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

Rhea-AI Summary

Creative Medical Technology Holdings (NASDAQ: CELZ) announced a second WHO International Nonproprietary Name (INN) milestone: the WHO published the proposed INN etaroleucel for CELZ-101 in Proposed INN List 134 following the 80th INN Consultation.

The name is entering the formal objection period prior to final confirmation. This follows prior proposed INN olastrocel for CELZ-201 in Proposed INN List 133, reinforcing multi-program regulatory positioning.

Positive

• Second proposed WHO INN achieved for etaroleucel (CELZ-101)
• Demonstrates multi-program regulatory progress across distinct cell therapy platforms
• Prior proposed INN olastrocel (CELZ-201) underscores repeatable WHO engagement

Negative

• Proposed INN etaroleucel is entering a formal objection period pending final confirmation

News Market Reaction

+1.58%

1 alert

+1.58% News Effect

On the day this news was published, CELZ gained 1.58%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

80th WHO INN Consultation: March 18–21, 2025 Proposed INN List: List 134 79th WHO INN Consultation: October 22–25, 2024 +1 more

4 metrics

80th WHO INN Consultation March 18–21, 2025 Etaroleucel (CELZ-101) reviewed in this consultation

Proposed INN List List 134 WHO list including etaroleucel for CELZ-101

79th WHO INN Consultation October 22–25, 2024 Olastrocel INN review for CELZ-201

Proposed INN List List 133 WHO list including olastrocel for CELZ-201

Market Reality Check

Price: $1.89 Vol: Volume 14,793 vs 20-day a...

low vol

$1.89 Last Close

Volume Volume 14,793 vs 20-day average 103,646 suggests limited pre-news participation. low

Technical Price 1.90 trades below 200-day MA at 2.71, reflecting a longer downtrend.

Peers on Argus

CELZ slipped 1.55% while peers showed mixed moves: ERNA down 11.58%, RNAZ up 24....

1 Up 1 Down

CELZ slipped 1.55% while peers showed mixed moves: ERNA down 11.58%, RNAZ up 24.65%, others near flat. With no clear directional consensus and scanner names split between up and down, trading looked stock-specific rather than a coordinated biotech move.

Historical Context

5 past events · Latest: Jan 13 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 13	Interim trial data	Positive	-11.2%	Strong ADAPT 180-day efficacy and safety data for CELZ-201 in chronic back pain.
Jan 06	Program approval	Positive	+9.3%	Regulatory approval for BioDefense Burn Pit Initiative to expand veteran data collection.
Dec 17	Trial enrollment done	Positive	+1.2%	Completed enrollment in FDA-cleared ADAPT trial for CELZ-201 in back pain.
Dec 02	WHO INN approval	Positive	-11.8%	WHO approved olastrocel as INN for lead allogeneic cell therapy CELZ-201.
Oct 30	Program launch	Positive	-13.0%	Launched BioDefense Veterans Initiative using iPSC and AI for burn pit exposure.

Pattern Detected

Positive clinical and regulatory news has often seen mixed-to-negative next-day price reactions for CELZ.

Recent Company History

Over the last few months, CELZ has reported multiple positive clinical and regulatory milestones, including completion of ADAPT enrollment on Dec 17, 2025 and strongly positive interim ADAPT data on Jan 13, 2026. WHO INN approval for olastrocel on Dec 2, 2025 and launch/approval steps for the BioDefense burn pit initiative expanded the pipeline. Despite these developments, several announcements were followed by double‑digit percentage declines, underscoring a history of volatile or skeptical market responses to good news.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-11-21

An effective Form S-3 dated Nov 21, 2025 covers 2,790,340 common shares for resale by existing investors upon warrant exercise. The company will not sell shares directly in this offering and would only receive cash upon warrant exercises. The filing notes that ongoing resale activity by holders could pressure the share price over time.

Market Pulse Summary

This announcement highlights CELZ’s second WHO INN achievement, adding etaroleucel for CELZ-101 to p...

Analysis

This announcement highlights CELZ’s second WHO INN achievement, adding etaroleucel for CELZ-101 to prior olastrocel recognition for CELZ-201. These steps support global regulatory positioning across autologous and allogeneic cell therapy programs. Recent filings indicate potential resale activity from warrant-related shares, which could influence trading dynamics. Key metrics to watch include further clinical data, additional regulatory milestones, and updates on commercialization planning for the lead indications.

Key Terms

international nonproprietary name (inn), world health organization (who), autologous regulatory t-cell (treg), type 1 diabetes

4 terms

international nonproprietary name (inn) regulatory

"announced the achievement of its second International Nonproprietary Name (INN) milestone"

An international nonproprietary name (INN) is the globally recognized generic name given to an active drug ingredient by the World Health Organization, serving as the official, unique label for that substance across countries and languages. For investors, an INN matters because it identifies the core medicine regardless of brand, helping track regulatory approvals, generic competition, licensing deals and market size—think of it as the drug’s universal street name that lets you compare products from different makers.

world health organization (who) regulatory

"its second International Nonproprietary Name (INN) milestone with the World Health Organization (WHO)"

The World Health Organization (WHO) is the United Nations agency that coordinates international public health guidance, disease surveillance, and response efforts across countries. Investors watch WHO announcements because its guidance and alerts — similar to a global health traffic controller directing where resources and restrictions should move — can change government policies, travel and trade flows, pharmaceutical demand, and market sentiment, all of which can affect company revenues and stock prices.

autologous regulatory t-cell (treg) medical

"the Company’s autologous regulatory T-cell (Treg) immunotherapy program"

Autologous regulatory T-cells (Tregs) are a patient’s own immune cells that act like a thermostat to dial down excessive immune reactions; they are collected, sometimes expanded in a lab, and given back to help prevent inflammation, autoimmune damage, or organ rejection. Investors care because these personalized cell therapies represent a high-cost, high-complexity medical product with potential for large markets, significant manufacturing and regulatory challenges, and outcomes that can strongly affect clinical and commercial value.

type 1 diabetes medical

"including Type 1 diabetes in the context of pancreatic islet transplantation"

An autoimmune condition in which the pancreas stops producing insulin, a hormone that lets the body use sugar for energy; without insulin people must manage blood sugar with injections, pumps, or other therapies. For investors, it matters because the lifelong need for medicines, devices, and monitoring creates steady demand, influences healthcare spending and reimbursement decisions, and drives clinical trials and regulatory activity in the diabetes treatment market.

AI-generated analysis. Not financial advice.

WHO recognition of “etaroleucel” (CELZ-101) builds on prior “olastrocel” (CELZ-201) milestone, reinforcing platform credibility and supporting multi-program execution

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 Pipeline
With 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, visit www.creativemedicaltechnology.com

Forward-Looking Statements
This 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 Contacts
Creative Medical Technology Holdings, Inc.
IR@CreativeMedicalTechnology.com
www.creativemedicaltechnology.com

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

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

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

FAQ

What did Creative Medical (CELZ) announce about etaroleucel on February 10, 2026?

Creative Medical announced that the WHO published the proposed INN etaroleucel for CELZ-101. According to the company, the name appeared in Proposed INN List 134 after the 80th WHO INN Consultation and now enters a formal objection period.

How does the proposed INN etaroleucel affect CELZ-101 clinical development and global recognition?

Proposed INN publication provides standardized international naming beneficial for global trials and regulatory dialogue. According to the company, INN recognition supports clinical development, regulatory alignment, and future commercialization planning across jurisdictions.

Has Creative Medical previously achieved WHO INN recognition for other programs (CELZ)?

Yes, Creative Medical previously had olastrocel published as a proposed INN for CELZ-201. According to the company, olastrocel appeared in Proposed INN List 133 after the 79th WHO INN Consultation in October 2024.

What is CELZ-101 (etaroleucel) being developed to treat and where has the platform shown validation?

CELZ-101 is an autologous regulatory T-cell immunotherapy aimed at inducing immune tolerance in complex autoimmune settings. According to the company, the platform is being developed for Type 1 diabetes with islet transplantation and validated in cardiovascular and hepatic applications.

What is the current regulatory status of etaroleucel following the WHO publication?

The proposed INN etaroleucel has been published but is not yet final. According to the company, the name is entering the WHO's formal objection period prior to final confirmation.