Creative Medical Technology Holdings Reaches Major Clinical Inflection Point with Positive Interim Data from ADAPT Trial and CELZ-201 (Olastrocel) in the Treatment of Chronic Lower Back Pain

Rhea-AI Summary

Creative Medical Technology Holdings (NASDAQ: CELZ) reported positive interim 180-day ADAPT trial data for CELZ-201 (Olastrocel) in chronic lower back pain associated with degenerative disc disease on January 13, 2026. The interim analysis showed mean ODI% improvement −15.3 points (p=0.0003) and mean pain reduction −3.9 points (p<0.00005); ~79% of patients achieved clinically meaningful functional and pain improvements. An independent DSMB found no serious adverse events and no treatment-related safety signals. The company says it will pursue late-stage regulatory engagement, strategic partnerships, and commercialization planning pending final data.

Positive

• ODI functional improvement of −15.3 percentage points at 180 days
• Pain reduced by −3.9 points (0–10 scale) at 180 days
• ~79% of patients reached clinically meaningful improvement
• Independent DSMB confirmed no serious adverse events

Negative

• Data are interim at 180 days; final trial readout not yet reported
• Trial remains blinded with a 4:1 treatment:placebo ratio
• Regulatory engagement and commercialization are pending final data

News Market Reaction – CELZ

-11.22% 3.3x vol

9 alerts

-11.22% News Effect

-30.9% Trough in 24 hr 48 min

-$905K Valuation Impact

$7M Market Cap

3.3x Rel. Volume

On the day this news was published, CELZ declined 11.22%, reflecting a significant negative market reaction. Argus tracked a trough of -30.9% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $905K from the company's valuation, bringing the market cap to $7M at that time. Trading volume was very high at 3.3x the daily average, suggesting heavy selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

ODI% improvement: −15.3 percentage points ODI p-value: p = 0.0003 Functional responders: 79% of patients +5 more

8 metrics

ODI% improvement −15.3 percentage points Mean functional disability improvement at 180 days in ADAPT trial

ODI p-value p = 0.0003 Significance level for functional disability improvement

Functional responders 79% of patients Achieved clinically meaningful ODI% functional improvement

Pain reduction −3.9 points (0–10 scale) Mean pain score reduction at 180 days

Pain p-value p < 0.00005 Significance level for pain reduction endpoint

Pain responders 79% of patients Achieved ≥2‑point reduction in pain score

Randomization ratio 4:1 treatment : placebo Blinded allocation in ADAPT trial per DSMB note

US CLBP prevalence More than 16 million Americans Chronic lower back pain market size reference

Market Reality Check

Price: $1.94 Vol: Volume 132,880 is 10% abo...

normal vol

$1.94 Last Close

Volume Volume 132,880 is 10% above 20-day average 120,548, showing only modestly elevated trading into the news. normal

Technical Shares at $2.05 are trading below the 200-day MA of $2.71 and sit about 70% under the 52-week high.

Peers on Argus

CELZ fell 8.89% while peers were mixed: ERNA +1.56%, RNAZ +2.19%, but APRE, INAB...

1 Up 2 Down

CELZ fell 8.89% while peers were mixed: ERNA +1.56%, RNAZ +2.19%, but APRE, INAB, NLSP declined between roughly 1–7%. Momentum scanner peers (AEON, CLDI, LYRA) also showed both up and down moves, indicating stock-specific pressure rather than a clean sector-wide move.

Historical Context

5 past events · Latest: Jan 06 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 06	Regulatory approval	Positive	+9.3%	National approval for BioDefense Burn Pit data-collection initiative.
Dec 17	Trial enrollment complete	Positive	+1.2%	Completed ADAPT trial enrollment and confirmed favorable DSMB safety.
Dec 02	INN naming	Positive	-11.8%	WHO approved ‘olastrocel’ INN and highlighted Fast Track designation.
Oct 30	Program launch	Positive	-13.0%	Launched regenerative BioDefense initiative for veterans’ burn pit exposure.
Oct 29	Warrant financing	Negative	-32.7%	Inducement warrant exercise for $4.2M gross proceeds and new warrants.

Pattern Detected

Financing-related news drew sharp negative reactions, while regulatory and clinical milestones sometimes sold off despite positive content.

Recent Company History

Over the past few months, CELZ combined financing, regulatory, and clinical milestones. An October 2025 warrant exercise/inducement deal with new warrants led to a -32.74% move, while subsequent BioDefense and WHO INN announcements in late 2025 produced double‑digit declines despite strategic positives. By contrast, completion of ADAPT enrollment on Dec 17, 2025 and Burn Pit regulatory approval on Jan 6, 2026 saw modest and strong gains of 1.2% and 9.31%. Today’s positive interim ADAPT data fits the clinical progression narrative but comes alongside renewed downside pressure.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-11-21

An active Form S-3 from Nov 21, 2025 registers 2,790,340 shares for resale by existing investors upon exercise of inducement warrants. The company itself is not selling shares in this offering and receives no proceeds from resales, though it would receive cash if warrants are exercised. The prospectus notes that sizable secondary sales over time could pressure the share price.

Market Pulse Summary

The stock dropped -11.2% in the session following this news. A negative reaction despite positive in...

Analysis

The stock dropped -11.2% in the session following this news. A negative reaction despite positive interim ADAPT data fits CELZ’s pattern of occasional selloffs on constructive announcements, as seen after prior WHO INN and BioDefense updates. The stock traded about 70% below its 52-week high before this release, with an active S‑3 resale registration for 2,790,340 shares that may weigh on sentiment. Historical warrant-related dilution and secondary-sale risk could amplify downside pressure.

Key Terms

data safety monitoring board, dsmb, placebo, allogeneic, +3 more

7 terms

data safety monitoring board medical

"positive independent Data Safety Monitoring Board (DSMB) safety review, which confirmed"

A data safety monitoring board is a group of experts who regularly review information from a research or testing process to ensure it is safe and ethical. Think of them as watchdogs that watch over ongoing projects to protect participants and ensure everything is proceeding correctly. Their oversight helps maintain trust and safety, which is important for investors who want to see responsible management and reliable results.

dsmb medical

"positive independent Data Safety Monitoring Board (DSMB) safety review, which confirmed"

A DSMB (Data and Safety Monitoring Board) is an independent group of medical and statistical experts that watches over clinical trials to protect participants and ensure the study’s data are reliable. Think of it as an impartial referee who can pause, change, or stop a trial if safety problems, clear benefits, or data flaws appear; its decisions can quickly alter a biotech company’s regulatory path, market value, and investor outlook.

placebo medical

"remaining blinded 4:1 treatment: placebo."

A placebo is an inactive pill, injection or procedure that looks and feels like the real treatment but contains no therapeutic ingredient, often called a sugar pill. Investors care because comparing a drug to a placebo reveals whether observed benefits come from the medicine itself or from expectation; clear superiority over placebo reduces regulatory and commercial risk, much like a blind taste test proves a new recipe really tastes better.

allogeneic medical

"CELZ-201 (Olastrocel) is an off-the-shelf, allogeneic regenerative cell therapy"

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.

degenerative disc disease medical

"for chronic lower back pain associated with degenerative disc disease."

Degenerative disc disease is the gradual breakdown of the soft, cushion-like discs between spinal bones, which can cause chronic back or neck pain and reduced mobility. Like the worn-out shock absorbers on a car, failing discs lead to compensating repairs and replacements, creating sustained demand for treatments such as medications, medical devices, surgeries and rehabilitation; that demand, regulatory approvals and long-term care costs are what make the condition important to investors.

cell therapy medical

"perinatal tissue-derived cell therapy for chronic lower back pain"

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.

regenerative medicine medical

"a clinical-stage biotechnology company advancing regenerative medicine solutions"

A field of medical treatments that aims to repair, replace or regenerate damaged tissues and organs using approaches such as cell or gene therapies, engineered tissues, and biologically active materials. It matters to investors because successful regenerative therapies can create entirely new, high-value markets and replace chronic treatments, offering large potential returns but also long development timelines, heavy regulation and high technical risk—like betting on a promising new technology that could either revolutionize care or fail in trials.

AI-generated analysis. Not financial advice.

Data Show Strong Functional and Pain Improvements Supported by Excellent Safety Profile

PHOENIX, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) (“Creative Medical” or the “Company”), a clinical-stage biotechnology company advancing regenerative medicine solutions, today announced positive interim 180-day follow-up data from its FDA-cleared ADAPT clinical trial evaluating CELZ-201 (Olastrocel), the Company’s proprietary perinatal tissue-derived cell therapy for chronic lower back pain associated with degenerative disc disease.

The study produced statistically significant, clinically meaningful improvements in both functional disability (ODI%) and pain at primary trial end point, confirming durable human efficacy alongside an excellent safety profile.

The announcement of this data follows a previously announced study enrollment completion and positive independent Data Safety Monitoring Board (DSMB) safety review, which confirmed that CELZ-201(Olastrocel) demonstrated a favorable safety profile with no significant adverse events and supported continued advancement of the trial.

“We view this as a major corporate and clinical inflection point for Creative Medical, reflecting the transition of CELZ-201 (Olastrocel) from a clinical program into a promising strategic asset,” said Timothy Warbington, President and CEO. “Our focus is execution, data transparency, and unlocking the full value of this platform for patients and shareholders.”

Key Clinical Outcomes at Interim Analysis

• ODI% (Functional Disability): Mean improvement of −15.3 percentage points at 180 days (p = 0.0003; large effect size). Approximately 79% of patients achieved clinically meaningful functional improvement.
• Pain (0–10 Scale): Mean reduction of −3.9 points at 180 days (p < 0.00005; large effect size). Approximately 79% of patients achieved ≥2-point pain reduction.
• Safety: Independent DSMB review confirmed no serious adverse events and no treatment-related safety signals, remaining blinded 4:1 treatment: placebo.

Market Opportunity & Differentiation
Chronic lower back pain affects more than 16 million Americans and represents a multi-billion-dollar annual market. Current standards of care rely heavily on opioids, steroid injections, or invasive spine surgery, with limited durable solutions. CELZ-201 (Olastrocel) is an off-the-shelf, allogeneic regenerative cell therapy designed to deliver scalable, consistent, non-surgical, disease-modifying benefit.

Strategic Positioning & Next Catalysts
With safety de-risked and human efficacy signals, CELZ-201 (Olastrocel) is transitioning from execution risk to a data-driven value creation phase. The Company is advancing toward late-stage regulatory engagement, strategic partnership discussions, and commercialization planning awaiting final data.

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 interim results did CELZ (CELZ) announce for CELZ-201 on January 13, 2026?

CELZ reported 180-day interim results showing ODI −15.3 points (p=0.0003) and pain −3.9 points (p<0.00005), with ~79% meeting meaningful improvement.

How did the independent DSMB assess CELZ-201 safety in the ADAPT trial?

The independent DSMB confirmed no serious adverse events and no treatment-related safety signals at the interim review.

Does the January 13, 2026 CELZ ADAPT update mean CELZ-201 is approved?

No; the update describes positive interim clinical data and safety signals, but regulatory approval and final trial readout are still pending.

What are the next milestones for CELZ after the ADAPT interim data?

The company plans late-stage regulatory engagement, strategic partnership discussions, and commercialization planning pending final data.

How large is the target market CELZ cited for CELZ-201?

The company cited chronic lower back pain affecting more than 16 million Americans as the relevant market opportunity.