therapies can transform markets because they may offer one-time or highly effective treatments that command premium prices, but they also carry high development, manufacturing and regulatory costs and commercial risks, like building a custom factory rather than making a simple product.

IRB medical

"Support for clinical trial design, IRB coordination, and integration with U.S. health systems"

An Institutional Review Board (IRB) is an independent committee that reviews and approves medical and behavioral research involving people to ensure safety, informed consent, and ethical treatment—think of it as a safety inspector for studies. For investors, IRB decisions matter because their approval or requests for changes can speed up, delay, or halt clinical trials and other studies, directly affecting timelines, costs, and the value of companies developing treatments.

CDMOs technical

"Integration with U.S. CDMOs and establishment of scalable quality, production"

Contract Development and Manufacturing Organizations (CDMOs) are independent companies that help drug and biologic developers by designing, testing, scaling up and producing medicines on a contract basis — think of them as a hired factory and research partner that turns a medical idea into a manufacturable product. They matter to investors because they provide steady, service-based revenue, spread development and production risk for drug makers, and their capacity, quality and pricing can directly affect the speed and cost of getting medicines to market.

pre‑IND/IDE regulatory

"Primary interface for FDA engagement, including pre‑IND/IDE interactions"

Pre‑IND/IDE describes early interactions between a company and regulators before the formal filings required to test a new drug or medical device in humans. Think of it as a blueprint review with a building inspector: companies present plans and data to get feedback on safety tests, trial design, and required information so regulators won’t be surprised later. For investors, positive pre‑IND/IDE feedback can lower regulatory risk, clarify timelines and costs, and improve the odds a program advances to clinical testing.

Good Manufacturing Practice regulatory

"a NT$210 million ($6.72 million) investment to build a GMP (Good Manufacturing Practice)"

Good manufacturing practice (GMP) are the rules and routines companies must follow to make products consistently safe and effective, covering everything from equipment and cleanliness to staff training and recordkeeping. For investors, GMP compliance signals lower risk of product failures, regulatory fines, production stoppages or costly recalls—like a reliable recipe and tidy kitchen that help ensure every batch turns out the same and customers stay satisfied.

AI-generated analysis. Not financial advice.

Taipei, Taiwan, Dec. 16, 2025 (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 initiation of its latest plans for new facilities and a U.S. operations center in California to accelerate clinical development, regulatory engagement and commercial access for next‑generation diagnostics and exosome‑based therapeutics.

The California operations center is currently in the site evaluation phase and the specific host city has not yet been finalized. It will support clinical collaboration, regulatory strategy and scaled operational capabilities, which is intended to assist with enabling faster clinical validation, more efficient regulatory submissions and improved access to non‑invasive cancer tests and advanced diagnostic services across the United States.

The expansion reflects YD Bio’s commitment to translating innovative science into patient benefit while creating high‑quality local employment, Dr. Ethan Shen, Chairman and CEO of the Company, commented. “The Company will recruit scientific, regulatory and operational talent and will activate the site in phases, beginning with site selection and staffing, followed by staged commissioning of laboratory, manufacturing support and commercial functions to ensure a compliant and efficient ramp to full operations.”

The Company will operate the California center through four strategic pillars:

1) Clinical & Regulatory Frontline

• Primary interface for FDA engagement, including pre‑IND/IDE interactions
  
  
• Support for clinical trial design, IRB coordination, and integration with U.S. health systems
  
  
• Reduction of time‑zone and regulatory friction to accelerate evidence generation
  
  

2) Market Access & Commercial Readiness

• Development of partnerships with U.S. providers, key opinion leaders (KOLs), and industry stakeholders
  
  
• Market education and early positioning for diagnostics, exosome programs, and cell therapies
  
  
• Enablement of B2B licensing, collaborations, and strategic investment initiatives
  
  

3) Manufacturing & Supply Chain Interface

• Alignment with 3D Global Biotech’s U.S. GMP manufacturing investments
  
  
• Central operations hub for prospective owned or acquired GMP facilities
  
  
• Integration with U.S. CDMOs and establishment of scalable quality, production, and logistics pathways
  
  

4) Talent & Operations Hub

• Recruitment of U.S.-based regulatory, clinical, operations, and commercial talent
  
  
• Support for YD Bio’s global R&D and commercialization activities
  
  
• Phased activation to prudently manage cost and risk
  
  

3D Global Biotech’s New GMP Plant

YD Bio views the California center as a strategic enabler supporting efforts to shorten development timelines and expand patient access to less invasive diagnostic tools and therapeutic programs. It is expected to facilitate accelerated clinical validation, streamline pre‑submission interactions and enhance readiness for future commercialization activities.

The plan is also consistent with YD Bio’s broader regional momentum in cross‑border biomanufacturing and cell therapy investment. The Company’s partner 3D Global Biotech Inc. recently announced a NT$210 million ($6.72 million) investment to build a GMP (Good Manufacturing Practice) cell therapy manufacturing plant in the U.S., underscoring growing industry interest in establishing local manufacturing and regulatory footholds to support clinical and commercial ambitions. YD Bio intends to align its California operations center with this GMP build‑out to strengthen end‑to‑end coordination across development, quality and supply chain functions.

About YD Bio Limited

YD Bio Limited is a biotechnology company focused on advancing clinical trials, new drug development, cancer prevention diagnostics, and limbal 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

Forward-Looking Statements

Certain statements in this announcement are forward-looking statements, including, but not limited to, YD Bio’s business plan and outlook. These forward-looking statements involve known and unknown risks and uncertainties and are based on YD Bio’s current expectations and projections about future events that YD Bio believes may affect its financial condition, results of operations, business strategy and financial needs. 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. YD Bio undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although YD Bio believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and YD Bio 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 YD Bio’s registration statement and other filings with the U.S. Securities and Exchange Commission.

For investor and media inquiries, please contact:

YD Bio Limited
Investor Relations
Email: investor@ydesgroup.com

WFS Investor Relations Inc.
Email: services@wealthfsllc.com
Phone: +1 628 283 9214

FAQ

What will YD Bio (YDES) use the new California operations center for?

To support FDA engagement, clinical trial design and coordination, U.S. market access and scaled operations for diagnostics and exosome therapeutics.

Has YD Bio finalized the location and opening date for the California site (YDES)?

No; the center is in the site evaluation phase and the specific host city has not been finalized.

How does YD Bio (YDES) plan to align with 3D Global Biotech’s U.S. GMP plant?

YD Bio intends to align the California operations center with the partner’s NT$210 million ($6.72M) GMP build‑out to support manufacturing and supply chain coordination.

Will YD Bio (YDES) hire U.S.-based staff for the new facilities?

Yes; the company plans to recruit scientific, regulatory, operations and commercial talent and activate the site in phases.

What short-term risks should investors watch regarding YD Bio’s (YDES) U.S. expansion?

Potential timeline delays while selecting a site and increased near‑term operating and commissioning costs from phased activation.