Creative Medical Technology Holdings Issues Letter to Shareholders
PHOENIX, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) ("Creative Medical" or the "Company"), a clinical-stage biotechnology company pioneering regenerative immunotherapy, today issued a Letter to Shareholders from Timothy Warbington, Co-Founder and Chief Executive Officer.
Dear Fellow Shareholders:
2025 has been a landmark year for Creative Medical. With the support of the most comprehensive clinical, intellectual, and technological foundation in our Company's history, we have evolved from proof-of-concept to clinical trials in support of our mission to develop breakthrough regenerative stem cell therapies across multiple indications.
At the same time, we are pursuing new and exciting areas of clinical research that leverage our proprietary cellular platforms - AlloStem™, ImmCelz™, and iPScelz™ - and position Creative Medical as an active participant in this new era of regenerative medicine. Breakthroughs in biology, Artificial Intelligence (AI), and scalability are converging to unlock unprecedented value for patients and shareholders alike. We are well positioned to capitalize on these opportunities with a business model that is faster, more efficient, and significantly more versatile than traditional single-cell approaches.
THREE PLATFORMS. ONE DISRUPTIVE ENGINE
Unlike conventional biotech firms built around a single product, Creative Medical's diversified platform strategy provides multiple shots on goal across vast therapeutic frontiers. Our approach is designed to expand market reach while de-risking development and maximizing long-term shareholder returns.
- AlloStem: Our FDA-cleared, off-the-shelf, donor-derived perinatal tissue technology represents a paradigm shift in regenerative treatment. With over 6 billion clinical-grade cells manufactured under cGMP, AlloStem is ready to scale immediately across multiple indications.
- ImmCelz: A groundbreaking personalized immunotherapy that reprograms a patient's own immune cells to unleash regenerative potential. The ImmCelz process activates immune intelligence, unlocking pathways that can accelerate healing and suppress harmful inflammation.
- iPScelz: Our next-generation induced pluripotent stem cell (iPSC) platform, derived from AlloStem, provides a limitless renewable source for creating replacement cell types across a spectrum of degenerative diseases.
Together, these platforms form a self-sustaining ecosystem of regenerative innovation, an engine capable of generating high-value programs, strategic licensing, and global partnerships.
CLINICAL TRIALS UNDERWAY: DRIVING TOWARDS TRANSFORMATIONAL DATA IN 2026
Creative Medical is advancing two pivotal FDA-cleared clinical programs that target multi-billion-dollar markets and represent major potential near-term catalysts.
- CELZ-201-DDT (ADAPT Trial): Targeting chronic lower back pain caused by degenerative disc disease, a market estimated at approximately $11 billion annually. This randomized, placebo-controlled Phase I/II trial has received FDA Fast Track Designation and is designed to validate AlloStem's potential to regenerate and remodel disc tissue. Topline results are anticipated in the first half of 2026.
- CELZ-201 (CREATE-1 Trial): Focused on new-onset Type 1 Diabetes, a condition with a global treatment market estimated at $35 billion annually. This study targets the autoimmune root cause of the disease rather than symptom management, a radical shift in treatment philosophy. Recruitment is accelerating across multiple sites, with early data expected in 2026.
Both trials leverage the same AlloStem foundation, maximizing cost efficiency and scalability.
INTELLECTUAL PROPERTY: BUILDING A FORTRESS AROUND INNOVATION
Creative Medical's technology is protected by a strong IP portfolio currently comprised of over 60 patents and pending applications. In Q3 2025, we secured two cornerstone U.S. patents expanding ImmCelz coverage to Type 1 Diabetes (expires 2043) and Heart Failure (expires 2042). These patents validate our core science and strategically lock in long-term exclusivity across two of the highest-value markets in global healthcare. Our patented biology aligns with mechanisms recognized by the 2025 Nobel Prize® in Physiology or Medicine. This portfolio forms the foundation of our partnership strategy and enhances our ability to negotiate from strength in any future collaborations or licensing discussions.
AI-ENHANCED REGENERATION: WHERE BIOLOGY MEETS INTELLIGENCE
Creative Medical's integration of AI into our iPScelz platform represents, in our view, a significant advance in the evolution of regenerative medicine. Our proprietary AI models are designed to accelerate target discovery, optimize donor cell selection, and simulate in vivo behavior before clinical testing, saving time, reducing cost, and improving precision.
By harnessing AI to decode cellular behavior and patient-specific responses, Creative Medical is pioneering the future of personalized regenerative medicine - the ability to engineer treatments that are uniquely matched to individual patients. This fusion of data science and stem cell technology positions Creative Medical as a leader in what analysts call ‘Regenerative Medicine 2.0.'
FINANCIAL STRENGTH, CAPITAL EFFICIENCY, AND STRATEGIC READINESS
We continue to operate with financial discipline and operational agility. Each investment is strategically directed toward high-return milestones. With multiple potential value-driving events expected in the next 12 months, we remain mindful of the capital that shareholders have entrusted to us and our goal is to build sustainable growth without excessive dilution. Our team remains laser-focused on executing the most value-accretive path for shareholders, while maintaining the lean efficiency that defines Creative Medical's competitive advantage.
A CLEAR FOCUS FOR THE FUTURE
We are not simply developing treatments; we are focused on redefining what is possible in regenerative medicine. Our science is validated, our platforms are scalable, and our vision is clear. As we enter this next exciting phase of our development, we are committed to delivering measurable, long-term shareholder value.
Respectfully submitted,
Timothy Warbington
Chief Executive Officer
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) is a clinical-stage biotechnology company pioneering regenerative medicine solutions across multiple indications. The Company leverages cutting-edge cell therapy technologies to develop transformative treatments aimed at improving patient outcomes.
Forward-Looking Statements
This news release may contain forward-looking statements, including, but not limited to, statements regarding the development and commercialization of the Company's therapies, market opportunities, clinical progress, and the strength of the Company's intellectual property portfolio. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties are detailed in the Company's periodic reports filed with the U.S. Securities and Exchange Commission (SEC) and available at www.sec.gov. The Company undertakes no obligation to update forward-looking statements except as required by law.
Nobel Prize® is a registered trademark of the Nobel Foundation; use herein is for identification only and does not imply any affiliation or endorsement.
| Contact: | |
| Creative Medical Technology Holdings, Inc. | |
| [email protected] | |
| www.creativemedicaltechnology.com | |
| Investor Relations: | |
| Devin Sullivan, Managing Director | Dave Gentry |
| The Equity Group Inc. | RedChip Companies |
| [email protected] | 1-407-644-4256 |
| 1-800-REDCHIP (733-2447) | |
| [email protected] | |
| Conor Rodriguez | |
| Associate | |
| [email protected] | |
