CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.

Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company dedicated to the advancement of regenerative therapies in the fields of immunotherapy, endocrinology, urology, neurology and orthopedics. The company operates in the highly regulated biotechnology and regenerative medicine industry, where the FDA regulates the manufacture of human stem cell treatments under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. The industry is characterized by rapid changes in technology and customer demands, and the company's products and services may quickly become obsolete and unmarketable. The company faces competition from many pharmaceutical, biotechnology and medical device companies, as well as other private and public stem cell companies involved in the development and commercialization of cell-based medical technologies and therapies, many of which have substantially greater financial, technological, research and development, marketing and personnel resources.

The company's primary competitors named in the filing include Mesoblast, Longeveron, BioRestorative Therapies, and DiscGenics in the area of regenerative medicine for the disc and spine. The company's competitive advantages include its robust intellectual property portfolio composed of seven issued patents and thirty nine pending patent applications filed in the United States with the USPTO. The company's StemSpine procedure is protected by issued patents and is a U.S. registered trademark. The company's AlloStem (CELZ-201-DDT) received Fast Track designation from the FDA in August 2025, positioning it among a select group of therapies recognized for their potential to address serious medical conditions with high unmet need. The company also received Orphan Drug Designation from the FDA in March 2024 for the treatment of Brittle Type 1 Diabetes using its ImmCelz (CELZ-100) platform, providing tax advantages, user fee exemptions, and the opportunity for market exclusivity following approval.

The company generates revenue through the sale of disposable stem cell concentration kits, specifically its CaverStem and FemCelz disposable kits utilized by physicians to perform autologous procedures that treat erectile dysfunction and female sexual dysfunction, respectively. Revenues are recognized when control of the promised goods or services are transferred to the customer, which is generally on delivery. The company has generated minimal revenues from its products, with revenues of only $6,000 ¹ for the year ended December 31, 2025, and $11,000 ² for the year ended December 31, 2024. The company does not expect to generate revenues for the foreseeable future and will not achieve profitability unless it generates increased revenues from its current or proposed products or therapies. The company's business model also includes developing therapeutic platforms such as ImmCelz (CELZ-100), AlloStem (CELZ-201-DDT), and iPSCelz, which are in various stages of clinical development and have not yet been commercialized. The company currently conducts substantially all of its commercial operations through its subsidiary Creative Medical Technologies, Inc., which markets and sells the CaverStem and FemCelz disposable kits.

The company's pipeline includes AlloStem (CELZ-201-DDT), an allogenic human perinatal tissue derived cell program in clinical phase, which leverages a unique approach to harnessing the power of Perinatal Tissue Derived Cells with multi-potentialities including self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion. The company has 8 billion manufactured and validated cells available for clinical trials and further research ³. The ImmCelz (CELZ-100) platform is a personalized supercharged immune therapy platform in pre-clinical trials that utilizes a patient's own extracted immune cells that are then reprogrammed by culturing them outside the patient's body with optimized secreted factors. Independent studies showed the ImmCelz platform required 75% fewer donor patient cells compared to industry standard, the purity of the final product was greater than 95% compared to the industry standard of greater than 80%, and it demonstrated a greater than 200% reduction in functional suppression of effector T cells ⁴. The Type I Diabetes (CELZ-201 CREATE-1) program is a Phase I/IIa FDA study approved intervention for the treatment of recent onset Type 1 Diabetes, with subjects randomized to treatment or control groups in a 2:1 ratio, with 12 subjects in the treatment group and 6 in the control arm. The AlloStemSpine Chronic Lower Back Pain (CELZ-201 ADAPT) program is a Phase I/IIa FDA study approved double-blinded, randomized, placebo-controlled, dose escalation study to determine the safety, tolerability, and efficacy of CELZ-201-DDT administered as an intramuscular injection for the treatment of lower back pain in patients with Degenerative Disc Disease, enrolling 30 individuals. The StemSpine procedure uses the patient's own stem cells to reverse the effects of atherosclerosis and treat chronic lower back pain, with management determining it is exempt from FDA premarket review under Section 361 of the PHS Act. A pilot study of 15 patients showed the mean pain score changed from 8.9 at baseline to 4.3 at 30 days, sustained to 1.8 at 6 months and 1.3 at 12 months ⁵. Three-year follow-up data demonstrated continued efficacy with an efficacy rate of 87% of patients that participated in the pilot study ⁶. The CaverStem procedure is a clinically proven, patented procedure (U.S. Patent No. 8,372,797) that utilizes a patient's own stem cells to treat erectile dysfunction, geared to the estimated nine million men in the United States that suffer from ED and do not respond to PDE5 inhibitors ⁷. The company generated minimal revenues from this product in 2023 and 2024 and has paused marketing efforts. The FemCelz procedure for female sexual function treatment was launched in September 2018 and has not generated any revenues to date. The OvaStem technology is being developed for the treatment of female infertility, with positive three-year follow up data announced in July 2022 showing significant efficacy for the treatment of medical refractory Primary Ovarian Insufficiency without any serious adverse effects and the successful birth of healthy babies. The Alova program utilizes the AlloStem platform to treat infertility as a result of premature ovarian failure.

The company is also exploring the use of its technologies and has filed patents covering treatments for preventing the rejection of transplanted organs, kidney failure, liver failure, heart attack, and Parkinson's Disease. The company's patent portfolio is composed of seven issued patents and thirty nine pending patent applications filed in the United States with the USPTO. The issued patents include Treatment of Erectile Dysfunction by Stem Cell Therapy (Patent No. 8,372,797), Treatment Of Disc Degenerative Disease (Patent No. 9,598,673), Methods For Treatment Of Premature Ovarian Failure And Ovarian Aging Using Regenerative Cells (Patent No. 10,792,310), Paraspinal Perfusion by Administration of T regulatory Cells Alone or in Combination with Angiogenic Cell Therapies (Patent No. 10,842,815), Prevention And/Or Treatment Of Type 1 Diabetes By Augmentation Of Myeloid Suppressor Cell Activity (Patent No. 12,391,925), Generation of Autologous Immune Mcratiodulatory Cells for Treatment of Neurological Conditions (Patent No. 11,795,433), and Treatment Of Heart Failure And/Or Post Infarct Pathological Remodeling By Ex Vivo Reprogrammed Immune Cells (Patent No. 12,385,011). The company has obtained trademark registration for CaverStem, StemSpine, AlloStemSpine and FemCelz, and has trademark applications pending for ImmCelz, OvaStem, iPScelz, AlloStem, AlloStem Perinatal Tissue Derived Cells, and Alova.

During the fiscal year ended December 31, 2025, the company achieved several significant operational milestones. In January 2025, the company announced promising initial data from the first cohort of the CELZ-201 ADAPT clinical trial, with 10 participants (8 receiving CELZ-201-DDT and 2 receiving placebo) completing the study phase without any dose-limiting toxicities or serious adverse events. In February 2025, the company announced an expanded agreement with Greenstone Biosciences Inc. to leverage artificial intelligence in further developing its human induced pluripotent stem cell platform for diabetes treatment. In March 2025, the FDA cleared an expanded dose escalation for the ongoing Phase 1/2 trial of StemSpine using AlloStem (CELZ-201-DDT). In August 2025, the FDA granted Fast Track designation to CELZ-201-DDT. In October 2025, the company launched the BioDefense Veterans Initiative, a first-of-its-kind national program to combat the long-term effects of toxic burn pit exposure among U.S. service members. In November 2025, the company contributed $43,200 ⁸ to the capital of Bionance, which together with Mr. Warbington's contribution of $10,800 ⁹, was used to fund Bionance's $54,000 ¹⁰ investment in a convertible promissory note and warrants issued by Applife Digital Solutions, Inc. In December 2025, the company announced the successful completion of patient enrollment in the ADAPT clinical trial evaluating CELZ-201 (Olastrocel). On March 6, 2025, the company entered into warrant exercise inducement agreements for the exercise of outstanding warrants to purchase an aggregate of 837,104 ¹¹ shares of common stock at the exercise price of $4.42 ¹² per share, with aggregate gross proceeds of $3.7 million ¹³, and issued new warrants exercisable for an aggregate of up to 1,674,208 ¹⁴ shares of common stock at an exercise price of $3.75 ¹⁵ per share. On October 29, 2025, the company entered into warrant exercise inducement agreements for the exercise of outstanding warrants to purchase an aggregate of 1,116,136 ¹⁶ shares of common stock at the exercise price of $3.75 ¹⁷ per share, with aggregate gross proceeds of approximately $4.2 million ¹⁸, and issued new warrants exercisable for an aggregate of up to 2,790,340 ¹⁹ shares of common stock at an exercise price of $2.86 ²⁰ per share.

For the fiscal year ended December 31, 2025, the company generated total revenues of $6,000 ²¹, compared to $11,000 ²² in the prior year. Cost of goods sold was $2,194 ²³ versus $4,400 ²⁴ in the prior year. Gross profit was $3,806 ²⁵ compared to $6,600 ²⁶ in the prior year. The company reported an operating loss of $6,142,814 ²⁷ for the year ended December 31, 2025, compared to $5,743,861 ²⁸ for the prior year. Net loss attributable to CMTH was $5,995,008 ²⁹ for the year ended December 31, 2025, compared to $5,493,481 ³⁰ for the prior year. Diluted net loss per share was $2.52 ³¹ for 2025 versus $3.71 ³² for 2024. Research and development expenses totaled $2,259,796 ³³ for 2025 compared to $2,400,777 ³⁴ for 2024. Selling, general and administrative expenses totaled $3,763,497 ³⁵ for 2025 compared to $3,239,232 ³⁶ for 2024. Interest income was $147,806 ³⁷ for 2025 compared to $250,380 ³⁸ for 2024. As of December 31, 2025, the company had cash of $7,208,126 ³⁹ and positive working capital of approximately $7,114,134 ⁴⁰, compared to cash of $5,940,402 ⁴¹ and positive working capital of approximately $5,807,659 ⁴² as of December 31, 2024.

The company states that as a result of its recent warrant exercise transactions, it believes it will have sufficient cash to meet its anticipated operating costs and capital expenditure requirements through at least March 2027 ⁴³. The company anticipates that it will need to raise additional capital in the future to support its ongoing operations and continue its clinical trials, and expects to continue to raise additional capital through the sale of its securities from time to time for the foreseeable future.

A major growth vector is the AlloStem (CELZ-201-DDT) platform, which the company believes has multiple applications including its ImmCelz immunotherapy platform for multiple diseases, OvaStem for Premature Ovarian Failure, Type I Diabetes (CELZ-201 CREATE-1), and AlloStemSpine Chronic Lower Back Pain (CELZ-201 ADAPT). The company has 8 billion manufactured and validated cells available for clinical trials and further research ⁴⁴. The Type I Diabetes (CELZ-201 CREATE-1) clinical trial is a Phase I/II study with the primary objective to evaluate CELZ-201 treatment in patients with newly diagnosed Type 1 Diabetes, with patient recruitment initiated in September 2023. The AlloStemSpine Chronic Lower Back Pain (CELZ-201 ADAPT) clinical trial is a double-blinded, randomized, placebo-controlled, dose escalation Phase 1/2a study enrolling 30 individuals suffering from chronic lower back pain. In January 2025, the first cohort of 10 participants completed the study phase without any dose-limiting toxicities or serious adverse events, and the DSMB recommended the trial proceed to the next cohort. In December 2025, the company announced the successful completion of patient enrollment in the ADAPT clinical trial, enabling the program to transition into its next phase focused on follow-up and data analysis. The FDA granted Fast Track designation to CELZ-201-DDT in August 2025, which enables the company to benefit from accelerated FDA interactions, rolling Biologics License Application submissions, and eligibility for priority review, potentially expediting the path to market and patient access.

Another growth vector is the ImmCelz (CELZ-100) platform, which the company is developing for the treatment of multiple indications. The company received Orphan Drug Designation from the FDA in March 2024 for the treatment of Brittle Type 1 Diabetes using its ImmCelz platform, providing tax advantages, user fee exemptions, and the opportunity for market exclusivity following approval. The company is also developing its iPSCelz program in partnership with Greenstone Biosciences Inc., which in June 2024 successfully generated human induced pluripotent stem cell-derived islet cells that produce human insulin. In February 2025, the company expanded its agreement with Greenstone to leverage artificial intelligence in further developing its human induced pluripotent stem cell platform for diabetes treatment, aiming to identify small molecules that enhance insulin secretion and implement multi-gene editing to develop next generation hypoimmune iPSC lines. The company also launched the BioDefense Veterans Initiative in October 2025, a national program to combat the long-term effects of toxic burn pit exposure among U.S. service members, with Greenstone as the exclusive AI and iPSC development partner. The company is also exploring the use of its technologies for additional indications including preventing the rejection of transplanted organs, kidney failure, liver failure, heart attack, and Parkinson's Disease.

The filing does not provide specific margin trajectory, cost structure evolution, or efficiency targets. Research and development expenses decreased by $140,981 ⁴⁵ or 6% from $2,400,777 ⁴⁶ in 2024 to $2,259,796 ⁴⁷ in 2025, primarily due to the CELZ-201-ADAPT spine trial completing recruitment and dosing and going into follow-up visits, and timing in the development of the iPSC cell line in partnership with Greenstone Biosciences Inc. Selling, general and administrative expenses increased by $524,265 ⁴⁸ or 16% from $3,239,232 ⁴⁹ in 2024 to $3,763,497 ⁵⁰ in 2025, primarily due to increases of $349,363 ⁵¹ in salaries tied to timing of bonus payments, $229,650 ⁵² in increased marketing expenses, and $50,717 ⁵³ in timing of general liability insurance payments, offset by an $89,475 ⁵⁴ decrease in D&O insurance premiums.

The company currently employs four people on a full-time basis and multiple consultants on a part-time basis. The company's corporate office is located at 211 East Osborn Road, Phoenix, Arizona, which it leases on a month-to-month basis. The company relies on contract research organizations, academic institutions, corporate partners, and other third parties to assist in managing, monitoring, and otherwise carrying out clinical trials and research activities. The company relies upon third parties for the manufacture of its CaverStem and FemCelz disposable kits. The company has limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals and has relied, and expects to continue to rely, in part, on consultants and third-party contract research organizations with expertise in this area.

Research and development expenses for the year ended December 31, 2025, totaled $2,259,796 ⁵⁵, reflecting expenses associated with laboratory research, the Lower Back Pain Phase I/II clinical trial, the manufacturing and testing of the ImmCelz cell line, and the development of the iPSC cell line in partnership with Greenstone Biosciences Inc. The company's share repurchase program, authorized on June 12, 2023, allows for the repurchase of up to $2 million ⁵⁶ of common stock. To date, the company has repurchased 106,250 ⁵⁷ shares of common stock under the Repurchase Plan for an aggregate purchase price of $455,916 ⁵⁸. There were no repurchases of common stock by the company in the three months ended December 31, 2025. The company has never declared or paid any cash dividends on its common stock and does not anticipate paying any cash dividends in the foreseeable future. The company currently intends to retain all available funds and any future earnings for use in the operation of its business.

The company has incurred recent losses and its future profitability is uncertain. The company incurred an operating loss of approximately $6.1 million ⁵⁹ for the year ended December 31, 2025, and a loss of approximately $5.7 million ⁶⁰ for the year ended December 31, 2024. The company expects its operating losses to continue until such time, if ever, that product sales, licensing fees, royalties and other sources generate sufficient revenue to fund its operations. For the year ended December 31, 2025, the company's operations used approximately $5.9 million ⁶¹ in cash. At December 31, 2025, the company had a combined cash and short-term U.S. treasuries balance of approximately $7.2 million ⁶². Although the company generated gross proceeds in excess of $40 million ⁶³ from its 2021, 2022, 2024, and 2025 securities offerings, it will need additional capital to maintain its operations, continue its research and development programs, conduct clinical trials, seek regulatory approvals and manufacture and market its products. The company cannot be certain that adequate additional funding will be available on acceptable terms, if at all.

The company faces significant regulatory and commercialization risks. The company's product candidates' commercial viability remains subject to current and future preclinical studies, clinical trials, regulatory approvals, and the risks generally inherent in the development of biopharmaceutical products. The company has limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including FDA approval. The company will require FDA approval of CELZ-201 CREATE-1 for the treatment of Type I diabetes, AlloStemSpine (CELZ 201 – ADAPT) treatment for chronic lower back pain, and other indications. The company's autologous products (CaverStem and FemCelz) are currently not eligible for reimbursement from public or private insurers and are paid for by patients. The company's existing and proposed products are and will be subject to substantial pricing, reimbursement, and access pressures from state Medicaid programs, private insurance programs and pharmacy benefit managers, and the implementation of U.S. health care reform legislation. The company also faces competition from established pharmaceutical and biotechnology companies with significantly greater financial resources and expertise.

The company has incurred an operating loss of approximately $6.1 million ⁶⁴ for the year ended December 31, 2025, and a loss of approximately $5.7 million ⁶⁵ for the year ended December 31, 2024, and expects operating losses to continue until product sales, licensing fees, royalties and other sources generate sufficient revenue to fund operations. Revenues generated from sales of CaverStem kits were only $6,000 ⁶⁶ and $11,000 ⁶⁷ for the years ended December 31, 2025 and 2024, respectively, and the company does not expect to generate revenues for the foreseeable future. The company will need additional capital to fund operations as planned, with operations using approximately $5.9 million ⁶⁸ in cash for the year ended December 31, 2025, and a combined cash and short-term U.S. treasuries balance of approximately $7.2 million ⁶⁹ at December 31, 2025. The company's product candidates' commercial viability remains subject to current and future preclinical studies, clinical trials, and regulatory approvals, and the company has limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals. The company's autologous products are currently not eligible for reimbursement from public or private insurers and are paid for by patients, limiting the addressable market to those who can afford to pay directly.

Management's message to shareholders emphasizes the company's transition to a commercial stage biotechnology company with a robust pipeline of regenerative therapies. The forward-looking statements in the filing indicate that management believes the company will have sufficient cash to meet its anticipated operating costs and capital expenditure requirements through at least March 2027 ⁷⁰ as a result of recent warrant exercise transactions. Management anticipates that the company will need to raise additional capital in the future to support ongoing operations and continue clinical trials, and expects to continue to raise additional capital through the sale of securities from time to time for the foreseeable future. The strategic priorities emphasized by management include advancing the AlloStem (CELZ-201-DDT) platform through clinical trials, particularly the CELZ-201 ADAPT and CELZ-201 CREATE-1 trials; developing the ImmCelz (CELZ-100) platform and iPSCelz program in partnership with Greenstone Biosciences Inc.; and pursuing regulatory milestones such as the Fast Track designation for CELZ-201-DDT and the Orphan Drug Designation for the ImmCelz platform. Management also highlights the importance of the company's intellectual property portfolio, consisting of seven issued patents and thirty nine pending patent applications, and the company's proprietary Master Cell Bank and Drug Master File for AlloStem.