PHOENIX, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT, for the treatment of degenerative disc disease (DDD), a major cause of chronic lower back pain and disability. This designation positions CELZ-201-DDT among a select ...

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].

[PART I – FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements](index=2&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2025 detail the company's first revenue, widened net loss, and strengthened cash position [Unaudited Condensed Consolidated Balance Sheets](index=2&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets increased to **$8.35 million** due to higher cash, with liabilities decreasing and equity growing Consolidated Balance Sheet Summary | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash | $7,702,867 | $5,940,402 | | Total Current Assets | $7,844,011 | $6,135,303 | | **Total Assets** | **$8,347,274** | **$6,669,143** | | **LIABILITIES & EQUITY** | | | | Total Current Liabilities | $286,387 | $327,644 | | **Total Liabilities** | **$286,387** | **$327,644** | | **Total Stockholders' Equity** | **$8,060,887** | **$6,341,499** | | **Total Liabilities & Equity** | **$8,347,274** | **$6,669,143** | [Unaudited Condensed Consolidated Statements of Operations](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, the company generated its first revenue of **$3,000**, but increased operating expenses led to a widened net loss Statement of Operations Summary (Q1 2025 vs Q1 2024) | Metric | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | Revenues | $3,000 | $ - | | Gross Profit | $1,800 | $ - | | Research and development | $743,304 | $422,392 | | Selling, general and administrative | $888,397 | $671,484 | | Operating loss | $(1,660,478) | $(1,123,147) | | **Net Loss** | **$(1,638,097)** | **$(1,041,544)** | | **Net Loss Per Share** | **$(0.83)** | **$(0.73)** | [Unaudited Condensed Consolidated Statements of Cash Flows](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) In Q1 2025, net cash used in operations was **$1.59 million**, offset by financing activities, leading to a net cash increase and an ending cash balance Cash Flow Summary (Q1 2025 vs Q1 2024) | Cash Flow Activity | For the Three Months Ended March 31, 2025 | For the Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,591,535) | $(896,864) | | Net cash provided by investing activities | $ - | $6,520,191 | | Net cash provided by (used in) financing activities | $3,354,000 | $(82,796) | | **Net Increase in Cash** | **$1,762,465** | **$5,540,531** | | **Ending Cash Balance** | **$7,702,867** | **$9,007,398** | [Unaudited Condensed Consolidated Statement of Stockholders' Equity (Deficit)](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholder'%20Equity%20(Deficit)) Stockholders' equity increased from **$6.34 million** to **$8.06 million** in Q1 2025, driven by warrant exercises and offset by the net loss Changes in Stockholders' Equity (Q1 2025) | Description | Amount | | :--- | :--- | | Equity at Dec 31, 2024 | $6,341,499 | | Proceeds from exercise of warrants | $3,700,000 | | Offering costs | $(336,000) | | Net loss | $(1,638,097) | | **Equity at March 31, 2025** | **$8,060,887** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's accounting policies, business risks, and financial items, including licensing agreements and a warrant exercise inducement - The company is a commercial-stage biotechnology firm focused on immunotherapy, endocrinology, urology, neurology, and orthopedics. Its commercial operations are primarily through the sale of CaverStem® and FemCelz® disposable kits[15](index=15&type=chunk)[17](index=17&type=chunk) - In March 2025, the company entered into warrant exercise inducement letters, resulting in the exercise of 837,104 warrants for approximately **$3.7 million** in gross proceeds. In exchange, new 'Inducement Warrants' will be issued pending shareholder approval[55](index=55&type=chunk)[56](index=56&type=chunk) Licensing Agreements Rollforward (Q1 2025) | Licensing Agreements Rollforward | Assets | Accumulated Amortization | | :--- | :--- | :--- | | Balances at December 31, 2024 | $1,060,000 | $(530,559) | | Amortization | - | $(30,577) | | **Balances at March 31, 2025** | **$1,060,000** | **$(561,136)** | [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) Management discusses the company's progress as a commercial-stage biotech firm, highlighting pipeline advancements, increased net loss, and strong liquidity - The company is advancing multiple clinical programs, including CELZ-201 for Type I Diabetes and AlloStemSpine® for Chronic Lower Back Pain, both of which have received FDA clearance for Phase I/II trials[73](index=73&type=chunk)[78](index=78&type=chunk) - In March 2024, the company received Orphan Drug Designation (ODD) from the FDA for its ImmCelz™ (CELZ-100) platform for the treatment of Brittle Type 1 Diabetes[76](index=76&type=chunk) - The company has initiated a program combining artificial intelligence (AI) with its proprietary iPSC platform to diagnose and treat patients exposed to biological and chemical weapons[83](index=83&type=chunk) Results of Operations Comparison (Q1 2025 vs Q1 2024) | Metric | Q1 2025 | Q1 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Gross Revenue | $3,000 | $0 | N/A | | SG&A Expenses | $888,397 | $671,484 | +32% | | R&D Expenses | $743,304 | $422,392 | +76% | | **Net Loss** | **$(1,638,097)** | **$(1,041,544)** | **+57%** | Liquidity Summary | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and equivalents | $7,702,867 | $5,940,402 | | Working Capital | $7,557,624 | $5,807,659 | [Quantitative and Qualitative Disclosures About Market Risk](index=12&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Creative Medical Technology Holdings has elected not to provide typical market risk disclosures - The company has opted out of providing market risk disclosures as permitted for a smaller reporting company[102](index=102&type=chunk) [Controls and Procedures](index=12&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period[103](index=103&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control[105](index=105&type=chunk) [PART II – OTHER INFORMATION](index=13&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=13&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material lawsuits or legal proceedings at this time, though ordinary course of business matters may arise - The company may be involved in ordinary course of business lawsuits but reports no specific material legal proceedings at this time[108](index=108&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=13&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds,%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section discloses the company's share repurchase activity, including the buyback of 5,000 shares in March 2025 under its **$2 million** program - The Board of Directors authorized a share repurchase program for up to **$2 million** of common stock, which commenced in August 2023[109](index=109&type=chunk) Issuer Purchases of Equity Securities (March 2025) | Period | Total Shares Purchased | Average Price Paid per Share | Approx. Dollar Value Remaining in Plan | | :--- | :--- | :--- | :--- | | March 1 - 31, 2025 | 5,000 | $2.00 | $1,549,084 | [Exhibits](index=13&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, CEO/CFO certifications, and XBRL data files - The report includes standard exhibits such as corporate governance documents (Articles of Incorporation, Bylaws), CEO/CFO certifications (Rule 13a-14(a)/15d-14a(a) and Section 1350), and XBRL data files[112](index=112&type=chunk)

Core Viewpoint - Creative Medical Technology Holdings, Inc. (CELZ) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks rating system is based on changes in earnings estimates, tracking EPS estimates from sell-side analysts through a consensus measure known as the Zacks Consensus Estimate [2]. - The company is projected to earn -$2.03 per share for the fiscal year ending December 2025, reflecting a year-over-year change of 45.3% [9]. - Over the past three months, the Zacks Consensus Estimate for Creative Medical Technology Holdings has increased by 9.4% [9]. Impact of Institutional Investors - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements, largely due to institutional investors who adjust their valuations based on these estimates [5]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, which in turn affects stock prices [5]. Zacks Rank System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of Creative Medical Technology Holdings to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [11].

Group 1 - Creative Medical Technology Holdings, Inc. (CELZ) is currently outperforming its peers in the Medical sector with a year-to-date performance increase of approximately 14.3%, compared to the sector average gain of 5% [4] - CELZ has a Zacks Rank of 2 (Buy), indicating a positive outlook based on earnings estimates and revisions [3] - The Zacks Consensus Estimate for CELZ's full-year earnings has increased by 9.4% over the past quarter, reflecting improving analyst sentiment [4] Group 2 - CELZ is part of the Medical - Biomedical and Genetics industry, which includes 509 stocks and currently ranks 74 in the Zacks Industry Rank [6] - The Medical - Biomedical and Genetics industry has seen an average gain of 6% year-to-date, indicating that CELZ is performing better than the industry average [6] - Another stock in the same industry, 89BIO (ETNB), has also shown strong performance with a year-to-date increase of 17% and a Zacks Rank of 2 (Buy) [5][6]

Core Insights - The U.S. FDA has cleared an expanded dose escalation for Creative Medical Technology Holdings' ongoing Phase 1/2 trial of StemSpine® using AlloStem™ (CELZ-201-DDT), a proprietary allogeneic cell therapy for chronic lower back pain due to degenerative disc disease [1][4] - Interim blinded data shows statistically significant pain reduction and improved mobility among trial participants, reinforcing the therapy's potential efficacy [1][2][8] Trial Details - The study utilizes a minimally invasive ultrasound-guided injection of CELZ-201-DDT in an outpatient setting, with a 4:1 treatment-to-placebo ratio [2] - No dose-limiting toxicities or serious adverse events have been reported in the first half of the trial, indicating a strong safety profile [2][8] - The FDA's authorization allows for expanded dosing, which aims to optimize therapeutic outcomes [2][8] Company Perspective - The President and CEO of Creative Medical Technology Holdings emphasized that the FDA's clearance is a significant step towards maximizing safety and efficacy, potentially accelerating the pathway to a pivotal Phase 3 trial for Biologics License Application submission [4] - The company is committed to advancing regenerative medicine solutions to address critical unmet needs in pain management and tissue regeneration [4][6] Product Information - CELZ-201-DDT is designed to target the underlying pathology of degenerative disc disease, offering a non-surgical approach to reduce pain and enhance tissue health without radiation exposure [5][6] Future Outlook - Enrollment in the trial remains on track, with final data expected to influence future clinical and regulatory strategies [8]

Clinical Trials and Efficacy - The company received FDA clearance to initiate a Phase I/II clinical trial for AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT), enrolling 30 individuals[26]. - The company reported a 93% overall efficacy in treated patients with Type 2 Diabetes using CELZ-001, demonstrating at least a 50% reduction in insulin requirement after one year[25]. - The FDA cleared the company's Type I Diabetes (CELZ-201 CREATE-1) IND application, allowing the start of a Phase I/II clinical trial[20]. - The company achieved a significant milestone by generating human iPSC-derived islet cells that produce human insulin, with potential for clinical translation[28]. - The company reported positive three-year follow-up data for the StemSpine® pilot study, showing continued efficacy for treating chronic lower back pain[21]. - The Data Safety Monitoring Board (DSMB) endorsed the continuation of the CELZ-201 ADAPT clinical trial, confirming the safety profile of CELZ-201[39]. - The first cohort of the CELZ-201 ADAPT clinical trial included 10 participants, with 8 receiving CELZ-201-DDT and 2 receiving placebo, showing no dose-limiting toxicities or serious adverse events[33]. - Preliminary blinded data from the CELZ-201 ADAPT trial suggest potential therapeutic benefits in alleviating chronic back pain associated with degenerative disc disease[39]. - The AlloStemSpine® treatment for chronic lower back pain has received FDA approval for a Phase I/IIa study, with initial data showing no serious adverse events in the first cohort of 10 participants[45]. - The StemSpine® procedure has shown a continued efficacy rate of 87% in treating chronic lower back pain over a three-year follow-up period[57]. - The OvaStem™ technology for treating infertility has demonstrated significant efficacy in a pilot study, resulting in the successful birth of healthy babies[63]. - The CELZ-201 CREATE-1 therapy for Type I Diabetes is currently in a Phase I/IIa FDA study, with a treatment group of 12 and a control group of 6[44]. Intellectual Property and Licensing - The company has a robust intellectual property portfolio with four issued patents and fifty pending applications related to stem cell therapies[68]. - The company acquired U.S. Patent No. 9,598,673 for the use of various stem cells in treating lower back pain, with an initial payment of $100,000 made in cash and stock[75]. - The company has made various payments to CMH totaling $300,000 related to the patent agreement, with the remaining obligations settled through stock issuance[77]. - The company entered a Patent License Agreement with Jadi Cell, LLC, granting access to proprietary processes for expanding master cell banks, with an initial license fee of $250,000 paid in stock[78]. - The company has trademark registrations for CaverStem®, StemSpine®, AlloStemSpine®, and FemCelz®, with pending applications for several other brands[81]. - The company has multiple pending patent applications in immunology, including 15/617,813 for immunotherapy of recurrent spontaneous abortions and 63/340,450 for protection from ovarian failure[71]. - The company intends to comply with all applicable FDA regulations to avoid potential enforcement actions that could impact operations[115]. - The company has established a framework for royalty payments of 5% from gross sales of products derived from its patents, ensuring ongoing revenue from successful commercialization[79]. Regulatory Compliance and FDA Interaction - The FDA regulates the company's stem cell treatments under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, requiring compliance with stringent regulations[86]. - The company’s CaverStem® and FemCelz® procedures are exempt from FDA premarket review under the Same Surgical Procedure Exception, while ImmCelz™ requires standard drug approval[91]. - The FDA has broad regulatory authority over drugs and biologics marketed in the United States, including research, clinical testing, manufacturing, and distribution[93]. - The process for FDA approval of a drug or biologic typically involves multiple phases of clinical trials, including Phase 1, Phase 2, and Phase 3, which can take many years and require significant resources[96][102]. - Approval of a New Drug Application (NDA) or Biologics License Application (BLA) requires demonstrating that the product is safe and effective for its intended use[95]. - The FDA may expedite the review of NDAs and BLAs through programs such as Fast Track, Breakthrough Therapy, and Priority Review, which can significantly shorten the review timeline[105][108]. - The FDA requires that post-marketing clinical trials may be necessary to confirm the effectiveness of a product candidate after approval[97]. - Medical devices are classified into three classes based on risk, with Class III devices subject to the highest regulatory scrutiny and requiring premarket approval[112][113]. - The FDA premarket clearance and approval process for medical devices can take from three months to several years, depending on the type of submission[114]. - Compliance with Current Good Manufacturing Practices (cGMP) is essential for products regulated as drugs, biological products, or devices to ensure quality and safety[116]. - The FDA can impose various enforcement actions for non-compliance, including fines, product seizures, and criminal prosecutions, which could materially adversely affect the company[104][117]. - Non-compliance with FDA regulations can lead to severe enforcement actions, including fines and product recalls, which could materially affect the company[92]. - The FDA regulates the entire lifecycle of drugs and biological products, including research, clinical testing, and manufacturing processes[93]. - The approval process for drugs typically involves multiple phases of clinical trials, with Phase 3 requiring statistically significant evidence of efficacy[100]. - If products are regulated as drugs or biological products, significant resources will be needed for regulatory compliance, and the approval process can be lengthy and unpredictable[102]. - The company must submit an IND to begin clinical trials, and an NDA or BLA for marketing approval, which requires demonstrating safety and efficacy[94]. - Phase 4 clinical trials may be required post-approval to address safety issues identified by the FDA[97]. - Changes to approved applications require submission and approval of new NDAs or BLAs, which can involve extensive clinical data[98]. Financial Performance and Investments - The company secured approximately $1.6 million in net proceeds from a registered direct offering and concurrent private placement of common stock[34]. - Research and development expenses for the year ended December 31, 2024, totaled $2,400,777, an increase from $1,970,639 in 2023, reflecting ongoing clinical trials and product development efforts[124]. - The company sold 418,552 shares of common stock at $4.42 per share, generating net proceeds of approximately $1.6 million from the offering[34]. - The company has ongoing obligations totaling $300,000 related to the patent, with payments made in cash and stock over several years[77]. - The company is competing with larger pharmaceutical and biotechnology firms in the regenerative medicine sector, which is rapidly evolving[82]. - The company has made significant investments in research and development, focusing on innovative therapies and technologies in the regenerative medicine field[84].

Core Points - Creative Medical Technology Holdings, Inc. has entered into agreements for the immediate exercise of existing warrants to purchase up to 837,104 shares of common stock at an exercise price of $4.42 per share, expected to generate approximately $3.7 million in gross proceeds [1][2][3] - Roth Capital Partners is acting as the financial advisor for this transaction, and in exchange for the immediate exercise, the company will issue new unregistered warrants for up to 1,674,208 shares at an exercise price of $3.75 per share, exercisable for five years post shareholder approval [2][3] - The transaction is anticipated to close on or about March 6, 2025, subject to customary closing conditions, with net proceeds intended for working capital and general corporate purposes [3][4] Company Overview - Creative Medical Technology Holdings, Inc. is a biotechnology company focused on advancing novel biological therapeutics in immunotherapy, endocrinology, urology, gynecology, and orthopedics, traded on NASDAQ under the ticker symbol CELZ [6]