Creative Medical Technology Holdings Announces World Health Organization Approval of “olastrocel” as INN for Lead Allogeneic Cell Therapy CELZ-201

Rhea-AI Summary

Creative Medical (NASDAQ: CELZ) announced on Dec 2, 2025 that the World Health Organization approved olastrocel as the International Non‑Proprietary Name (INN) for the active cellular substance in its lead allogeneic cell therapy CELZ‑201 (AlloStem).

The INN gives a globally standardized scientific name to the asset, aiding regulatory and clinical clarity, pharmacovigilance, labeling, and international development. Company leadership said the milestone supports global advancement and complements the program’s FDA Fast Track designation in degenerative disc disease. Olastrocel is being developed as an off‑the‑shelf perinatal‑tissue cell therapy for chronic lower back pain/DDD, new‑onset type 1 diabetes, and biodefense‑related indications.

News Market Reaction

-11.75% 1.8x vol

14 alerts

-11.75% News Effect

+8.3% Peak Tracked

-21.7% Trough Tracked

-$862K Valuation Impact

$6M Market Cap

1.8x Rel. Volume

On the day this news was published, CELZ declined 11.75%, reflecting a significant negative market reaction. Argus tracked a peak move of +8.3% during that session. Argus tracked a trough of -21.7% from its starting point during tracking. Our momentum scanner triggered 14 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $862K from the company's valuation, bringing the market cap to $6M at that time. Trading volume was above average at 1.8x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Market Reality Check

Price: $1.97 Vol: Volume 55,686 is 0.51x th...

low vol

$1.97 Last Close

Volume Volume 55,686 is 0.51x the 20-day average of 109,542, indicating muted pre-news activity. low

Technical Shares at $2.21 are trading below the $2.90 200-day moving average, reflecting a weak longer-term trend.

Peers on Argus

CELZ was flat at 0% ahead of the INN news, while peers showed mixed moves (e.g.,...

CELZ was flat at 0% ahead of the INN news, while peers showed mixed moves (e.g., ERNA up 18.4%, RNAZ up 6.33%, others modestly negative), suggesting stock-specific dynamics rather than a unified biotech move.

Historical Context

5 past events · Latest: Dec 02 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 02	INN designation	Positive	-11.8%	WHO approval of INN olastrocel for CELZ-201 lead cell therapy.
Oct 30	Strategic initiative	Positive	-13.0%	Launch of regenerative BioDefense initiative for veterans exposed to burn pits.
Oct 29	Warrant financing	Negative	-32.7%	Inducement warrant exercises raising proceeds and issuing new warrants.
Oct 27	Shareholder update	Positive	+5.4%	Letter outlining clinical milestones, Fast Track status, and IP progress.
Oct 07	Patent/IP news	Positive	+0.9%	Announcement of two U.S. patents for ImmCelz T-regulatory cell platform.

Pattern Detected

Recent history shows mixed reactions: financing-related dilution aligned with a sharp selloff, while several positive R&D and IP updates saw modest gains, but two seemingly positive strategic/clinical news items were followed by notable declines.

Recent Company History

Over the last six months, Creative Medical issued multiple updates spanning clinical progress, IP, and financing. A shareholder letter on Oct 27, 2025 highlighted FDA Fast Track for CELZ‑201 and upcoming 2026 data, and patents for diabetes and heart failure, with a 5.43% gain. However, an Oct 29, 2025 warrant exercise and inducement deal tied to $3.75 exercise prices led to a -32.74% move. Subsequent BioDefense and INN announcements on Oct 30 and Dec 2, 2025 were followed by -13.03% and -11.75% respectively, indicating the market has sometimes sold into positive narratives.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-11-21

An effective Form S-3 filed on Nov 21, 2025 registers 2,790,340 shares for resale by existing investors tied to inducement warrants from the October 29, 2025 transaction. The company will not sell shares or receive proceeds from these resales, but could receive cash upon warrant exercise. The prospectus notes that resale of large blocks over time could pressure the stock, and full exercise would raise outstanding shares to 6,045,440 from 3,255,100.

Market Pulse Summary

The stock dropped -11.8% in the session following this news. A negative reaction despite the WHO INN...

Analysis

The stock dropped -11.8% in the session following this news. A negative reaction despite the WHO INN designation would fit prior instances where seemingly positive strategic or clinical updates were followed by declines, as seen after the BioDefense initiative and the INN news on Dec 2, 2025. Overhang from inducement warrants and registered resale shares on the S‑3 could amplify selling pressure, and past financing-related moves have coincided with notable drawdowns.

Key Terms

international non-proprietary name, inn, allogeneic, pharmacovigilance, +2 more

6 terms

international non-proprietary name regulatory

"approved “olastrocel” as the International Non-Proprietary Name (INN) for the active"

An international non-proprietary name (INN) is the official, globally recognized generic name given to an active pharmaceutical substance so everyone — regulators, doctors, and pharmacists — can identify it regardless of brand. Think of it as the drug’s common name, like ‘aspirin’ versus a brand label; for investors it matters because the INN clarifies what a product actually contains, affects approval and labeling, and helps assess competition from generics and potential market size.

inn regulatory

"The INN is the globally standardized, unique scientific name used by regulators,"

An INN (International Nonproprietary Name) is the official generic name assigned to a pharmaceutical substance so it can be recognized worldwide, like a common name for a chemical compound rather than a brand label. Investors use INNs to spot when different companies are selling the same drug under different brands, assess competition and generic substitution risks, and evaluate whether a product is likely to face patent-free market pressure once proprietary protection ends.

allogeneic medical

"lead allogeneic cell therapy also known as AlloStem®."

Allogeneic describes a process or material involving different individuals of the same species, such as cells, tissues, or organs donated from one person to another. It is important to investors because products or treatments based on allogeneic sources can enable scalable, off-the-shelf solutions, potentially reducing costs and increasing accessibility in healthcare and biotech industries.

pharmacovigilance medical

"labeling, and pharmacovigilanceA competitive advantage as this therapy progresses"

Pharmacovigilance is the process of monitoring and assessing the safety of medicines after they are on the market, ensuring that any side effects or risks are identified and managed. For investors, it matters because it helps ensure that pharmaceutical companies maintain safe products, which can influence a company’s reputation, regulatory approval, and financial stability over time.

biodefense medical

"Type 1 diabetes (new-onset)Biodefense-related indications"

Biodefense is the set of tools, technologies and services designed to detect, prevent or respond to biological threats such as infectious diseases, engineered pathogens or accidental releases. For investors it signals a market focused on diagnostics, vaccines, protective gear, and rapid response systems — similar to an alarm-and-firefighting network for biological risks — which can drive revenue growth, government contracts and regulatory scrutiny depending on outbreak risks and public policy priorities.

perinatal tissue medical

"cellular therapeutic candidate derived from perinatal tissue and developed under"

Perinatal tissue is the biological material that surrounds and supports a baby during birth—such as the placenta, umbilical cord, and amniotic membrane—collected after delivery and used in medical treatments. Investors should care because these tissues are a source of regenerative therapies and wound-care products, so their clinical effectiveness, regulatory approval, ethical sourcing and supply availability directly affect a company’s product pipeline, market potential and legal risk, much like a key raw material for a growing industry.

AI-generated analysis. Not financial advice.

Global assignment of this unique name enhances international clarity, strengthens regulatory positioning, and supports olastrocel’s advancement across large unmet-need global markets

PHOENIX, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) (“Creative Medical” or the “Company”), a clinical-stage biotechnology company developing next-generation regenerative and immune cell therapies, today announced that the World Health Organization (WHO) has approved “olastrocel” as the International Non-Proprietary Name (INN) for the active cellular substance in CELZ-201, the Company’s lead allogeneic cell therapy also known as AlloStem®.

The INN is the globally standardized, unique scientific name used by regulators, clinicians, researchers, and global markets to identify a therapeutic substance throughout its development and commercialization lifecycle. This assignment is a key global milestone that typically occurs as a program advances into later regulatory stages and requires unified international identification.

“Securing the name ‘olastrocel’ marks an important advancement for our program,” said Timothy Warbington, President and CEO of Creative Medical. “A WHO-recognized INN is foundational for global development, medical adoption, and long-term scalability. It provides a cohesive scientific identity for the asset as we continue to execute on our clinical strategy in large markets with significant unmet medical needs.”

Mr. Warbington continued, “From an investor perspective, this milestone reflects disciplined progress and strengthens the foundation for the olastrocel platform. Combined with our FDA Fast Track designation in degenerative disc disease, we believe the program is well-positioned as we move toward additional clinical catalysts ahead. The therapeutic areas we are targeting - chronic lower back pain, diabetes, and immune-mediated conditions - represent multi-billion-dollar opportunities where innovation is urgently needed.

“Our team remains focused, data-driven, and committed to advancing olastrocel through the next phases of development,” he added. “This is an exciting moment for Creative Medical and our shareholders as we continue building a differentiated, next-generation cell therapy franchise.”

Why the INN Matters
The assignment of “olastrocel” provides:

• Globally harmonized scientific identification of the active substance
• Regulatory and clinical clarity across jurisdictions during development
• Improved efficiency in global submissions, labeling, and pharmacovigilance
• A competitive advantage as this therapy progresses toward later-stage development
• Strengthened positioning in sizable therapeutic markets
  

About Olastrocel (CELZ-201)

olastrocel is an allogeneic, off-the-shelf cellular therapeutic candidate derived from perinatal tissue and developed under the Company’s AlloStem® platform. It is in clinical development for:

• Chronic lower back pain & degenerative disc disease (DDD)
• Type 1 diabetes (new-onset)
• Biodefense-related indications
  

About Creative Medical Technology Holdings, Inc.

Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company advancing a pipeline of cell and immune therapies targeting unmet needs in neurology, urology, orthopedics, and autoimmune diseases. The Company leverages proprietary regenerative medicine platforms, extensive scientific expertise, and a robust regulatory strategy to accelerate therapeutic innovation. For more information, please visit www.creativemedicaltechnology.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding regulatory pathways, clinical development milestones, potential therapeutic applications, and the Company’s strategic outlook. These statements are based on current expectations and are subject to various risks and uncertainties that could cause actual outcomes to differ materially. These risks include, but are not limited to, clinical trial results, regulatory decisions, manufacturing challenges, market conditions, and other factors described in the Company’s filings with the SEC. Creative Medical Technology assumes no obligation to update such statements except as required by law.

Contact

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 on December 2, 2025 about olastrocel?

The company announced WHO approval of olastrocel as the International Non‑Proprietary Name for CELZ‑201.

How does the WHO INN approval of olastrocel affect CELZ‑201 regulatory processes?

The INN provides globally harmonized identification, aiding submissions, labeling, and pharmacovigilance across jurisdictions.

Which indications is olastrocel (CELZ‑201) being developed for?

Olastrocel is in clinical development for chronic lower back pain/degenerative disc disease, new‑onset type 1 diabetes, and biodefense‑related indications.

Does Creative Medical have any FDA designation for olastrocel (CELZ‑201)?

Yes; the company cites an existing FDA Fast Track designation in degenerative disc disease.

Why is an INN like olastrocel important for investors in CELZ?

An INN can improve regulatory and commercial clarity internationally and is a milestone that typically aligns with later clinical development stages.

What is the origin and format of olastrocel (CELZ‑201)?

Olastrocel is described as an allogeneic, off‑the‑shelf cellular therapeutic derived from perinatal tissue under the AlloStem platform.