Executive Summary / Key Takeaways

• Creative Medical Technology Holdings (CELZ) is a clinical-stage biotechnology company focused on developing novel regenerative and cellular therapies across multiple therapeutic areas, including immunotherapy, endocrinology, urology, neurology, and orthopedics.
• The company's core investment thesis centers on its innovative cell-based platforms, such as ImmCelz, AlloStem, and iPScelz, which are advancing through clinical trials and leveraging strategic partnerships, including the integration of AI for accelerated drug discovery and biodefense applications.
• Recent operational milestones include FDA clearances for Phase III clinical trials in Type 1 Diabetes (CELZ-201 CREATE-1) and chronic lower back pain (AlloStemSpine CELZ-201 ADAPT), positive initial safety and efficacy data from the ADAPT trial, and the receipt of Orphan Drug Designation for Brittle Type 1 Diabetes.
• Financially, CELZ operates with minimal revenue, reporting a net loss of $4.11 million for the nine months ended September 30, 2025, reflecting its heavy investment in research and development. The company has recently bolstered its liquidity through warrant exercises, raising approximately $7.50 million in net proceeds in 2025 to fund its pipeline.
• Key factors for investors to monitor include the progression and outcomes of ongoing clinical trials, the successful commercialization of its advanced therapeutic platforms, and the effective leverage of its technological differentiators, particularly in the competitive and capital-intensive biotechnology landscape.

The Genesis of Innovation: Setting the Stage for Regenerative Medicine

Creative Medical Technology Holdings, Inc. (CELZ) stands at the forefront of regenerative medicine, a clinical-stage biotechnology company dedicated to identifying and translating novel biological therapeutics. Its journey began in 1998 as Jolley Marketing, Inc., but a pivotal recapitalization and reverse merger in 2016 transformed it into Creative Medical Technology Holdings, Inc., aligning its corporate identity with an ambitious focus on biotechnology. This strategic pivot laid the groundwork for its current multi-platform approach, encompassing immunotherapy, endocrinology, urology, neurology, and orthopedics.

The company's foundational commercial operations are conducted through its subsidiary, Creative Medical Technologies, Inc. (CMT), which markets and sells CaverStem and FemCelz disposable kits for erectile dysfunction and female sexual dysfunction, respectively. While these products represent its current revenue-generating arm, the core of CELZ's long-term strategy and investment appeal lies in its advanced development platforms: ImmCelz, StemSpine, AlloCelz, and iPScelz. These platforms are designed to harness the power of reprogrammed stem cells and immune cells to address a wide array of debilitating diseases.

In the highly competitive biotechnology sector, CELZ positions itself as a specialized innovator, often contrasting with larger, more diversified players. Companies like Vericel Corporation , MiMedx Group, Inc. , and Mesoblast Limited operate in similar regenerative medicine spaces, often with more established commercial footprints and broader product portfolios. CELZ's strategic response to this landscape involves a focused pursuit of niche, condition-specific treatments, aiming to differentiate itself through superior technological performance and targeted biological mechanisms. This approach, while potentially leading to stronger efficacy in specific areas, necessitates significant investment in research and development, often resulting in minimal revenue and substantial net losses during the clinical development phase.

Technological Edge: The Heart of CELZ's Strategy

CELZ's investment thesis is deeply rooted in its proprietary technological platforms, which offer distinct advantages in the complex field of regenerative medicine. The company's commitment to innovation is evident in its core technologies and ongoing research initiatives.

The ImmCelz (CELZ-100) platform represents a significant technological differentiator. This platform utilizes a patient's own extracted immune cells, which are then "supercharged" by culturing them outside the body with optimized stem cells or cell-free factors before re-injection. This process is believed to endow immune cells with regenerative properties suitable for treating multiple indications. Independent studies have validated several tangible benefits of ImmCelz: it requires 75% fewer donor patient cells compared to industry standards, achieves a purity greater than 95% (surpassing the industry standard of over 80%), and demonstrated a greater than 200% reduction in functional suppression of effector T cells, a critical concern for autoimmune conditions, while maintaining a high number of functional T regulatory cells. These performance metrics suggest the potential for substantially reduced production costs and the manufacture of a superior clinical product, which could accelerate clinical applications and foster collaborations.

Another cornerstone of CELZ's technological roadmap is the iPScelz program, developed in partnership with Greenstone Biosciences Inc. This collaboration focuses on creating a human induced pluripotent stem cell (iPSC) pipeline. The successful development of a viral-free iPSC cell line is estimated to save the company two to three years in research and development time and associated expenses. This iPSC line holds immense potential for differentiation into therapeutic biologics for both cellular and cell-free programs, as well as targeted drug discovery.

Furthermore, the AlloStem Clinical Cell Line (CELZ-200) is a proprietary allogenic cell line, including a Master Cell Bank and a Drug Master File. This versatile cell line is intended for use across multiple programs, including ImmCelz immunotherapy, OvaStem for Premature Ovarian Failure, Type I Diabetes (CELZ-201 CREATE-1), and AlloStemSpine (CELZ-201 ADAPT). The ability to leverage a single, well-characterized allogenic cell line across various therapeutic applications streamlines development and potentially reduces costs.

The "so what" for investors is clear: these technological differentiators are designed to create a competitive moat for CELZ. The improved efficiency and purity of ImmCelz could lead to lower manufacturing costs and potentially higher efficacy, translating into better margins and stronger market adoption upon commercialization. The accelerated R&D timelines and broad applicability of iPScelz and AlloStem enhance the company's ability to bring multiple therapies to market faster, strengthening its long-term growth strategy and market positioning against competitors who may rely on less efficient or more costly development pathways.

Clinical Progress and Strategic Expansion

CELZ's strategic initiatives are heavily concentrated on advancing its pipeline through clinical development and expanding its technological applications. The company has achieved several significant milestones that underscore its progress.

In November 2022, the FDA cleared the Investigational New Drug (IND) application for Type I Diabetes (CELZ-201 CREATE-1), allowing CELZ to initiate a Phase III clinical trial, with patient recruitment commencing in September 2023. This represents a critical step towards addressing a significant unmet medical need. Further demonstrating its leadership in diabetes treatment, the company secured FDA authorization in March 2024 for an expanded access therapy using CELZ-201 to potentially prevent Type I Diabetes onset in high-risk individuals, a development believed to be a medical first. The ImmCelz CELZ-100 platform also received Orphan Drug Designation (ODD) from the FDA in March 2024 for the treatment of Brittle Type 1 Diabetes, which provides substantial benefits including tax advantages, user fee exemptions, and the opportunity for market exclusivity following approval.

The StemSpine platform has also shown promising results. In February 2023, positive three-year follow-up data from its pilot study for chronic lower back pain demonstrated continued efficacy without any serious adverse effects. Building on this, CELZ received FDA clearance in September 2023 to initiate a Phase III clinical trial for AlloStemSpine Chronic Lower Back Pain (CELZ-201 ADAPT). This "first in country study" aims to enroll 30 individuals and evaluate the safety, efficacy, and tolerability of AlloStem CELZ-201-DDT, delivered via a minimally invasive ultrasound-guided procedure that avoids radiation exposure. Initial data from the first cohort of the CELZ-201 ADAPT trial in January 2025 confirmed an excellent safety profile with no dose-limiting toxicities or serious adverse events, and blinded preliminary data suggested encouraging therapeutic potential in alleviating back pain and restoring functionality. The Data Safety Monitoring Board (DSMB) has since recommended the trial proceed to the next cohort.

A significant strategic expansion for CELZ is the BioDefense Inc. Veterans Initiative, officially launched in October 2025. This program combines artificial intelligence (AI) with the company's proprietary iPSC technology to diagnose and treat U.S. veterans exposed to toxic burn pits. The initiative, spearheaded by BioDefense Inc., a subsidiary of Creative Medical, aims to create one of the largest molecular-level databases of veteran toxic exposure to develop precision regenerative countermeasures. This program leverages the predictive capabilities of AI to identify damage and utilize validated iPSCelz, ImmCelz CELZ-100, and/or AlloStem CELZ-201-DDT to develop optimized therapeutic options. The use of AI is expected to strengthen research efficiency, precision, and innovation in drug discovery, accelerating the identification of potential targets and optimizing biological screenings. This initiative, in partnership with Greenstone Biosciences Inc. as the exclusive AI and iPSC development partner, positions CELZ as a cornerstone of national medical readiness and veteran health security.

Financial Performance and Liquidity: Fueling the Pipeline

As a clinical-stage biotechnology company heavily invested in research and development, Creative Medical Technology Holdings operates with minimal revenue and consistently reports net losses. For the nine months ended September 30, 2025, the company generated $3,000 in revenue, a decrease from $8,000 in the comparable period of 2024. This resulted in a gross profit of $1,800 for the nine-month period in 2025, down from $4,800 in the prior year.

The company's operational focus is reflected in its expense structure. Selling, general, and administrative (SG&A) expenses for the nine months ended September 30, 2025, totaled $2.40 million, an increase of 30% from $1.85 million in the prior year. This rise was primarily driven by a $288,122 increase in marketing expenses and $191,478 associated with the timing of bonus payouts. Research and development (R&D) expenses for the same period were $1.71 million, an 11% decrease from $1.93 million in 2024. This decrease was primarily due to a $454,432 reduction in general research and a $164,729 decrease in expenses for the Type I Diabetes (CELZ-201 CREATE-1) clinical trial, partially offset by a $166,193 increase in the AlloStemSpine Chronic Lower Back Pain (CELZ-201 ADAPT) trial as patient recruitment and dosing continued, and a $233,340 increase in clinical research fees.

The net effect of these activities was an operating loss of $4.20 million for the nine months ended September 30, 2025, compared to $3.86 million a year ago. After accounting for other income, primarily interest income which decreased due to lower short-term investment balances, the net loss for the nine months ended September 30, 2025, was $4.11 million, compared to a net loss of $3.64 million in the prior year. The net loss per share for the nine months ended September 30, 2025, was $1.72, compared to $2.59 in the prior year, reflecting an increased weighted average number of shares outstanding.

Maintaining adequate liquidity is paramount for a company in CELZ's stage of development. As of September 30, 2025, the company reported $5.38 million in available cash and US Treasuries, with a positive working capital of approximately $5.15 million. Net cash used in operating activities for the nine months ended September 30, 2025, was $3.92 million, an increase of 17% from $3.35 million in the comparable period of 2024, primarily due to increased R&D investments, corporate marketing, and employee bonus payouts.

To fund its operations and ongoing clinical trials, CELZ has actively engaged in financing activities. The company received $3.35 million in net proceeds from the exercise of warrants during the nine months ended September 30, 2025. This was further bolstered by a warrant exercise inducement offer that closed on March 6, 2025, generating approximately $3.70 million in net proceeds, and a subsequent offer that closed on October 25, 2025, yielding approximately $3.80 million in net proceeds. These capital raises are crucial for supporting working capital and general corporate purposes, enabling the continued advancement of its pipeline.

Competitive Dynamics and Risk Considerations

Creative Medical Technology Holdings operates within a dynamic and intensely competitive biotechnology landscape. While its specialized focus on adult stem cell therapies offers potential advantages, it faces formidable competition from both direct and indirect rivals. Direct competitors like Vericel Corporation (VCEL), MiMedx Group, Inc. (MDXG), and Mesoblast Limited (MESO) often possess greater financial resources, more extensive commercial infrastructures, and broader product portfolios. For instance, Vericel has an established market presence in orthopedic applications, while MiMedx leverages a robust distribution network for its tissue-based products. Mesoblast, with its advanced pipeline and global partnerships, represents a significant player in cellular medicines for inflammatory and degenerative diseases.

CELZ's competitive strategy hinges on its technological differentiators, such as the efficiency and purity of its ImmCelz platform, which could lead to superior patient outcomes and potentially lower treatment costs compared to some alternatives. However, its smaller operational scale and earlier stage of commercialization mean it lags behind these larger competitors in terms of consistent revenue generation and profitability. This disparity in financial health can impact CELZ's ability to invest in R&D at the same pace or to build out extensive marketing and sales operations, which are critical for successful product launches.

Indirect competition also comes from traditional pharmaceutical companies offering synthetic drugs or non-stem cell biologics, as well as emerging gene editing technologies. These alternatives could present more accessible or easier-to-implement treatments, potentially impacting CELZ's market share and profitability.

The company's outlook is also shaped by several inherent risks. Its limited operating history and minimal revenues expose it to significant financial uncertainties. The biotechnology industry is characterized by rapid technological changes, meaning CELZ's products and services could quickly become obsolete if it fails to adapt. Technical or other difficulties could delay or prevent the development and marketing of new products, and the company may face capital resource constraints for further development. Furthermore, global economic conditions and geopolitical conflicts could adversely affect its operations and financial results. The success of CELZ's investment thesis is therefore contingent on its ability to successfully navigate these competitive pressures and mitigate these risks through continued innovation, successful clinical trial outcomes, and strategic capital management.

Conclusion

Creative Medical Technology Holdings (NASDAQ:CELZ) is carving out a distinct position in the burgeoning field of regenerative medicine, driven by its innovative cell-based platforms and a strategic embrace of artificial intelligence. The company's journey, marked by a transformative pivot to biotechnology, has culminated in a robust pipeline of therapies targeting significant unmet medical needs in areas such as Type 1 Diabetes and chronic lower back pain. Its technological differentiators, including the high efficiency and purity of ImmCelz and the versatile AlloStem Clinical Cell Line, coupled with the strategic integration of AI through initiatives like the BioDefense Inc. Veterans Initiative, represent the core of its long-term growth potential.

While CELZ's current financial performance reflects the substantial investment required for clinical-stage development, with minimal revenues and ongoing net losses, its ability to secure capital through warrant exercises demonstrates a capacity to fund its ambitious pipeline. The progression of its Phase III clinical trials and the promising initial safety and efficacy data from the AlloStemSpine ADAPT trial are critical indicators of its potential to translate scientific innovation into commercial success. As CELZ continues to advance its therapeutic candidates and leverage its technological leadership, particularly in AI-driven drug discovery and personalized medicine, it aims to differentiate itself in a competitive landscape. For discerning investors, CELZ represents a high-risk, high-reward opportunity, where the successful execution of its clinical programs and the realization of its technological advantages could unlock significant value in the evolving regenerative medicine market.