Clinical Trials and Research - The company has received FDA clearance for the Type I Diabetes (CELZ-201 CREATE-1) IND application, allowing the initiation of a Phase I/II clinical trial [80]. - In April 2023, the company reported a 93% overall efficacy in a study of 30 patients treated with CELZ-001 for Type 2 Diabetes, demonstrating at least a 50% reduction in insulin requirement [84]. - The ImmCelz™ (CELZ-100) platform requires 75% fewer donor patient cells compared to industry standards, with a final product purity greater than 95% [86]. - The company has successfully generated human induced pluripotent stem cells (iPSCs)-derived islet cells that produce human insulin, indicating potential for clinical translation [88]. - The company initiated a program combining AI with its proprietary iPSC to diagnose and treat patients exposed to biological and chemical weapons, enhancing research efficiency and innovation [89]. - The company completed dosing the second cohort of 10 patients in the CELZ-201 ADAPT clinical trial, with no dose-limiting toxicities reported [91]. - The company has filed for Orphan Drug Designation for the treatment of Brittle Type 1 Diabetes using its ImmCelz™ platform, receiving the designation in March 2024 [83]. - The AlloStemSpine® Chronic Lower Back Pain trial will enroll 30 individuals, evaluating safety, efficacy, and tolerability of the treatment [85]. - The company has expanded its development and acquisition of intellectual property beyond urology to include treatments for neurologic disorders and other diseases [76]. Financial Performance - There was no revenue generated for the three-month periods ended September 30, 2025, and 2024 [96]. - No gross profits were reported for the three-month periods ended September 30, 2025, and 2024 [100]. - General and administrative expenses for the three-months ended September 30, 2025, totaled $776,821, an increase of $278,214 or 56% compared to the same period last year [101]. - Research and development expenses for the three-months ended September 30, 2025, totaled $465,154, a decrease of $116,642 or 20% from the previous year [103]. - The operating loss for the three-months ended September 30, 2025, was $1,273,034, compared to $1,109,674 for the same period last year [104]. - The net loss for the three-months ended September 30, 2025, was $1,235,934, compared to a net loss of $1,040,135 for the same period last year [105]. - Gross revenue for the nine-months ended September 30, 2025, was $3,000, down from $8,000 for the comparable period last year [107]. - General and administrative expenses for the nine-months ended September 30, 2025, totaled $2,396,735, an increase of $550,558 or 30% compared to the previous year [109]. - Research and development expenses for the nine-months ended September 30, 2025, totaled $1,709,719, a decrease of $219,218 or 11% from the previous year [111]. - The operating loss for the nine-months ended September 30, 2025, was $4,197,032, compared to $3,858,127 for the same period last year [112]. - The net cash used in operating activities for the nine-months ended September 30, 2025, was $3,918,891, an increase of $567,135 or 17% from the previous year [115].

Core Viewpoint - Creative Medical Technology Holdings, Inc. (CELZ) has experienced a bearish trend, losing 49% in stock price over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with reduced selling pressure, suggesting that bulls may be gaining control [2][5]. - A hammer pattern forms when there is a small candle body with a long lower wick, typically occurring during a downtrend, indicating a potential reversal if it appears at the bottom of the trend [4][5]. - The effectiveness of the hammer pattern is enhanced when used alongside other bullish indicators, as its strength is dependent on its placement on the chart [6]. Fundamental Analysis - There has been a notable upward trend in earnings estimate revisions for CELZ, which is a bullish indicator, as it often correlates with price appreciation [7]. - Over the last 30 days, the consensus EPS estimate for CELZ has increased by 32.3%, indicating strong agreement among analysts that the company will report better earnings than previously predicted [8]. - CELZ holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9][10].

Core Insights - Creative Medical Technology Holdings, Inc. has launched the BioDefense Inc. Veterans Initiative to address the long-term effects of toxic burn pit exposure among U.S. service members [1][2] - The initiative aims to position Creative Medical as a key player in America's biodefense infrastructure, utilizing proprietary iPSC and regenerative technologies alongside AI analytics [2][7] Group 1: Initiative Overview - The BioDefense Inc. initiative is believed to be a first-of-its-kind national program focused on combating the health impacts of toxic exposure for veterans [1] - The program will create a large molecular-level database of veteran toxic exposure, serving as a foundation for precision regenerative therapies [3][9] Group 2: Technological Collaboration - Greenstone Biosciences has been selected as the exclusive AI and iPSC development partner to enhance the initiative [4] - The partnership will leverage advanced molecular-sequencing and machine-learning algorithms to analyze data from service members exposed to burn pits [5][6] Group 3: Goals and Objectives - The initiative aims to develop predictive disease modeling systems for both military and civilian populations [6] - It seeks to decode the genomic and proteomic architecture of toxic-exposure-related injuries and engineer iPSC-based regenerative repair models [9]

Core Points - Creative Medical Technology Holdings, Inc. has entered into agreements for the immediate exercise of existing warrants to purchase up to 1,116,136 shares of common stock at an exercise price of $3.75 per share, expected to generate approximately $4.2 million in gross proceeds [1][4] - The company will issue new unregistered warrants for an aggregate of up to 2,790,340 shares at the same exercise price, with potential adjustments based on the lowest VWAP during a specified period [3] - The transaction is anticipated to close on or about October 29, 2025, subject to customary closing conditions, with proceeds intended for working capital and general corporate purposes [4] Financial Advisory - Roth Capital Partners is acting as the financial advisor for this transaction [2] Regulatory Compliance - The new warrants were offered in a private placement and have not been registered under the Securities Act of 1933, with the company agreeing to file a registration statement with the SEC for the resale of shares [5]

Core Insights - Creative Medical Technology Holdings, Inc. has made significant advancements in 2025, transitioning from proof-of-concept to clinical trials for regenerative stem cell therapies across multiple indications [1][2] - The company is leveraging proprietary cellular platforms, including AlloStem™, ImmCelz™, and iPScelz™, to position itself as a leader in regenerative medicine, capitalizing on breakthroughs in biology and AI [2][3] - Creative Medical's diversified platform strategy allows for multiple therapeutic approaches, enhancing market reach and reducing development risks [3][4] Clinical Trials - The company is advancing two pivotal FDA-cleared clinical programs targeting multi-billion-dollar markets, which are expected to serve as major near-term catalysts [5][6] - The trials utilize the AlloStem foundation, maximizing cost efficiency and scalability [6] Intellectual Property - Creative Medical boasts a strong intellectual property portfolio with over 60 patents and pending applications, including two cornerstone U.S. patents secured in Q3 2025 for ImmCelz, covering Type 1 Diabetes and Heart Failure [7] - These patents validate the company's core science and provide long-term exclusivity in high-value healthcare markets [7] AI Integration - The integration of AI into the iPScelz platform represents a significant advancement in regenerative medicine, aimed at accelerating target discovery and optimizing donor cell selection [8] - By utilizing AI to decode cellular behavior, the company is pioneering personalized regenerative medicine, enhancing treatment precision [9] Financial Strategy - The company operates with financial discipline, focusing investments on high-return milestones while maintaining a lean operational structure [9] - Multiple potential value-driving events are anticipated in the next 12 months, with a commitment to sustainable growth without excessive dilution [9] Future Focus - Creative Medical is dedicated to redefining possibilities in regenerative medicine, with validated science, scalable platforms, and a clear vision for long-term shareholder value [10]

Core Insights - Creative Medical Technology Holdings, Inc. has received two U.S. patents for its ImmCelz™ platform, focusing on treatments for Type 1 Diabetes and heart failure, leveraging supercharged Regulatory T cells [2][3] - The recent Nobel Prize awarded to researchers in Treg science highlights the significance of the company's research focus and its potential impact on regenerative immunotherapy [1][3] Patent Details - U.S. Patent Number 12931925B2, expiring on May 24, 2043, covers the prevention and treatment of Type 1 Diabetes through the enhancement of myeloid suppressor cell activity [2] - U.S. Patent Number 12385011B2, expiring on December 15, 2042, pertains to the treatment of heart failure and post-infarct pathological remodeling using ex vivo reprogrammed immune cells [2] Market Potential - The heart failure treatment program targets over five million patients in the U.S. at risk of heart failure, with an additional six million patients suffering from refractory angina potentially eligible for treatment [3] - The Type 1 diabetes program supports a broad, cell-based immunotherapy approach validated with cells from Type 1 diabetes patients, aligning with the ongoing CREATE-1 clinical trial [4] Technology Overview - The ImmCelz™ platform reprograms a patient's immune cells outside the body, enhancing them with optimized cell-free factors before reintroducing them, aiming to facilitate tissue repair rather than merely suppressing symptoms [5][6] - This innovative approach positions the company to address high-burden medical conditions where immune over-activation and tissue damage are prevalent [5] Company Profile - Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company focused on developing regenerative medicine solutions across various indications, utilizing advanced cell therapy technologies to improve patient outcomes [7]

Core Insights - The U.S. FDA has granted Fast Track designation to Creative Medical Technology Holdings' investigational therapy CELZ-201-DDT for treating degenerative disc disease (DDD), which is a significant cause of chronic lower back pain and disability [1][2]. Company Overview - Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, targeting unmet needs in various medical fields including neurology, urology, orthopedics, and autoimmune diseases [7]. Product Details - CELZ-201-DDT is an allogeneic perinatal cell therapy delivered through minimally invasive, ultrasound-guided intramuscular injections, showing a favorable safety profile and early signs of efficacy in clinical trials [3][4]. - The therapy is part of the proprietary AlloStem platform and aims to address the underlying cellular degeneration and inflammation associated with DDD [3][5]. Market Potential - The global spinal disorders treatment market is projected to exceed $20 billion by 2030, indicating substantial commercial opportunities for innovative therapies like CELZ-201-DDT [5]. Regulatory and Development Strategy - Fast Track designation allows the company to benefit from accelerated FDA interactions, rolling Biologics License Application submissions, and eligibility for priority review, potentially speeding up the path to market [2][4]. - The company plans to publicly post its expanded access policy for CELZ-201-DDT within 15 days of the announcement, in compliance with federal regulations [6].

PART I – FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements and related disclosures for Creative Medical Technology Holdings, Inc [Item 1. Financial Statements](index=1&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Creative Medical Technology Holdings, Inc., including the Balance Sheets, Statements of Operations, Statements of Cash Flows, and Statements of Stockholders' Equity (Deficit), along with their accompanying notes, providing a snapshot of the company's financial position and performance for the periods ended June 30, 2025, and December 31, 2024 [Unaudited Condensed Consolidated Balance Sheets](index=2&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :------------------ | | **ASSETS** | | | | Cash | $6,544,120 | $5,940,402 | | Total Current Assets | $6,632,707 | $6,135,303 | | Licenses, net | $469,240 | $530,559 | | TOTAL ASSETS | $7,105,228 | $6,669,143 | | **LIABILITIES & EQUITY** | | | | Total Current Liabilities | $277,644 | $327,644 | | TOTAL LIABILITIES | $277,644 | $327,644 | | TOTAL STOCKHOLDERS' EQUITY | $6,827,584 | $6,341,499 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $7,105,228 | $6,669,143 | [Unaudited Condensed Consolidated Statements of Operations](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) This section outlines the company's financial performance, including revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024 | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenues | $ - | $ 8,000 | $ 3,000 | $ 8,000 | | Gross profit | $ - | $ 4,800 | $ 1,800 | $ 4,800 | | Research and development | $ 501,261 | $ 924,749 | $ 1,244,565 | $ 1,347,141 | | Selling, general and administrative | $ 731,517 | $ 676,086 | $ 1,619,914 | $ 1,347,570 | | TOTAL EXPENSES | $ 1,263,520 | $ 1,630,106 | $ 2,925,798 | $ 2,753,253 | | Operating loss | $ (1,263,520) | $ (1,625,306) | $ (2,923,998) | $ (2,748,453) | | Interest income | $ 30,217 | $ 67,578 | $ 52,598 | $ 149,181 | | NET LOSS | $ (1,233,303) | $ (1,557,728) | $ (2,871,400) | $ (2,599,272) | | NET LOSS PER SHARE - BASIC AND DILUTED | $ (0.48) | $ (1.11) | $ (1.26) | $ (1.84) | | WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | 2,580,532 | 1,405,208 | 2,282,290 | 1,413,324 | [Unaudited Condensed Consolidated Statements of Cash Flows](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $ (2,871,400) | $ (2,599,272) | | Net cash used in operating activities | $ (2,750,282) | $ (2,366,168) | | Net cash provided by investing activities | $ - | $ 6,520,191 | | Net cash provided by (used in) financing activities | $ 3,354,000 | $ (149,414) | | NET INCREASE IN CASH | $ 603,718 | $ 4,004,609 | | ENDING CASH BALANCE | $ 6,544,120 | $ 7,471,476 | [Unaudited Condensed Consolidated Statements of Stockholder' Equity (Deficit)](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholder'%20Equity%20(Deficit)) This section presents changes in the company's equity, including common stock, additional paid-in capital, and accumulated deficit, for the period ended June 30, 2025 | Metric | December 31, 2024 | June 30, 2025 | | :-------------------------- | :---------------- | :-------------- | | Common Stock Shares | 1,748,428 | 2,585,532 | | Common Stock Amount | $1,749 | $2,586 | | Additional Paid-in Capital | $70,931,663 | $74,298,311 | | Accumulated Deficit | $(64,591,913) | $(67,463,313) | | Treasury Stock | $ - | $(10,000) | | Total Stockholders' Equity | $6,341,499 | $6,827,584 | - The company's total stockholders' equity increased from **$6,341,499** at December 31, 2024, to **$6,827,584** at June 30, 2025, primarily due to proceeds from the exercise of warrants (**$3,700,000**) offset by a net loss of **$2,871,400** and treasury stock purchases (**$10,000**)[16](index=16&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanatory notes accompanying the financial statements, offering further context on accounting policies, agreements, and equity changes [NOTE 1 – ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=5&type=section&id=NOTE%201%20%E2%80%93%20ORGANIZATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note describes the company's business, operational segment, limited operating history, and key accounting policies for revenue recognition and net loss per share - Creative Medical Technology Holdings, Inc. is a commercial-stage biotechnology company focused on novel biological therapeutics in immunotherapy, endocrinology, urology, neurology, and orthopedics. It conducts commercial operations through CMT, marketing CaverStem® and FemCelz® kits for erectile and female sexual dysfunction[20](index=20&type=chunk)[22](index=22&type=chunk) - The company manages its operations as one reportable segment, with the CEO acting as the Chief Operating Decision Maker (CODM) who reviews and manages the business at a consolidated level[24](index=24&type=chunk) - The company has a limited operating history and minimal revenues, facing risks related to general economic conditions, limited marketing capabilities, rapid technological changes, and capital resource constraints for product development[27](index=27&type=chunk)[29](index=29&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk) - Revenue is recognized from the sale of disposable stem cell concentration kits upon transfer of control to customers, typically on delivery. Deferred revenue was **$0** as of June 30, 2025, down from **$40,000** at December 31, 2024[33](index=33&type=chunk)[34](index=34&type=chunk) - Basic and diluted net loss per share calculations exclude common stock equivalents (options and warrants) during loss periods as they are anti-dilutive. For the six months ended June 30, 2025, **4,147,478 warrants** and **11,183 options** were anti-dilutive[36](index=36&type=chunk) [NOTE 2 – LICENSING AGREEMENTS](index=6&type=section&id=NOTE%202%20%E2%80%93%20LICENSING%20AGREEMENTS) This note details the company's patent licensing agreements, including amortization schedules and carrying values for various intellectual properties Patent Amortization and Carrying Values (as of June 30, 2025) | Patent | Expiration | Amortization (6 months ended June 30, 2025) | Carrying Value (June 30, 2025) | | :------------------------------------------ | :--------- | :------------------------------------------ | :----------------------------- | | ED Patent | 2025 | $4,986 | $6,083 | | Multipotent Amniotic Fetal Stem Cells License | Feb 2026 | $586 | $275 | | Lower Back Patent (Initial) | May 2027 | $5,267 | $19,733 | | Lower Back Patent (Additional $300k) | 2026 | $22,970 | $41,524 | | Lower Back Patent (IND Filing $100k) | 2033 | $5,119 | $79,055 | | Lower Back Patent (First Patient Dosing $200k) | 2034 | $9,912 | $185,049 | | ImmCelz™ Patent | 2030 | $12,479 | $137,521 | Licensing Agreements Rollforward (Six Months Ended June 30, 2025) | Metric | Assets | Accumulated Amortization | | :-------------------------- | :------- | :----------------------- | | Balances at December 31, 2024 | $1,060,000 | $(529,441) | | Amortization | $ - | $(61,319) | | Balances at June 30, 2025 | $1,060,000 | $(590,760) | [NOTE 3 – RELATED PARTY TRANSACTIONS](index=8&type=section&id=NOTE%203%20%E2%80%93%20RELATED%20PARTY%20TRANSACTIONS) This note discloses transactions with related parties, specifically the CEO's purchase and redemption of Series B Preferred Stock for voting purposes - On **May 14, 2024**, the CEO purchased **one share** of Series B Preferred Stock for **$100**, which carried **100,000,000 votes** on a specific Share Increase Proposal. This share was automatically redeemed upon approval of the proposal on **December 9, 2024**[54](index=54&type=chunk) [NOTE 4 – STOCK-BASED COMPENSATION](index=8&type=section&id=NOTE%204%20%E2%80%93%20STOCK-BASED%20COMPENSATION) This note outlines the company's stock-based compensation plan, including outstanding options and related expenses - The 2021 Equity Incentive Plan authorized **60,000 shares** for awards. As of June 30, 2025, **11,183 stock options** were outstanding with an average exercise price of **$83.96** and a remaining life of **6.61 years**. No options were issued, exercised, or expired during the six months ended June 30, 2025[55](index=55&type=chunk)[58](index=58&type=chunk) - Stock-based compensation expense for the six-month periods ended June 30, 2025 and 2024 was **$3,485**. All stock-based compensation has been expensed as of June 30, 2025[58](index=58&type=chunk) [NOTE 5 – STOCKHOLDERS' EQUITY](index=8&type=section&id=NOTE%205%20%E2%80%93%20STOCKHOLDERS'%20EQUITY) This note details changes in stockholders' equity, including share repurchases and warrant exercise inducement offers - The Board approved a share repurchase program on **June 12, 2023**, authorizing up to **$2 million** in common stock repurchases. During the six months ended June 30, 2025, the company repurchased **5,000 shares** for **$10,000**, recorded as treasury stock[60](index=60&type=chunk) - On **March 6, 2025**, the company entered into warrant exercise inducement offer letters, resulting in the exercise of **837,104 existing warrants** at **$4.42/share** and the issuance of **1,674,208 new inducement warrants** at **$3.75/share**. This transaction generated approximately **$3.7 million** in net proceeds for working capital[61](index=61&type=chunk)[62](index=62&type=chunk) Warrant Activity (Six Months Ended June 30, 2025) | Metric | Warrants | Weighted Average Exercise Price | | :-------------------------- | :------- | :------------------------------ | | Outstanding, December 31, 2024 | 3,184,808 | $20.30 | | Issuances | 1,799,774 | $3.75 | | Exercises | (837,104) | $4.42 | | Outstanding, June 30, 2025 | 4,147,478 | $16.32 | [NOTE 6 – SUBSEQUENT EVENTS](index=9&type=section&id=NOTE%206%20%E2%80%93%20SUBSEQUENT%20EVENTS) This note confirms the absence of material subsequent events after the reporting period - There were no material subsequent events reported after June 30, 2025[66](index=66&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=9&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations for the three and six months ended June 30, 2025, compared to the prior year. It covers an overview of the company's biotechnology platforms and recent developments, detailed financial performance, liquidity, capital resources, and critical accounting policies [Forward-Looking Statement Notice](index=9&type=section&id=Forward-Looking%20Statement%20Notice) This section advises readers that the report contains forward-looking statements subject to risks and uncertainties, and the company disclaims any obligation to update them - The report contains forward-looking statements regarding product development, business, financial condition, and strategies, which are subject to risks and uncertainties that could cause actual results to differ materially from expectations[68](index=68&type=chunk)[69](index=69&type=chunk) - The company disclaims any obligation to update or revise forward-looking statements to reflect events or circumstances arising after the report date[71](index=71&type=chunk) [Overview](index=10&type=section&id=Overview) This section provides a high-level summary of Creative Medical Technology Holdings, Inc.'s business as a commercial-stage biotechnology company and highlights key developments in its therapeutic platforms - Creative Medical Technology Holdings, Inc. is a commercial-stage biotechnology company focused on novel biological therapeutics across immunotherapy, endocrinology, urology, neurology, and orthopedics[72](index=72&type=chunk) - The company's commercial operations are primarily through Creative Medical Technologies, Inc. (CMT), which monetizes intellectual property related to erectile dysfunction (ED) and has expanded into 're-programmed' stem cell treatments for various disorders[74](index=74&type=chunk) - Key developments include: [ImmCelz™ Platform Development](index=10&type=section&id=ImmCelz%E2%84%A2%20Platform%20Development) This section details the development and advancements of the ImmCelz™ platform, including its efficacy improvements and Orphan Drug Designation for Brittle Type 1 Diabetes - ImmCelz™ (CELZ-100) platform develops treatments using 'reprogrammed' patient immune cells for multiple indications, demonstrating improved purity (**>95%**), reduced donor cell requirements (**75% fewer**), and enhanced functional suppression of effector T cells (**>200% reduction**) compared to industry standards[75](index=75&type=chunk)[89](index=89&type=chunk) - In **March 2024**, ImmCelz™ (CELZ-100) received Orphan Drug Designation (ODD) from the FDA for treating Brittle Type 1 Diabetes, offering benefits like tax advantages, user fee exemptions, and market exclusivity[81](index=81&type=chunk) [iPSCelz™ Program and AI Integration](index=10&type=section&id=iPSCelz%E2%84%A2%20Program%20and%20AI%20Integration) This section describes the progress of the iPScelz™ program, including viral-free iPSC line development, insulin-producing islet cells, and AI integration for drug discovery - The iPScelz™ program, in collaboration with Greenstone Biosciences Inc., successfully developed a viral-free human induced pluripotent stem cell (iPSC) line, saving **2-3 years** in R&D and showing potential for therapeutic biologics and drug discovery[76](index=76&type=chunk) - In **June 2024**, the company successfully generated human iPSCs-derived islet cells that produce human insulin, with potential for clinical translation and stand-alone insulin production[86](index=86&type=chunk) - In **July 2024**, a program was initiated to combine AI with proprietary iPSCs for diagnosing and treating patients exposed to biological and chemical weapons, aiming to accelerate research efficiency, precision, and innovation in drug discovery and therapeutic interventions[87](index=87&type=chunk) [AlloStem™ Clinical Cell Line Development](index=10&type=section&id=AlloStem%E2%84%A2%20Clinical%20Cell%20Line%20Development) This section outlines the development and clinical trial progress of the AlloStem™ Clinical Cell Line across various indications, including Type I Diabetes and Chronic Lower Back Pain - The AlloStem™ Clinical Cell Line (CELZ-200) was developed in **October 2022**, intended for use across multiple programs including ImmCelz™ immunotherapy, OvaStem™ for Premature Ovarian Failure, Type I Diabetes (CELZ-201 CREATE-1), and AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT)[77](index=77&type=chunk) - The FDA cleared the Type I Diabetes (CELZ-201 CREATE-1) IND application in **November 2022**, allowing a Phase I/II clinical trial to begin patient recruitment in **September 2023**[78](index=78&type=chunk) - In **September 2023**, FDA clearance was received for a Phase I/II clinical trial of AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT), with patient recruitment and dosing initiated between **November 2023** and **July 2024**[83](index=83&type=chunk)[84](index=84&type=chunk)[90](index=90&type=chunk) - Initial data from the CELZ-201 ADAPT clinical trial's **first cohort (10 participants)** in **January 2025** showed no dose-limiting toxicities or serious adverse events, with preliminary efficacy signals for back pain relief. The Data Safety Monitoring Board (DSMB) recommended proceeding to the next cohort, and the **second cohort of 10 patients** was dosed in **Q2 2025**[91](index=91&type=chunk) - In **March 2024**, FDA authorization was secured for an expanded access therapy using CELZ-201 to manage abnormal glucose tolerance and prevent Type I Diabetes in high-risk individuals[85](index=85&type=chunk) [StemSpine® Pilot Study](index=11&type=section&id=StemSpine%C2%AE%20Pilot%20Study) This section reports on the positive three-year follow-up data from the StemSpine® pilot study for chronic lower back pain treatment - Positive **three-year follow-up data** for the StemSpine® pilot study was reported in **February 2023**, demonstrating continued efficacy for treating chronic lower back pain without serious adverse effects[79](index=79&type=chunk) [Type 2 Diabetes Treatment (CELZ-001)](index=11&type=section&id=Type%202%20Diabetes%20Treatment%20(CELZ-001)) This section presents positive one-year follow-up data for CELZ-001 in Type 2 Diabetes patients, highlighting significant insulin requirement reduction - Positive **one-year follow-up data** for CELZ-001 in Type 2 Diabetes patients was reported in **April 2023**, showing significant efficacy with **93% of treated patients** achieving at least a **50% reduction** in insulin requirement, with no safety concerns[82](index=82&type=chunk) [Results of Operations – For the Three-month Periods Ended June 30, 2025, and 2024](index=12&type=section&id=Results%20of%20Operations%20%E2%80%93%20For%20the%20Three-month%20Periods%20Ended%20June%2030,%202025,%20and%202024) This section analyzes the company's financial performance, including revenues, expenses, and net loss, for the three-month periods ended June 30, 2025, and 2024 Financial Performance (Three Months Ended June 30) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :--------------------------------- | :--- | :--- | :--------- | :--------- | | Gross Revenue | $ - | $ 8,000 | $ (8,000) | -100% | | Cost of Goods Sold | $ - | $ 3,200 | $ (3,200) | -100% | | Gross Profit/(Loss) | $ - | $ 4,800 | $ (4,800) | -100% | | Selling, General and Administrative Expenses | $ 731,517 | $ 676,086 | $ 55,431 | 8% | | Research and Development Expenses | $ 501,261 | $ 924,749 | $ (423,488) | -46% | | Operating Loss | $ (1,263,520) | $ (1,625,306) | $ 361,786 | -22% | | Other Income | $ 30,217 | $ 67,578 | $ (37,361) | -55% | | Net Loss | $ (1,233,303) | $ (1,557,728) | $ 324,425 | -21% | - The decrease in R&D expenses by **$423,488 (46%)** was primarily due to the timing of efforts with industry partners[99](index=99&type=chunk) - The increase in SG&A expenses by **$55,431 (8%)** was mainly driven by higher marketing expenses (**$38,362**) and public company expenses (**$21,454**)[97](index=97&type=chunk) [Results of Operations – For the Six-month Periods Ended June 30, 2025, and 2024](index=12&type=section&id=Results%20of%20Operations%20%E2%80%93%20For%20the%20Six-month%20Periods%20Ended%20June%2030,%202025,%20and%202024) This section analyzes the company's financial performance, including revenues, expenses, and net loss, for the six-month periods ended June 30, 2025, and 2024 Financial Performance (Six Months Ended June 30) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :--------------------------------- | :----------- | :----------- | :--------- | :--------- | | Gross Revenue | $ 3,000 | $ 8,000 | $ (5,000) | -62.5% | | Cost of Goods Sold | $ 1,200 | $ 3,200 | $ (2,000) | -62.5% | | Gross Profit/(Loss) | $ 1,800 | $ 4,800 | $ (3,000) | -62.5% | | Selling, General and Administrative Expenses | $ 1,619,914 | $ 1,347,570 | $ 272,344 | 20% | | Research and Development Expenses | $ 1,244,565 | $ 1,347,141 | $ (102,576) | -8% | | Operating Loss | $ (2,923,998) | $ (2,748,453) | $ (175,545) | 6% | | Other Income | $ 52,598 | $ 149,181 | $ (96,583) | -65% | | Net Loss | $ (2,871,400) | $ (2,599,272) | $ (272,128) | 10% | - The **20% increase** in SG&A expenses was primarily due to a **$169,213 increase** in marketing expenses, a **$50,512 general liability contract renewal**, and a **$37,243 increase** in legal expenses[105](index=105&type=chunk) - The **8% decrease** in R&D expenses was due to a **$466,520 reduction** in general R&D and a **$149,729 reduction** in Type I Diabetes clinical trial expenses, partially offset by a **$280,333 increase** in the AlloStemSpine® Chronic Lower Back Pain trial[107](index=107&type=chunk) [Liquidity and Capital Resources](index=13&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations, detailing its cash position and working capital Liquidity Position | Metric | June 30, 2025 | December 31, 2024 | | :-------------------- | :-------------- | :------------------ | | Available Cash & US Treasuries | $6,544,120 | $5,940,402 | | Positive Working Capital | $6,355,063 | $5,807,659 | [Cash Flows](index=13&type=section&id=Cash%20Flows) This section provides an analysis of the company's cash generation and usage from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 Cash Flow Summary (Six Months Ended June 30) | Cash Flow Activity | 2025 | 2024 | | :-------------------------------- | :----------- | :----------- | | Net cash used in operating activities | $ (2,750,282) | $ (2,366,168) | | Net cash received from investing activities | $ - | $ 6,520,191 | | Net cash from financing activities | $ 3,354,000 | $ (149,414) | - Net cash used in operating activities increased by **$384,114 (16%)** primarily due to increased R&D investments and corporate marketing[111](index=111&type=chunk) - Financing activities provided **$3,354,000** in 2025, mainly from warrant exercises, a significant shift from **$149,414** used in 2024 for treasury stock purchases[113](index=113&type=chunk) [Critical Accounting Policies and Estimates](index=13&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section discusses the significant accounting policies and estimates that require management's judgment and can materially affect the financial statements - The preparation of financial statements requires management to make assumptions and estimates about future events and apply judgments that affect reported amounts. These are regularly reviewed, but actual results may differ materially[114](index=114&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=13&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Creative Medical Technology Holdings, Inc. has elected not to provide the disclosures typically required for quantitative and qualitative information about market risk - The company, as a smaller reporting company, has elected not to provide quantitative and qualitative disclosures about market risk[115](index=115&type=chunk) [Item 4. Controls and Procedures](index=13&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures and reports on any changes in internal control over financial reporting during the period [Evaluation of disclosure controls and procedures](index=13&type=section&id=Evaluation%20of%20disclosure%20controls%20and%20procedures) This section confirms management's assessment of the effectiveness of the company's disclosure controls and procedures as of June 30, 2025 - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, ensuring timely and accurate reporting of required information[116](index=116&type=chunk)[118](index=118&type=chunk) [Changes in internal control over financial reporting](index=14&type=section&id=Changes%20in%20internal%20control%20over%20financial%20reporting) This section reports on any material changes in the company's internal control over financial reporting during the period - There were no changes in internal control over financial reporting during the period covered by this report that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[119](index=119&type=chunk) PART II – OTHER INFORMATION This section provides additional information including legal proceedings, equity sales, and a list of exhibits [Item 1. Legal Proceedings](index=14&type=section&id=Item%201.%20Legal%20Proceedings) This section addresses the company's involvement in legal proceedings, noting that while lawsuits may arise in the ordinary course of business, litigation outcomes are inherently uncertain and could potentially harm the business - The company may become involved in various lawsuits and legal proceedings in the ordinary course of business, with inherent uncertainties that could adversely affect the business[121](index=121&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=14&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds,%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section reports on the company's share repurchase program, indicating no share repurchases occurred during the three months ended June 30, 2025 - The company's Board of Directors authorized a share repurchase program for up to **$2 million** of common stock on **June 12, 2023**. No share repurchases were made during the three months ended June 30, 2025[122](index=122&type=chunk) [Item 6. Exhibits](index=14&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including corporate governance documents, certifications, and XBRL-related files - The exhibits include Articles of Incorporation, Bylaws, Rule 13a-14(a)/15d-14a(a) Certifications of Principal Executive and Financial Officers, Section 1350 Certifications, and Inline XBRL documents[123](index=123&type=chunk)

Group 1 - Creative Medical Technology Holdings, Inc. has received a Notice of Allowance for a U.S. patent related to the treatment of Type 1 Diabetes, which will be effective until at least 2040 [1][4] - The patent supports a cell-based immunotherapy approach using the ImmCelz product, which involves supercharged T regulatory cells derived from patients with Type 1 Diabetes [2][5] - Type 1 Diabetes is characterized by the immune system attacking insulin-producing beta cells in the pancreas, leading to insulin deficiency [3] Group 2 - The CEO of Creative Medical emphasizes that the use of ImmCelz represents regenerative immunotherapy and highlights the ongoing CREATE-1 clinical trial focused on Type 1 Diabetes [4] - The ImmCelz platform reprograms a patient's immune cells with optimized cell-free factors, enhancing their regenerative properties for potential treatment of various conditions [5][6] - Creative Medical is a clinical-stage biotechnology company specializing in regenerative medicine solutions across multiple indications, including pain management and neurology [6]

Core Insights - Creative Medical Technology Holdings, Inc. has received a Notice of Allowance for a U.S. patent related to treating heart failure and post-infarct pathological remodeling using its ImmCelz product, with the patent expected to be effective until at least 2040 [1][2]. Group 1: Patent and Product Details - The patent covers treatment for patients at risk of or already experiencing heart failure, utilizing the proprietary ImmCelz product [2]. - The total addressable market for heart failure treatment in the U.S. exceeds five million patients, with an additional six million patients suffering from chronic chest pain who may benefit from the ImmCelz product [2]. - ImmCelz is administered through an ultra-minimally invasive outpatient procedure [2]. Group 2: Company Strategy and Technology - The CEO of Creative Medical emphasized that the Notice of Allowance enhances the company's intellectual property portfolio and reflects the potential of its cell-based technology for developing therapies across various indications [3]. - The ImmCelz platform involves reprogramming a patient's immune cells outside the body with optimized cell-free factors before re-injecting them, which is believed to enhance their regenerative properties [4]. - Creative Medical is focused on pioneering regenerative medicine solutions across multiple indications, including pain management, neurology, and urology [5].