Creative Medical Technology Holdings Issues Letter to Shareholders
Creative Medical Technology Holdings (NASDAQ: CELZ) issued a shareholder letter outlining clinical, IP, and AI milestones that frame near-term catalysts for 2026. The company is advancing two FDA-cleared programs: CELZ-201-DDT (ADAPT) for degenerative disc disease with FDA Fast Track and topline results expected in H1 2026, and CELZ-201 (CREATE-1) for new-onset Type 1 Diabetes with early data expected in 2026. The firm reports > 6 billion cGMP clinical-grade AlloStem cells manufactured, an IP portfolio of > 60 patents/pending, and two U.S. patents issued in Q3 2025 (Type 1 Diabetes exp. 2043; Heart Failure exp. 2042). The company highlights AI integration for iPScelz and emphasizes capital discipline while targeting scalable commercialization paths.
Creative Medical Technology Holdings (NASDAQ: CELZ) ha pubblicato una lettera agli azionisti che descrive traguardi clinici, IP e IA che inquadrano catalizzatori a breve termine per il 2026. L'azienda sta avanzando su due programmi approvati dalla FDA: CELZ-201-DDT (ADAPT) per la degenerazione del disco con FDA Fast Track e risultati principali attesi nel PRIMO SEMESTRE 2026, e CELZ-201 (CREATE-1) per il diabete di tipo 1 in fase iniziale con dati preliminari attesi nel 2026. L'azienda riferisce oltre 6 miliardi di cellule AlloStem prodotte secondo GMP clinico, un portafoglio IP di oltre 60 brevetti/in attesa e due brevetti statunitensi concessi nel terzo trimestre del 2025 (Diabete di tipo 1 exp. 2043; insufficienza cardiaca exp. 2042). L'azienda evidenzia l'integrazione dell'IA per iPScelz e sottolinea la disciplina di capitale puntando a percorsi di commercializzazione scalabili.
Creative Medical Technology Holdings (NASDAQ: CELZ) ha emitido una carta a los accionistas que describe hitos clínicos, de PI e IA que enmarcan catalizadores a corto plazo para 2026. La empresa está avanzando con dos programas aprobados por la FDA: CELZ-201-DDT (ADAPT) para la enfermedad degenerativa de disco con FDA Fast Track y resultados principales esperados en H1 2026, y CELZ-201 (CREATE-1) para la diabetes tipo 1 de inicio reciente con datos tempranos esperados en 2026. La firma reporta > 6 mil millones de células AlloStem de grado clínico cGMP fabricadas, un portafolio de PI de > 60 patentes/en espera, y dos patentes estadounidenses concedidas en el 3er trimestre de 2025 (Diabetes tipo 1 exp. 2043; Insuficiencia cardíaca exp. 2042). La compañía destaca la integración de IA para iPScelz y enfatiza la disciplina de capital mientras apunta a rutas de comercialización escalables.
Creative Medical Technology Holdings (나스닥: CELZ)은 임상, 지식재산권 및 인공지능 이정표를 요약한 주주 서한을 발표했습니다. 이는 2026년의 단기 촉발 요인을 구성합니다. 회사는 FDA 승인 프로그램 두 가지를 진행 중입니다: CELZ-201-DDT (ADAPT)는 디스크 질환에 대해 FDA Fast Track을 받고, 상위 결과는 2026년 상반기에 예상되며, CELZ-201 (CREATE-1)은 신발견된 제1형 당뇨병으로 2026년에 초기 데이터가 기대됩니다. 업체는 임상 등급 cGMP AlloStem 세포를 60억 개 이상 제조했다고 보고하며, 특허 포트폴리오가 60개 이상이며, 2025년 3분기에 미국 특허 2건이 발급되었다고 밝힙니다(제1형 당뇨병 만료 2043; 심부전 만료 2042). 또한 iPScelz를 위한 AI 통합을 강조하고 자본 절제와 확장 가능한 상용화 경로를 목표로 한다고 언급합니다.
Creative Medical Technology Holdings (NASDAQ: CELZ) a publié une lettre aux actionnaires décrivant des jalons cliniques, de PI et d'IA qui encadrent des catalyseurs à court terme pour 2026. La société avance sur deux programmes approuvés par la FDA : CELZ-201-DDT (ADAPT) pour la maladie dégénérative discale avec FDA Fast Track et des résultats principaux attendus au 1er semestre 2026, et CELZ-201 (CREATE-1) pour le diabète de type 1 nouvellement apparu, avec des données précoces attendues en 2026. L’entreprise rapporte plus de 6 milliards de cellules AlloStem de grade clinique fabriquées sous cGMP, un portefeuille PI de plus de 60 brevets/demandes, et deux brevets américains délivrés au T3 2025 (Diabète de type 1 exp. 2043; Insuffisance cardiaque exp. 2042). Elle met en avant l’intégration de l’IA pour iPScelz et insiste sur une discipline financière tout en visant des voies de commercialisation évolutives.
Creative Medical Technology Holdings (NASDAQ: CELZ) hat einen Aktionärsbrief veröffentlicht, der klinische, IP- und KI-Meilensteine skizziert, die kurzfristige Catalysatoren für 2026 rahmen. Das Unternehmen treibt zwei FDA-bewilligte Programme voran: CELZ-201-DDT (ADAPT) für degenerative Bandscheibenkrankheit mit FDA Fast Track und erwarteten Endergebnissen im 1. HJ 2026, sowie CELZ-201 (CREATE-1) für neues Typ-1-Diabetes mit frühen Daten, die 2026 erwartet werden. Das Unternehmen meldet > 6 Milliarden klinisch GMP-konforme AlloStem-Zellen hergestellt, ein IP-Portfolio von > 60 Patenten/Anmeldungen und zwei US-Patente, die im Q3 2025 erteilt wurden (Typ-1-Diabetes Ablauf 2043; Herzinsuffizienz Ablauf 2042). Das Unternehmen hebt KI-Integration für iPScelz hervor und betont Kapitaldisziplin bei gleichzeitiger Ausrichtung auf skalierbare Vermarktungspfade.
Creative Medical Technology Holdings (المدرجة في ناسداك: CELZ) أصدرت رسالة للمساهمين توضح milestones سريرية وحقوق ملكية فكرية وذكاء اصطناعي تشكل محفزات قريبة المدى لعام 2026. الشركة تتقدم في برنامجين معتمَدين من إدارة الغذاء والدواء: CELZ-201-DDT (ADAPT) لمرض انزلاق الغضروف القطني مع FDA Fast Track ونتائج رئيسية متوقعة في النصف الأول من 2026، و CELZ-201 (CREATE-1) لمرض السكري من النوع الأول حديث الأولية مع بيانات مبكرة متوقعة في 2026. الشركة تقر بأن لديها أكثر من 6 مليارات خلية AlloStem مطورة وفق GMP سريرية، ومجموعة براءات IP لأكثر من 60 براءة محتملة، وببراءتين أمريكيتين صدرتا في الربع الثالث من 2025 (السكري من النوع الأول مُنتهٍ صلاحية 2043؛ فشل القلب صلاحية 2042). تبرز الشركة التكامل مع الذكاء الاصطناعي لـ iPScelz وتؤكد على الانضباط الرأسمالي مع التوجّه نحو مسارات تطوير تجارية قابلة للتوسع.
Creative Medical Technology Holdings（纳斯达克股票代码：CELZ） 发出股东信，概述临床、知识产权与人工智能里程碑，为2026年的短期催化剂定调。公司在推进两项已获FDA清晰的项目：CELZ-201-DDT（ADAPT）用于退行性椎间盘疾病，获得 FDA Fast Track，预计在 2026年上半年公布初步结果；以及 CELZ-201（CREATE-1）用于新发1型糖尿病，预计在 2026年有早期数据。公司报告已生产超 60亿 级别的 AlloStem 细胞，符合临床GMP标准，知识产权组合超过 60项专利/待审批，并在2025年第三季度获得两项美国专利（1型糖尿病专利到期2043年；心力衰竭专利到期2042年）。公司强调将AI整合到 iPScelz 中，并强调资本纪律，同时瞄准可扩展的商业化路径。
- Topline H1 2026 for CELZ-201-DDT (ADAPT)
- Early 2026 data expected for CELZ-201 (CREATE-1)
- >6 billion clinical-grade AlloStem cells manufactured
- 2 U.S. patents issued in Q3 2025 (expires 2042–2043)
- >60 patents and pending applications in IP portfolio
- None.
Insights
Clinical programs with FDA Fast Track, new patents, and AI work make this a materially positive operational update ahead of 2026 catalysts.
Creative Medical advances two FDA-cleared programs: a randomized Phase I/II AlloStem trial for degenerative disc disease with FDA Fast Track designation and topline results expected in the
Intellectual property and regulatory facts anchor the update: the portfolio totals over 60 patents and applications, and two U.S. patents issued in Q3 2025 cover ImmCelz claims for Type 1 Diabetes (expires
Monitorable items include topline readouts in
Ongoing Phase II Clinical Trials, Recently Issued Patents, and AI Integration Initiatives Set the Stage for Continuing Progress in 2026
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. | |
| IR@CreativeMedicalTechnology.com | |
| www.creativemedicaltechnology.com | |
| Investor Relations: | |
| Devin Sullivan, Managing Director | Dave Gentry |
| The Equity Group Inc. | RedChip Companies |
| dsullivan@equityny.com | 1-407-644-4256 |
| 1-800-REDCHIP (733-2447) | |
| CELZ@redchip.com | |
| Conor Rodriguez | |
| Associate | |
| crodriguez@equityny.com | |
FAQ
What clinical readouts is CELZ (Creative Medical) targeting in 2026?
What does CELZ's FDA Fast Track for CELZ-201-DDT mean for investors?
How large is Creative Medical's patent estate as of Q3 2025 for CELZ?
What manufacturing scale does Creative Medical report for AlloStem?
How does CELZ use AI in its iPScelz platform and what is the investor impact?
Does the shareholder letter address dilution or capital needs for CELZ (NASDAQ: CELZ)?
