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Creative Medical Technology Holdings Achieves Second WHO INN Milestone, Strengthening Global Regulatory Positioning Across Expanding Cell Therapy Pipeline

Key Takeaway: Creative Medical Technology Holdings has achieved its second International Nonproprietary Name (INN) milestone with the WHO for its autologous T-cell immunotherapy, CELZ-101, now proposed as 'etaroleucel'. This follows the earlier INN recognition of 'olastrocel' for CELZ-201, indicating strong regulatory progress in its expanding cell therapy pipeline aimed at high unmet medical needs.
Price reaction · baseline $1.9 (2026-02-09 close) · hit pre-market · clean, no other CELZ news in the window
day 0 close
+1.6%

Market Sentiment Analysis

POSITIVE FACTORS

  • Achievement of second INN milestone enhances regulatory positioning.
  • Recognition of multiple distinct cell therapy programs by WHO.
  • Potential for scalable, disease-modifying solutions in regenerative medicine.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+79%
120-day peak, hindsight
Typical move
34.3%
average across 2 past catalysts
Cash runway
~17 mo
Low dilution risk
Lead asset
CELZ-201 Administration
Phase 1 · Type 1 Diabetes

Full Press Release Details

PHOENIX, Feb. 10, 2026 (GLOBE NEWSWIRE) --Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) (“Creative Medical” or the “Company”), a regenerative medicine company advancing disruptive cell-based therapies for high-unmet-need indications, today announced the achievement of its second International Nonproprietary Name (INN) milestone with the World Health Organization (WHO), marking continued regulatory progress across its expanding clinical pipeline. INNs are assigned by the WHO to uniquely and universally identify pharmaceutical substances and biologics worldwide.
The WHO has published the proposed INN “etaroleucel” for CELZ-101, the Company’s autologous regulatory T-cell (Treg) immunotherapy program, in Proposed INN List 134, following expert review during the 80th WHO INN Consultation (March 18–21, 2025). As part of the standard WHO process, the name is now entering the formal objection period prior to final confirmation.
CELZ-101 (etaroleucel) is designed to induce immune tolerance in complex autoimmune settings, including Type 1 diabetes in the context of pancreatic islet transplantation. The CELZ-101 platform has also been validated in cardiovascular and hepatic clinical applications.
This achievement follows WHO approval of “olastrocel” as the INN for the active cellular substance in CELZ-201, the Company’s lead allogeneic cell therapy also known as AlloStem®. This name was reviewed during the 79th WHO INN Consultation (October 22–25, 2024) and published in Proposed INN List 133, underscoring Creative Medical’s ability to advance multiple, distinct cell therapy programs through internationally recognized regulatory frameworks.
CELZ-201 (olastrocel) is being developed for chronic lower back pain and degenerative disc disease.
CEO Commentary“Achieving proposed INN status for a second independent clinical program is a powerful validation of both our science and our regulatory execution,” said Timothy Warbington, President and CEO of Creative Medical. “Very few emerging regenerative medicine companies successfully advance multiple platforms through the WHO INN process. The recognition of both olastrocel and etaroleucel highlights the differentiation of our technologies and reflects the growing maturity of our pipeline.”
Warbington continued: “These milestones are not symbolic — they are foundational. INN recognition is essential for global clinical development, regulatory alignment, and eventual commercialization. We believe Creative Medical is building a scalable, internationally credible platform positioned for long-term value creation.”
Momentum Across the PipelineWith both programs advancing through internationally recognized regulatory pathways, Creative Medical continues to execute on its strategy to translate innovative cell technologies.
About Creative Medical Technology Holdings, Inc.Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is a clinical-stage biotechnology company pioneering regenerative medicine therapies derived from adult and perinatal stem cell technologies. The Company’s pipeline targets large, underserved markets across orthopedics, immunotherapy, endocrinology, urology, and gynecology, with a mission to deliver scalable, disease-modifying solutions for patients with high unmet medical needs.
For more information, visitwww.creativemedicaltechnology.com
Forward-Looking StatementsThis press release contains forward-looking statements regarding clinical development, regulatory strategy and positioning, commercialization potential, and market opportunity. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. Factors include clinical trial outcomes, regulatory decisions, manufacturing considerations, competitive dynamics, and market conditions. Please refer to the Company’s filings with the SEC for a discussion of these risks. The Company undertakes no obligation to update forward-looking statements except as required by law.

Investor & Media ContactsCreative Medical Technology Holdings, Inc.IR@CreativeMedicalTechnology.comwww.creativemedicaltechnology.com

Investor RelationsDevin Sullivan — The Equity Group Inc.dsullivan@theequitygroup.com

Conor Rodriguez — The Equity Group Inc.crodriguez@theequitygroup.com

RedChip CompaniesDave Gentry —CELZ@redchip.com| 1-407-644-4256Paul Kuntz —paul@redchip.com| 412-708-4590

Frequently Asked Questions

What is the significance of the WHO INN milestone?

The WHO INN milestone validates the regulatory progress of Creative Medical's therapies.

What is CELZ-101 designed to treat?

CELZ-101 aims to induce immune tolerance in autoimmune conditions like Type 1 diabetes.

What does INN stand for?

INN stands for International Nonproprietary Name, used to identify pharmaceutical substances.

What is the focus of Creative Medical's pipeline?

The pipeline targets large markets in orthopedics, immunotherapy, and endocrinology.

Last updated: Feb 10, 2026