Creative Medical Technology Holdings Receives Regulatory Approval for BioDefense Burn Pit Initiative

Rhea-AI Summary

Creative Medical Technology Holdings (NASDAQ: CELZ) announced regulatory approval on January 6, 2026 for its BioDefense Inc. Burn Pit Initiative, allowing the program to proceed nationally to collect expanded molecular and cellular data from veterans affected by burn pit exposure.

The company said no additional fundraising is required; the program will be funded using existing partnerships (including Greenstone Biosciences), internal infrastructure, and prior vendor relationships to support AI-driven molecular modeling, iPSC development, and regenerative countermeasure work.

Positive

• Regulatory approval granted to proceed with Burn Pit Initiative (Jan 6, 2026)
• Program funded without additional fundraising, reducing dilution risk
• Leverages existing partnership with Greenstone Biosciences
• Uses proprietary iPSC and AI platforms for regenerative countermeasures
• Initiative builds a national molecular and cellular veteran database

Negative

• None.

Market Reality Check

$2.45 Last Close

Volume Volume 45,152 is below the 20-day average of 81,411, suggesting a modest pre-news positioning. low

Technical Price at $2.04 is trading below the 200-day MA of $2.72, reflecting a longer-term downtrend.

Peers on Argus 1 Up 1 Down

CELZ was up 3.55% ahead of this positive regulatory update, while key biotech peers showed mixed moves, with names like ERNA and RNAZ up modestly and others such as INAB and NLSP down, pointing to a stock‑specific rather than sector‑wide driver.

Common Catalyst Several biotech peers also had development-focused news (trial progress and preclinical data), but price action appears idiosyncratic rather than a coordinated sector rotation.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 17	Trial enrollment complete	Positive	+1.2%	Completed enrollment in FDA-cleared ADAPT trial for CELZ-201 in back pain.
Dec 2	INN naming milestone	Positive	-11.8%	WHO approved ‘olastrocel’ as INN for lead allogeneic cell therapy CELZ-201.
Oct 30	BioDefense launch	Positive	-13.0%	Launched BioDefense veterans initiative using iPSC platform and AI analytics.
Oct 29	Warrant financing	Negative	-32.7%	Warrant exercises and new warrants for $4.2M gross proceeds, adding dilution risk.
Oct 27	Shareholder letter	Positive	+5.4%	Outlined CELZ-201 clinical, IP and AI milestones and 2026 catalysts.

Pattern Detected

CELZ has shown mixed reactions to news: some positive clinical and strategic updates aligned with gains, while others, particularly financing and certain biodefense milestones, coincided with sharp selloffs, indicating inconsistent sentiment around long-term dilution and new initiatives.

Recent Company History

Over the last few months, CELZ advanced multiple programs. On Oct 27, 2025, a shareholder letter highlighted two FDA‑cleared CELZ‑201 trials with Fast Track status and significant AlloStem manufacturing scale. Subsequent warrant inducement agreements on Oct 29 and related filings added funding but also dilution concerns. The company then launched its burn pit BioDefense initiative on Oct 30, followed by WHO INN recognition for olastrocel on Dec 2 and completion of ADAPT trial enrollment on Dec 17. Today’s regulatory clearance for the Burn Pit Initiative extends that biodefense trajectory without new fundraising.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-11-21

An effective S-3 shelf dated Nov 21, 2025 registers 2,790,340 shares for resale upon warrant exercise. The company will not sell shares directly through this shelf, but secondary sales by existing holders over time could weigh on the share price if large blocks enter the market.

Market Pulse Summary

The stock moved +9.3% in the session following this news. A strong positive reaction aligns with CELZ’s history of rewarding key clinical and strategic milestones, such as its shareholder letter and ADAPT enrollment, which saw gains of 5.43% and 1.2%. However, prior warrant-related financings and the active S-3 resale shelf highlight ongoing dilution and overhang risk. Investors monitoring sustainability would watch future warrant exercises, secondary sales from the registered 2,790,340 shares, and execution progress across BioDefense and CELZ‑201 programs.

Key Terms

induced pluripotent stem cell medical

"using its proprietary induced pluripotent stem cell (iPSC) platform and analytical"

Cells taken from an adult (such as skin or blood) that scientists ‘reprogram’ so they behave like versatile early-stage cells capable of becoming many different cell types in the body. For investors, these cells matter because they enable development of personalized therapies, safer and faster drug testing, and potential regenerative treatments—like resetting a gadget to factory mode so it can run many different apps—creating new commercial opportunities and affecting biotech valuation and risk.

iPSC medical

"using its proprietary induced pluripotent stem cell (iPSC) platform and analytical"

Induced pluripotent stem cells (iPSCs) are ordinary adult cells that scientists have reprogrammed back into a versatile, embryonic-like state so they can become many different cell types. Think of them as factory-reset cells that can be turned into heart, nerve, or blood cells for testing drugs, modeling diseases, or developing cell therapies. For investors, iPSCs signal potential high-reward opportunities in new treatments and research tools but also carry technical, manufacturing and regulatory risks that affect commercial prospects.

genomic medical

"Decoding genomic and proteomic signatures of toxic exposureModeling disease"

Relating to an organism’s genome — the complete set of DNA instructions that determine traits and biological functions — and to the study or use of that information. For investors, genomic technologies and data underpin diagnostics, targeted medicines, and personalized treatments, shaping potential market size, product timelines, and regulatory risk; think of it as reading an instruction manual to design precise medical products, which can speed innovation but also bring scientific and approval uncertainty.

proteomic medical

"Decoding genomic and proteomic signatures of toxic exposureModeling disease"

Proteomic describes something related to the large-scale study of proteins—the working parts inside cells that carry out functions and signal changes. For investors, proteomic work can reveal new drug targets, diagnostic tests or biomarkers that change a company’s potential revenue and risk profile; think of it like analyzing all ingredients in a recipe to find which ones can be improved or swapped to make a better product.

machine learning technical

"Modeling disease progression pathways using machine learningDeveloping iPSC-based"

Machine learning is a set of computer programs that learn patterns from large amounts of data and improve their predictions or decisions over time, like a recipe that gets better each time it’s adjusted based on taste tests. For investors it matters because these systems can speed up analysis, spot trends or risks humans might miss, automate routine work, and potentially create competitive advantages or cost savings that affect a company’s performance.

regenerative medicine medical

"a clinical-stage biotechnology company advancing regenerative medicine and AI-enabled"

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.

biodefense medical

"advancing regenerative medicine and AI-enabled biodefense solutions, today announced"

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.

molecular modeling technical

"initiate expanded data collection, AI-driven molecular modeling, and regenerative"

Molecular modeling is the use of computer programs to build and simulate the shapes and behaviors of molecules so researchers can predict how they will interact, change, or bind to other substances. For investors, it matters because these virtual tests can speed up discovery, reduce lab costs and help assess whether a drug, material or chemical process is likely to work before costly experiments, offering early signals about a project's technical risk and timeline.

AI-generated analysis. Not financial advice.

PHOENIX, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) (“Creative Medical” or the “Company”), a clinical-stage biotechnology company advancing regenerative medicine and AI-enabled biodefense solutions, today announced that its BioDefense Inc. Burn Pit Initiative has received regulatory approval to proceed, marking a significant milestone in the Company’s mission to address the long-term health consequences of toxic burn pit exposure among U.S. military veterans.

Importantly, the Company also confirmed that no additional fundraising is required to execute this initiative, as the program will be supported through existing strategic partnerships, infrastructure, and previously established vendor relationships, resulting in meaningful cost efficiencies.

Regulatory Clearance Accelerates National Burn Pit Program

The newly granted regulatory approval enables BioDefense Inc., a wholly owned subsidiary of Creative Medical, to formally advance its Burn Pit Program, which is designed to build one of the most comprehensive molecular and cellular databases ever assembled for veterans affected by burn pit–related toxic exposure. With this clearance, the Company may now initiate expanded data collection, AI-driven molecular modeling, and regenerative countermeasure development using its proprietary induced pluripotent stem cell (iPSC) platform and analytical technologies.

“This regulatory approval represents a defining inflection point for our BioDefense strategy,” said Timothy Warbington, President and Chief Executive Officer of Creative Medical. “It allows us to move forward with a program that directly serves U.S. veterans while also establishing a scalable national capability in regenerative biodefense.”

Capital-Efficient Execution: No New Fundraising Required

Creative Medical emphasized that the current Burn Pit Initiative will be executed without the need for additional capital raises, reflecting disciplined financial stewardship and strategic leveraging of existing relationships.

Key contributors to this cost-efficient approach include:

• Long-standing collaboration agreements already in place with Greenstone Biosciences, Inc.
• Utilization of previously established AI, sequencing, and iPSC development frameworks
• Internalized intellectual property and proprietary regenerative platforms
• Favorable commercial terms secured through prior strategic planning

“As a result of our existing infrastructure and partnerships, this initiative does not introduce incremental balance sheet pressure,” Warbington added. “We believe this disciplined approach differentiates Creative Medical among emerging biotech companies and reinforces our commitment to shareholder value.”

AI-Integrated Regenerative Biodefense Platform

Through BioDefense Inc., Creative Medical is advancing an AI-enabled regenerative defense platform capable of:

• Decoding genomic and proteomic signatures of toxic exposure
• Modeling disease progression pathways using machine learning
• Developing iPSC-based regenerative repair strategies
• Supporting future deployment across both military and civilian populations

The Burn Pit Initiative is expected to serve as a foundational program within a broader biodefense framework that may be extended to additional exposure-related and environmental health threats.

About Creative Medical Technology Holdings, Inc.

Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is a clinical-stage biotechnology company advancing regenerative medicine, immune modulation, and induced pluripotent stem cell (iPSC) technologies. The Company’s platform supports therapeutic programs in autoimmune, inflammatory, neurological, metabolic, and biodefense indications, integrating cellular regeneration with AI-driven analytics to enhance national and population health resilience.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding regulatory approvals, anticipated program execution, cost efficiencies, and future development plans. Actual results may differ materially due to risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission. Creative Medical undertakes no obligation to update forward-looking statements except as required by law.

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 January 6, 2026 about the Burn Pit Initiative?

Creative Medical announced regulatory approval to proceed with its BioDefense Burn Pit Initiative and said no additional fundraising is required to execute the program.

How will Creative Medical (CELZ) fund the Burn Pit Initiative without new capital?

The company said it will use existing partnerships, infrastructure, and vendor relationships, including collaboration with Greenstone Biosciences.

What capabilities will the BioDefense Burn Pit Program use under Creative Medical (CELZ)?

The program will use AI-driven molecular modeling, sequencing, and iPSC-based regenerative platforms to build a veteran-focused database and develop countermeasures.

Does Creative Medical (CELZ) plan national deployment of the Burn Pit program?

Yes; regulatory clearance enables the company to advance a national Burn Pit Program and expand data collection and modeling efforts.

Will the Burn Pit Initiative affect Creative Medical's (CELZ) balance sheet?

The company stated the initiative does not introduce incremental balance sheet pressure because it relies on existing resources and favorable commercial terms.