PHOENIX, July 01, 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 issued a mid-year update from Timothy Warbington, President and CEO.

Dear Fellow Shareholder:

Creative Medical has entered the second half of 2026 with a strengthened clinical, regulatory, and strategic position across its core programs in chronic lower back pain, osteoarthritis ("OA"), immunotherapy, and biodefense.

This progress, combined with disciplined capital allocation and expanding non-dilutive opportunities, positions the Company for durable value creation on behalf of long-term shareholders.

The Company’s strategy is straightforward:

Advance Olastrocel (CELZ-201) toward Phase 3 readiness in chronic lower back pain.
Scale Ultrasome™, the Company’s cell-free osteoarthritis program, as a partner-ready asset.
Build the CELZ-Biodefense Toxic Exposure Atlas™ into a differentiated data and discovery platform with government and strategic collaboration potential.

Recent Clinical and Regulatory Milestones

Olastrocel (CELZ-201) – Spine Mobility and Pain Program (ADAPT Trial)

Late last year, the World Health Organization approved "Olastrocel" as the International Non-Proprietary Name for the active cellular substance in CELZ-201, the Company’s lead allogeneic cell therapy developed on the AlloStem^® platform.

This global naming milestone underscores the maturity and scalability of the program as the Company advances toward late-stage development.

In January, the Company reported positive interim blinded 180-day data from the FDA-cleared ADAPT clinical trial evaluating Olastrocel in chronic lower back pain associated with degenerative disc disease.

The trial demonstrated statistically significant improvements in disability and pain with no serious adverse events or treatment-related safety signals, as confirmed by an independent Data Safety Monitoring Board.

These findings support Olastrocel’s potential as a differentiated, durable regenerative therapy in a large, underserved patient population.

In June, the FDA cleared an expansion of the ADAPT trial to enroll an additional cohort of patients receiving less than 90 mg per day in morphine equivalents to further characterize safety and efficacy in individuals with ongoing opioid use.

The new cohort is already more than 85% enrolled and is supported by a patient-centric AI pain-medication monitoring system that captures real-time patient-reported outcomes and analgesic-use patterns.

Near-Term Olastrocel Priorities

Complete enrollment of the expanded ADAPT cohort and continue to generate longer-term follow-up data.
Advance regulatory interactions to align on Phase 3 planning for chronic lower back pain.
Evaluate strategic and partnering pathways as the dataset matures, with the objective of maximizing value while maintaining capital discipline.

Ultrasome™ – Cell-Free Osteoarthritis Program

In April, the Company announced breakthrough pilot results for Ultrasome™, its proprietary cell-free regenerative therapy for osteoarthritis of the knee, derived from the CELZ-201 platform.

The study achieved its primary endpoint, with 93% of patients demonstrating clinically meaningful improvements in mobility and pain reduction, and no serious adverse events reported.

These data support Ultrasome™ as an emerging, scalable, cell-free regenerative therapy targeting a high-volume market where current options often provide only transient relief.

Near-Term Ultrasome™ Priorities

Design and initiate the next stage of clinical development, with a focus on multi-center, controlled data generation to confirm and extend the pilot results.
Explore strategic pathways, including potential regional or indication-specific partnerships, to accelerate development and commercial planning while limiting dilutive capital needs.

CELZ-Biodefense Platform – Project PHOENIX and Toxic Exposure Atlas™

Earlier this year, the BioDefense Inc. Burn Pit Initiative received regulatory approval to proceed nationally, marking a major milestone in the mission to address the long-term health consequences of toxic burn pit exposure among U.S. veterans.

The program is being implemented without the need for new capital raises, leveraging existing strategic alliances, infrastructure, and vendor relationships, and exemplifying the Company’s commitment to capital efficiency.

In June, Project PHOENIX advanced into a nationwide, AI-enabled virtual data collection phase intended to scale to at least 1,000 veterans through mobile-app registry and field-capable logistics.

This initiative feeds into the proprietary CELZ-Biodefense Toxic Exposure Atlas™, which integrates exposure history, clinical outcomes, multi-omics datasets, cell-response information, and disease biology into a unified framework for AI-driven discovery.

Near-Term Biodefense Priorities

Complete initial enrollment and data ingestion for the first 1,000 veterans in the burn pit registry.
Advance AI-based modeling to identify exposure-linked molecular signatures and potential regenerative countermeasures using the Company’s stem cell and iPSC platforms.
Pursue government and strategic collaborations that recognize the Atlas as a differentiated data asset and help expand the platform into broader military and civilian populations.

Disciplined Capital Allocation and Value-Linked Financing

The Company’s approach to capital remains a central component of its strategy.

Creative Medical operates a lean corporate structure and is highly focused on investing in programs with clear paths to differentiation, regulatory advancement, and commercial or partnering potential.

The Company is not compelled to pursue dilutive or opportunistic financings simply to "keep the lights on." Instead, the intent is to align any future capital raises with well-defined, value-creating milestones, including:

Completion of key Olastrocel/ADAPT datasets and advancement toward Phase 3 planning.
Initiation and readout of next-stage Ultrasome™ studies in osteoarthritis of the knee.
Demonstration of initial AI-derived insights and partnership interest related to the CELZ-Biodefense Toxic Exposure Atlas™.

Where possible, the Company will prioritize non-dilutive and strategic funding sources, such as grants, collaborations, and program-level partnerships, in order to preserve shareholder value while scaling the platform.

Investment Thesis Snapshot

Creative Medical is building a multi-program, multi-platform company at the intersection of regenerative medicine, immunotherapy, and AI-enabled biodefense.

Its core pillars include:

Olastrocel (CELZ-201): Lead allogeneic cell therapy with WHO-approved naming, positive interim data in chronic lower back pain, and an FDA-cleared pathway toward expanded clinical evaluation and Phase 3 planning.
Ultrasome™ OA Program: Cell-free, scalable regenerative therapy with strong pilot response rates and a clear roadmap to multi-center development and strategic partnering in a large, underserved market.
CELZ-Biodefense Platform: Regulator-approved burn pit program and AI-enabled Toxic Exposure Atlas designed to generate one of the largest integrated datasets for toxic exposure, supporting future drug, biologic, biotherapeutic, and regenerative therapy discovery.

Across all programs, the Company is guided by three principles: data transparency, disciplined execution, and capital stewardship.

Continued delivery against clearly communicated milestones is expected to support durable value creation and help align the share price with the long-term potential of the Company’s platforms.

Closing

With a focused pipeline, encouraging clinical data, expanding regulatory validation, and a growing biodefense and AI footprint, the Company is optimistic about the path ahead.

Management remains deeply grateful for the ongoing support of shareholders and is committed to translating its innovations into therapies and platforms that can meaningfully improve patient lives while delivering sustainable value.

Respectfully submitted,

Timothy Warbington

Chief Executive Officer

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 CELZ-201 (Olastrocel) positioned as a lead clinical asset for chronic lower back pain and as the backbone for additional platform programs.

For more information, visit www.creativemedicaltechnology.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding, among other things, the safety and efficacy of CELZ-201 (Olastrocel), the progress of ongoing clinical trials, the design and impact of our BioDefense initiatives and the AI pain medication monitoring system, and the Company’s expectations regarding additional resource needs. These statements are based on current expectations, estimates and projections and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Risks and uncertainties include, but are not limited to, risks related to clinical trial conduct and outcomes, patient enrollment rates, regulatory review and feedback, manufacturing and supply, competition, macroeconomic conditions, capital markets, and the Company’s ability to execute its strategy. Additional information about these and other risk factors is contained in the Company’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K. The Company undertakes no obligation to update any forward-looking statements except as required by law.

Contact

Creative Medical Technology Holdings, Inc.

Investor Relations: IR@CreativeMedicalTechnology.com

Devin Sullivan, Managing Director - The Equity Group Inc.

Devin.Sullivan@theequitygroup.com

Conor Rodriguez, Associate - The Equity Group Inc.

Conor.Rodriguez@theequitygroup.com