CELZ 10-Q
Creative Medical Technology Holdings, Inc. (CELZ)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from __________ to __________
Commission File Number:
(Exact name of Registrant as specified in its charter) |
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(State or other jurisdiction of incorporation or organization) |
| (I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
| (Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading Symbol(s) |
| Name of each exchange on which registered |
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| The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
☒ | Smaller reporting company | ||
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| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes
As of August 7, 2026, there were
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PART I – FINANCIAL INFORMATION |
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Item 1. | Financial Statements |
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| Unaudited Condensed Consolidated Statements of Stockholder’ Equity |
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| Notes to Unaudited Condensed Consolidated Financial Statements |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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| 2 |
| Table of Contents |
CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
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| June 30, 2026 |
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| December 31, 2025 |
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ASSETS |
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CURRENT ASSETS |
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Cash |
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Investments in related entity |
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Note receivable, net of premium |
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Prepaids and other current assets |
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Total Current Assets |
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OTHER ASSETS |
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Other assets |
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Licenses, net of amortization |
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TOTAL ASSETS |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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CURRENT LIABILITIES |
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Accounts payable |
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Advances from related party |
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Total Current Liabilities |
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TOTAL LIABILITIES |
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STOCKHOLDERS' EQUITY |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Treasury stock, at cost, |
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TOTAL STOCKHOLDERS' EQUITY |
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Non-controlling interest |
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TOTAL EQUITY ATTRIBUTABLE TO CMTH |
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
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The accompanying notes are an integral part of these condensed consolidated financial statements
| 3 |
| Table of Contents |
CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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| For the Three Months Ended June 30, 2026 |
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| For the Three Months Ended June 30, 2025 |
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| For the Six Months Ended June 30, 2026 |
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| For the Six Months Ended June 30, 2025 |
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Revenues |
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Cost of revenues |
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Gross profit |
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OPERATING EXPENSES |
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Research and development |
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Selling, general and administrative |
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Amortization of patent costs |
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TOTAL EXPENSES |
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Operating loss |
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OTHER INCOME/(EXPENSE) |
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Interest income |
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Total other income (expense) |
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LOSS BEFORE PROVISION FOR INCOME TAXES |
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Provision for income taxes |
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NET LOSS |
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Net income attributable to non-controlling interest |
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NET LOSS ATTRIBUTABLE TO CMTH |
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NET LOSS PER SHARE - BASIC AND DILUTED |
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WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING - BASIC AND DILUTED |
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The accompanying notes are an integral part of these condensed consolidated financial statements
| 4 |
| Table of Contents |
CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
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| For the Six Months Ended June 30, 2026 |
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| For the Six Months Ended June 30, 2025 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation |
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Amortization of intangible assets |
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Amortization of note receivable premium |
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Changes in assets and liabilities: |
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Inventory |
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Prepaids and other current assets |
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Accounts payable |
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Accrued expenses |
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Net cash used in operating activities |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Issuance of note receivable |
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Investment in related entity |
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Net cash used in investing activities |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Contribution from minority member |
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Purchase of treasury stock |
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Proceeds from exercise of warrants, net of issuance costs |
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Net cash provided by financing activities |
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NET CHANGE IN CASH |
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BEGINNING CASH BALANCE |
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ENDING CASH BALANCE |
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SUPPLEMENTAL CASH FLOW INFORMATION: |
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Cash payments for interest |
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Cash payments for income taxes |
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NON-CASH INVESTING AND FINANCING ACTIVITIES: |
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Offering costs in accounts payable |
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The accompanying notes are an integral part of these condensed consolidated financial statements
| 5 |
| Table of Contents |
CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY
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| Additional |
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| Sub-Total |
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December 31, 2025 |
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Contribution by minority member |
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Proceeds from warrant exercise |
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Offering costs |
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Correction to par value |
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Net loss |
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June 30, 2026 |
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| Interest |
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March 31, 2026 |
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Proceeds from warrant exercise |
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Offering costs |
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Correction to par value |
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Net loss |
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June 30, 2026 |
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| 6 |
| Table of Contents |
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| Additional |
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| Total |
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| Common Stock |
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| Stock |
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December 31, 2024 |
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Proceeds from exercise of warrants |
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Offering costs |
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Purchase of treasury shares |
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Stock-based compensation |
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Net loss |
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June 30, 2025 |
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| $ |
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| Additional |
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| Total |
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| Common Stock |
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| Accumulated |
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| Treasury |
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| Shares |
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| Amount |
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| Capital |
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| Deficit |
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| Stock |
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| Equity |
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March 31, 2025 |
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Net loss |
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June 30, 2025 |
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| $ |
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| $ | ( | ) |
| $ | ( | ) |
| $ |
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The accompanying notes are an integral part of these condensed consolidated financial statements
| 7 |
| Table of Contents |
CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2026
NOTE 1 – ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Organization - Creative Medical Technologies Holdings, Inc. (the “Company”) is a commercial stage biotechnology company dedicated to the advancement of regenerative therapies in the fields of immunotherapy, endocrinology, urology, neurology and orthopedics. The Company was incorporated on December 3, 1998, in the State of Nevada under the name Jolley Marketing, Inc. On May 18, 2016, the Company closed a transaction which was accounted for as a recapitalization, reverse merger, under which Creative Medical Technologies, Inc., a Nevada corporation (“CMT”) became the Company’s wholly owned subsidiary, and Creative Medical Health, Inc. (“CMH”), which was CMT’s sole stockholder prior to the merger, became the Company’s principal stockholder. In connection with this merger, the Company changed its name to Creative Medical Technologies Holdings, Inc. to reflect its current business.
CMT was originally created on December 30, 2015 (“Inception”), as the urological arm of CMH to monetize a patent and related intellectual property related to the treatment of erectile dysfunction (“ED”), which it acquired from CMH in February 2016. Subsequently, the Company has expanded its development and acquisition of intellectual property beyond urology to include therapeutic treatments utilizing “re-programmed” stem cells, and the treatment of neurologic disorders, lower back pain, type I diabetes, and heart, liver, kidney, and other diseases using various types of stem cells through our ImmCelz, Inc., StemSpine, Inc. and AlloCelz LLC subsidiaries. However, neither ImmCelz Inc., StemSpine Inc. nor AlloCelz LLC have commenced commercial activities.
In 2020, through the Company’s ImmCelz Inc. subsidiary, the Company began developing treatments that utilize a patient’s own extracted immune cells that are then “reprogrammed” by culturing them outside the patient’s body with optimized stem cells. The immune cells are then re-injected into the patient from whom they were extracted. The Company believes this process endows the immune cells with regenerative properties that may be suitable for the treatment of multiple indications. In contrast to other stem cell-based approaches, the immune cells are significantly smaller in size than stem cells and are believed to more effectively penetrate areas of the damaged tissues and induce regeneration.
On September 15, 2025, the Company formed Bionance LLC, a Nevada limited liability company (“Bionance”), for the purpose of making investments in the securities of publicly traded companies. The Company is the principal member of Bionance and held an 80% interest and has consolidated the operations since inception. See Note 5 for additional information.
Operating Segments and Related Disclosures
We manage our company as one reportable operating segment, The segment information aligns with how the Company’s Chief Operating Decision Maker (“CODM”) reviews and manages our business. The Company’s CODM is the Company’s Chief Executive Officer. Financial information and annual operating plans and forecasts are prepared and reviewed by the CODM at a consolidated level. The CODM assesses performance for the company and decides how to better allocate resources based on consolidated net income that is reported on the Consolidated Statements of Income. Our objective in making resource allocation decisions is to optimize the consolidated financial results. The accounting policies of our operations segment are the same as those described in the summary of significant accounting policies herein.
Risks and Uncertainties - The Company has a limited operating history and has generated minimal revenues from its operations.
The Company’s business and operations are sensitive to general business and economic conditions in the U.S. and worldwide. These conditions include short-term and long-term interest rates, inflation, fluctuations in debt and equity capital markets and the general condition of the U.S. and world economy. A host of factors beyond the Company’s control could cause fluctuations in these conditions, including the political environment and acts or threats of war or terrorism. Adverse developments in these general business and economic conditions, including through recession, downturn or otherwise, could have a material adverse effect on the Company’s financial condition and the results of its operations.
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The Company has generated minimal sales and has limited marketing and/or distribution capabilities. The Company has limited experience in developing, training, or managing a sales force and will incur substantial additional expenses if it decides to market any of its current and future products and services with an internal sales organization. Developing a marketing and sales force is also time-consuming and could delay the launch of its future products and services. In addition, the Company will compete with many companies that currently have extensive and well-funded marketing and sales operations. The Company’s marketing and sales efforts may be unable to compete successfully against these companies. In addition, the Company has limited capital to devote to sales and marketing.
The Company’s industry is characterized by rapid changes in technology and customer demands. As a result, the Company’s products and services may quickly become obsolete and unmarketable. The Company’s future success will depend on its ability to adapt to technological advances, anticipate customer demands, develop new products and services, and enhance the Company’s current products and services on a timely and cost-effective basis. Further, the Company’s products and services must remain competitive with those of other companies with substantially greater resources. The Company may experience technical or other difficulties that could delay or prevent the development, introduction or marketing of new products and services or enhanced versions of existing products and services. Also, the Company may not be able to adapt new or enhanced products and services to emerging industry standards, and the Company’s new products and services may not be favorably received. In addition, the Company may not have the capital resources to further the development of existing and/or new ones.
We cannot predict how global supply chain activities, or the economy at large may be impacted by prolonged global conflicts or sanctions imposed in response to the wars, or whether future conflicts, if any, may adversely affect our results of operations.
Use of Estimates – The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the balance sheet and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Basis of Presentation – The consolidated financial statements and accompanying notes have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. In the opinion of the Company’s management, the consolidated financial statements include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position for the periods presented. These interim financial statements are condensed and should be read in conjunction with the Company’s latest annual financial statements and that interim disclosures generally do not repeat those in the annual statements.
Non-Controlling Interest – The Company accounts for the non-controlling interest in its subsidiary in accordance with U.S. GAAP topic 805: Business Combinations. The Company has chosen to record the minority interests (“NCI”) in the equity section of the consolidated balance sheets and statements, and on the consolidated statements of operations, the profit or loss attributable to the minority interests will be reported as a separate non-operating line item. The Company measures its NCI’s using the percentage of ownership interest held by the respective NCI’s during the accounting period (for share of income or losses) plus the percentage of ownership of net assets at the beginning of the accounting period. The operations of Bionance were insignificant during the six-months ended June 30, 2026, thus, NCI has not been presented on the consolidated statements of operations.
Concentration Risks – The Federal Deposit Insurance Corporation insures cash deposits in most general bank accounts for up to $
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Cash Equivalents – The Company classifies its highly liquid investments with maturities of three months or less at the date of purchase as cash equivalents. Management determines the appropriate classification of its investments at the time of purchase and reevaluates the designations of each investment as of the balance sheet date for each reporting period. The Company classifies its investments as either short-term or long-term based on each instrument’s underlying contractual maturity date. Investments with maturities of less than 12 months are classified as short-term and those with maturities greater than 12 months are classified as long-term. The cost of investments sold is based upon the specific identification method. Investments consist of short-term U.S. treasuries.
Accounts and Notes Receivable – Accounts and notes receivable are stated at net realizable value. An allowance for credit losses is provided based on prior collection experiences and management’s analysis of specific accounts, as well as current economic conditions and forecasts that affect the collectability of the reported amount. At June 30, 2026, in the opinion of management, no material accounts were considered uncollectible and, accordingly, no allowance was deemed necessary.
Inventories – Inventories are valued on a cost basis. The cost of inventories is determined on a first-in, first-out basis.
Fair Value of Financial Instrument – The Company’s financial instruments consist of cash and cash equivalents, and payables. The carrying amount of cash and cash equivalents and payables approximates fair value because of the short-term nature of these items.
Fair value is an exit price, representing the amount that would be received from the sale of an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. Fair value measurements are required to be disclosed by level within the following fair value hierarchy:
Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2 – Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.
Level 3 – Inputs lack observable market data to corroborate management’s estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
When determining fair value, whenever possible the Company uses observable market data, and relies on unobservable inputs only when observable market data is not available. As of June 30, 2026, and 2025, the Company had no outstanding derivative liabilities.
Intangible Assets – Purchased intangible assets with finite lives are amortized over their respective estimated lives and reviewed for impairment whenever events or other changes in circumstances indicate that the carrying amount may not be recoverable. The impairment testing compares carrying values to fair values and, when appropriate, the carrying value of these assets is reduced to fair value. Impairment charges, if any, are recorded in the period in which the impairment is determined. The costs for intangible assets that are developed internally are expensed as incurred.
Impairment – The Company records impairment losses when indicators of impairment are present and undiscounted cash flows estimated to be generated by those assets are less than the assets’ carrying amount. Furthermore, the Company will make periodic assessments of technology and clinical testing to determine if it plans to continue to pursue the technology and if the license, patent, or other rights have value. To date no impairment has been recorded.
Derivative Liabilities – A derivative is an instrument whose value is “derived” from an underlying instrument or index such as a future, forward, swap, option contract, or other financial instrument with similar characteristics, including certain derivative instruments embedded in other contracts and for hedging activities.
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As a matter of policy, the Company does not invest in separable financial derivatives or engage in hedging transactions.
Revenue – The Company recognizes revenues in accordance with Accounting Standards Codification (“ASC”) 606, “Revenue from contracts with customers”. Revenues are recognized when control of the promised goods or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. Deferred revenue represents amounts which still have yet to be earned.
The Company generates revenue from the sale of disposable stem cell concentration kits. Revenues are recognized when control of the promised goods or services are transferred to the customer, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services, which is generally on delivery to the customer.
Payments received for which the earnings process is not yet complete are deferred. As of June 30, 2026 and December 31, 2025, the Company had no deferred revenue.
Research and Development – Research and development will continue to be a significant function of the Company. Research and development costs are expensed as incurred. Expenses in the accompanying financial statements include certain costs which are directly associated with the Company’s two phase I/II clinical trials, and research and development of the ImmCelzTM, AlloStem™, and IPSCs™ technology platforms. These costs, which consist primarily of monies paid for research assets, outsourced research services, laboratory facility expenses, materials and supplies and compensation costs amounted to $
Stock-Based Compensation – The Company accounts for its stock-based compensation in accordance with Accounting Standards Codification (“ASC”) 718, Compensation - Stock Compensation. The Company accounts for all stock-based compensation using a fair-value method on the grant date and recognizes the fair value of each award as an expense over the requisite vesting period. The Company recognizes stock option forfeitures as they occur as there is insufficient historical data to accurately determine future forfeitures rates.
Basic and Diluted Income (Loss) Per Share – The Company follows Financial Accounting Standards Board (“FASB”) ASC 260 Earnings per Share to account for earnings per share. Basic earnings per share (“EPS”) calculations are determined by dividing net loss by the weighted average number of shares of common stock outstanding during the year. Diluted earnings per share calculations are determined by dividing net income by the weighted average number of common shares and dilutive common share equivalents outstanding. During loss periods when common stock equivalents, if any, are anti-dilutive they are not considered in the computation. During the six-months ended June 30, 2026, the Company had options to purchase
Accounting Pronouncements Not Yet Adopted – The Company has reviewed all recently issued, but not yet adopted, accounting standards in order to determine their effects, if any, on its results of operation, financial position or cash flows. On November 4, 2024, the FASB issued ASU 2024-03, Income Statement — Reporting Comprehensive Income — Expense Disaggregation Disclosures. This ASU provides guidance to public companies regarding footnote disclosures of natural expense components (such as employee compensation, depreciation, and amortization) included within each relevant income statement expense caption. The guidance is effective for public companies for fiscal years beginning after December 15, 2026. We are assessing the effect of this update on our consolidated financial statement disclosures.
NOTE 2 – LICENSING AGREEMENTS
ED Patent – The Company acquired a patent from CMH, a related company on February 2, 2016, in exchange for
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Lower Back Patent – The Company, through its subsidiary StemSpine, LLC, acquired a patent from CMH, a related company, on May 17, 2017, covering the use of various stem cells for the treatment of lower back pain from pursuant to a Patent Purchase Agreement, which was amended in November 2017. As amended, the agreement provides the following:
| · | The Company is required to pay CMH $ |
| · | In the event the Company determines to pursue the technology via use of autologous cells, the Company will pay CMH: |
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| · | In the event the Company determines to pursue the technology via use of allogenic cells, the Company will pay CMH: |
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| · | For a period of five years from the date of the first sale of any product derived from the patent, the Company is required to make royalty payments of |
The Company paid CMH the $
The patent expires on
The Company has elected to amortize the additional $
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The Company has elected to amortize the additional $
The Company has elected to amortize the additional $
ImmCelz™ – On December 28, 2020, ImmCelz, Inc. (“ImmCelz”), a newly formed Nevada corporation and wholly owned subsidiary of the Company, entered into a Patent License Agreement dated December 28, 2020 (the “Agreement”), with Jadi Cell, LLC. (“Jadi”), a company controlled by Dr. Amit Patel, a former director of the Company. The Agreement grants to ImmCelz™ the patent rights under U.S. Patent #9,803,176 B2, “Methods and compositions for the clinical derivation of an allogenic cell and therapeutic uses”. The contract grants ImmCelz™ access to proprietary process of expanding the master cell bank of Jadi Cell LLC, as currently practiced by Licensor, and as documented in standard operating procedures (SOPs) and other written documentation to augment autologous cells.
The terms of the agreement are as follows:
| · | Licensee shall pay Licensor a license fee of $ |
| · | Within thirty (30) days of the end of each calendar quarter during the term of this Agreement, Licensee will pay Licensor five percent (5%) of the Net Income of ImmCelz™. during such calendar quarter (the “Continuing Royalty”) |
| · | in one or a series of related transactions, of all or substantially all of the business or assets of Licensee ImmCelz, Inc. (“Sale of Assets”) will result in a one-time ten-percent allocation to the licensor, the Continuing Royalty will be calculated at five percent (5%) of the Net Income of Licensee in any calendar quarter in which the Net Income in such calendar quarter reflects the receipt of any consideration from such Sale of Assets. |
To date, the Company has not made any payments to Jadi Cell under this agreement, other than the $
The Company has elected to amortize the patent over a ten-year period on a straight-line basis. Amortization expenses of $
The following is a roll forward of the Company’s licensing agreements for the six-months ended June 30, 2026.
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NOTE 3 – STOCK-BASED COMPENSATION
On September 6, 2021, the Company’s Board of Directors, and holders of a majority of the voting power of the Company’s stockholders approved the Company’s 2021 Equity Incentive Plan (the “2021 Plan”) and reserved
During the six-months ended June 30, 2026 and 2025, the fair market value of the options was insignificant to the financial statements.
Since the expected life of the options was greater than the Company’s historical stock information available, the Company determined the expected volatility based on price fluctuations of comparable public companies.
There were no options issued during the six-months ended June 30, 2026 and 2025.
Option activity for the six-months ended June 30, 2026, consists of the following:
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In February 2022, we granted a total of
NOTE 4 – STOCKHOLDERS’ EQUITY
Warrant Exercise Inducement Transactions
March 2025
On March 6, 2025, the Company entered into warrant exercise inducement agreements with holders of existing warrants for the exercise of outstanding warrants to purchase an aggregate of
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Roth Capital Partners, LLC (“Roth”) acted as the Company’s financial advisor in connection with the transaction described above. Pursuant to a financial advisory agreement with Roth, the Company (i) paid
October 2025
On October 29, 2025, the Company entered into warrant exercise inducement agreements with holders of existing warrants for the exercise of outstanding warrants to purchase an aggregate of
Roth acted as the Company’s financial advisor in connection with the transaction described above. Pursuant to a financial advisory agreement with Roth, the Company (i) paid Roth a financial advisory fee equal to
June 2026
On June 30, 2026, the Company entered into warrant exercise inducement agreements with holders of existing warrants for the exercise of outstanding warrants to purchase an aggregate of
Roth acted as the Company’s financial advisor in connection with the transaction described above. Pursuant to a financial advisory agreement with Roth, the Company (i) paid Roth a financial advisory fee equal to
Share Repurchase Program
On June 12, 2023, the Company announced that its Board of Directors has approved a share repurchase program. The program authorizes the Company to repurchase up to $
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The Company did not repurchase any shares under this program during the six-months ended June 30, 2026, the Company repurchased
Warrants
In connection with our March 6, 2025 warrant exercise inducement transaction, we issued warrants to purchase
Assumptions used in calculating the fair value of the warrants issued on March 6, 2025 were as follows:
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In connection with our October 29, 2025 warrant exercise inducement transaction, we issued warrants to purchase
Assumptions used in calculating the fair value of the warrants issued on October 29, 2025 were as follows:
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In connection with our June 30, 2026 warrant exercise inducement transaction, we issued warrants to purchase
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As of June 30, 2026, and 2025, warrants to purchase
Warrant activity, for the six-months ended June 30, 2026 consists of the following:
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NOTE 5 – NOTES RECEIVABLE
Bionance Initiative
The Company is the principal member of Bionance LLC, a Nevada limited liability company (“Bionance”), formed for the purpose of making investments in the securities of publicly traded companies (“Investments”). On October 1, 2025, following the approval of the Company’s Board of Directors, the Company and Timothy Warbington, the Company’s Chief Executive Officer, entered into Bionance’s Operating Agreement, pursuant to which, among other things, the Company and Mr. Warbington committed to make up to $
Note #1
During the year ended December 31, 2025, Bionance purchased a convertible promissory note (the “Note”) issued by a third party (the “Issuer”). The Note has a face principal amount of $
The Note is convertible, at the Company’s option, into shares of the Issuer’s common stock. The conversion price is based on a discount to the Issuer’s trading price, defined as 65% of the lowest traded price during the
The Company amortizes the premium of $
Note #2
In January 2026, the Company purchased a convertible promissory note (the "Note") issued by a third party. The Note has a face principal amount of $
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The Note is convertible, at the Company's option, into shares of the Issuer's common stock. The conversion price is based on a discount to the Issuer's trading price, defined as 75% of the average of the five lowest volume-weighted average prices ("VWAPs") of the Issuer's common stock during the
As additional consideration for the purchase of the Note, the Issuer issued
The Company amortizes the premium of $
NOTE 6 – RELATED PARTY INVESTMENT
In January 2026, the Company advanced $
NOTE 7 – SUBSEQUENT EVENTS
On July 1, 2026, in consideration for the successful warrant exercise inducement transaction, our Compensation Committee of the Board of Directors approved the payment of a bonus to Timothy Warbington, the Company’s Chief Executive Officer, in the amount of $
On July 2, 2026, the holder of a warrant issued on October 29, 2025 to purchase
Management has reviewed subsequent events through the date of the filing of this 10-Q and concluded that no additional reportable subsequent events have occurred.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Management’s Discussion and Analysis of Financial Condition and Results of Operations analyzes the major elements of our balance sheets and statements of operations. This section should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2025, and accompanying notes to these financial statements included in this report. All amounts are in U.S. dollars.
Forward-Looking Statement Notice
This quarterly report on Form 10-Q contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by us with the SEC, press releases or oral statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, those set forth in our most recent annual report referenced below.
This report identifies important factors which could cause our actual results to differ materially from those indicated by the forward-looking statements.
All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date of this report and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.
Overview
We are clinical-stage biotechnology company focused on developing regenerative medicine therapies derived from adult and perinatal stem cell technologies. We employ scalable, cGMP manufacturing that enables efficient, cost effective production as programs advance. Supported by a clinical, intellectual property and technological foundation, we are advancing from proof of concept into clinical development in pursuit of regenerative stem cell therapies across multiple indications, with a pipeline targeting addressable markets in orthopedics, immunotherapy, endocrinology, urology and gynecology. Out platforms and therapies include the following:
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Regenerative medicine refers to approaches that seek to repair, replace or restore damaged cells, tissues and organs rather than solely managing symptoms. These approaches are intended to harness or stimulate the body’s own healing processes. The goal is to regenerate functional tissue, such as rebuilding cartilage in an arthritic joint, improving heart muscle after a heart attack or restoring nerve function after injury, which may allow patients to recover more fully and potentially avoid or delay certain surgical interventions and long term drug therapy.
The Company utilizes three proprietary cell platforms – AlloStem™, ImmCelz™ and iPScelz™ – to pursue multiple therapeutic areas, which we believe broadens our market opportunity while diversifying development risk.
We have two U.S. Food and Drug Administration (FDA) cleared clinical trials in progress:
| · | CELZ 201 DDT (ADAPT trial), OlastrocelTM, for chronic lower back pain due to degenerative disc disease is a randomized Phase 1/2 study with FDA Fast Track designation. |
| · | CELZ 201 (CREATE 1 trial) for new onset Type 1 diabetes, currently in Phase 1/2. |
In addition, we have initiated the CELZ Biodefense Platform, a proprietary, artificial intelligence (AI) driven data and discovery initiative focused on evaluating, modelling and developing potential regenerative countermeasures for conditions associated with toxic environmental exposures, such as military burn pits.
We integrate AI, where applicable, into our drug development activities to analyse biological and clinical datasets, prioritize targets and candidates and support efforts to enhance efficiencies, shorten development timelines and increase the probability of success for our programs.
We operate with a lean, cross functional team and a network of strategic partners to advance our programs, including third-party manufacturers. We seek to allocate capital toward programs that we believe have clearer paths to differentiation, regulatory advancement and commercial or partnering potential.
Our lead clinical asset is CELZ 201 (Olastrocel™), which we are advancing toward Phase 3 development as a potential therapy for chronic lower back pain associated with degenerative disc disease. CELZ 201 also serves as the foundation for additional platform programs that we are currently pursuing.
Our cellular platforms are comprised of the following:
| · | AlloStem™: Our FDA cleared, off the shelf, donor derived perinatal tissue technology used in our regenerative programs. We have manufactured clinical grade cells under current Good Manufacturing Practice (cGMP) and believe AlloStem can be scaled across multiple indications. Our AlloStem line includes a Master Cell Bank and a Drug Master File, which helps de risk scale up and commercialization by supporting product consistency, safeguarding our IP, and streamlining future regulatory submissions for programs built on this platform. |
| · | ImmCelz™: A personalized immunotherapy approach that reprograms a patient’s own immune cells with optimized free cell factors. These supercharged cells are then re-injected into the patient from whom they were extracted. This program is being evaluated for its potential to support regenerative and anti-immunomodulatroy effects. Our ImmCelz line is serving as the platform to develop therapies for heart disease and diabetes. |
| · | iPScelz™: Our induced pluripotent stem cell (iPSC) platform, derived from AlloStem, intended to provide a renewable source for creating replacement cell types across a spectrum of degenerative diseases while evading immune rejection. |
Regenerative Medicine Programs
Based on third party industry analyses, we believe the combined market opportunity for our targeted indications is approximately $10 billion. These analyses indicate potential long term growth driven by new therapies, expanded diagnostic rates and broader patient access. We may refine these estimates by indication as additional data become available.
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Olastrocel (CELZ 201) -
Olastrocel, also referred to as CELZ 201, is the Company’s lead allogeneic cell therapy candidate developed on the AlloStem™ platform.
In December 2025, the World Health Organization approved “Olastrocel” as the International Non Proprietary Name for the active cellular substance in CELZ 201. The INN is the globally standardized scientific name used by regulators, clinicians, researchers, and markets to identify a therapeutic substance across development and commercialization. This designation is a key global milestone, typically granted as a program moves into later regulatory stages and requires a unified international identity.
We are currently evaluating Olastrocel™ in our FDA-cleared ADAPT clinical trial for the treatment of chronic lower back associated with degenerative disc disease. This randomized Phase 1/2 study received FDA Fast Track designation in August 2025.
Previously reported interim blinded data showed improvements in disability and pain and did not identify serious adverse events or treatment related safety signals, as confirmed by an independent Data Safety Monitoring Board. In June 2026, the FDA cleared an expansion of the ADAPT trial to enroll an additional cohort of patients receiving less than 90 mg per day in morphine equivalents in order to further characterize safety and efficacy in individuals with ongoing opioid use.
Our near term priorities for Olastrocel™ include completing enrolment of the expanded ADAPT cohort, generating longer term follow up data, continuing regulatory interactions related to Phase 3 planning and evaluating potential strategic and partnering opportunities as the clinical dataset matures.
CELZ-201 is also being used in pre-clinical studies for managing abnormal glucose tolerance and preventing Type I Diabetes in high-risk individuals. This personalized medicine approach is believed to be a first in medical history.
Ultrasome™
Ultrasome™ is our proprietary cell free regenerative therapy program for osteoarthritis of the knee along with other indications and is derived from the CELZ 201 platform. We have reported pilot stage clinical data for Ultrasome™ that achieved the primary endpoint and demonstrated improvements in mobility and pain reduction without serious adverse events.
We believe Ultrasome™ may represent a regenerative approach for osteoarthritis in a large market where currently available therapies may provide only temporary relief. The Company’s near term priorities for the program include designing and initiating the next stage of clinical development, generating multi-center controlled data and evaluating regional, indication specific or broader strategic partnership opportunities intended to support development and commercial planning while seeking to limit dilutive capital needs.
CELZ Biodefense Platform: Project PHOENIX and Toxic Exposure Atlas™
Our CELZ Biodefense platform includes Project PHOENIX and the Toxic Exposure Atlas. The platform is designed to integrate exposure histories, clinical outcomes, multi omics datasets, cell response information and disease biology into a unified framework intended to support AI driven discovery and identification of potential regenerative countermeasures.
During 2026, the BioDefense Inc. Burn Pit Initiative received regulatory approval to proceed nationally. The program is being implemented through existing strategic alliances, infrastructure and vendor relationships. and is intended to operate without the need for new capital raises. In June 2026, Project PHOENIX advanced into a nationwide virtual data collection phase that is intended to scale to at least 1,000 veterans through a mobile app registry and field capable logistics.
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The Company’s near term priorities for the biodefense platform include completing initial enrollment and data ingestion for the first 1,000 veterans in the burn pit registry, advancing AI based modeling to identify exposure linked molecular signatures and potential regenerative countermeasures using the Company’s stem cell and induced pluripotent stem cell platforms and pursuing government and strategic collaborations intended to expand the potential utility of the Toxic Exposure Atlas across broader military and civilian populations.
Results of Operations – For the Three-month Periods Ended June 30, 2026, and 2025
Gross Revenue. No revenues were generated during the three-month periods ended June 30, 2026 and 2025.
Selling, General and Administrative Expenses. General and administrative expenses for the three-months ended June 30, 2026, totaled $1,080,045, in comparison with $731,517 for the comparable period a year ago. The increase of $348,528, or 48% is primarily due to increases of $206,642 in marketing due to a Company-level marketing campaign, $50,513 due to timing of a general liability payment, $38,244 increased salaries from an additional hire and $32,642 in additional travel expenses.
Amortization Expenses. Amortization expenses for the three-months ended June 30, 2026 totaled $22,918 in comparison with $30,742 for the comparable period a year ago.
Research and Development Expenses. Research and development expenses for the three-months ended June 30, 2026, totaled $459,200 in comparison to $501,261 for the comparable period a year ago. The decrease of $42,061, or 8% was primarily due to a decrease of $114,794 associated with the AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) trial as trial proceeds to the follow-up stage, offset by an $66,733 increase in general research and development associated with investments in our other platforms and programs.
Operating Loss. For the reasons stated above, our operating loss for the three-months ended June 30, 2026, was $1,562,163 in comparison with $1,263,520 for the comparable period a year ago.
Other Income. Other income for the three-months ended June 30, 2026, totaled $50,913 in comparison with $30,217 for the comparable period a year ago. The increased income of $20,696 is primarily due to higher short-term investment balances.
Net Income/Loss. For the reasons stated above, our net loss for the three-months ended June 30, 2026, was $1,511,250 in comparison with a net loss of $1,233,303 for the comparable period a year ago.
Results of Operations – For the Six-month Periods Ended June 30, 2026, and 2025
Gross Revenue. There were $0 and $3,000 revenues generated for the six-month periods ended June 30, 2026 and 2025 respectively.
Cost of Goods Sold. There were $0 and $1,200 cost of goods sold for the six-month periods ended June 30, 2026 and 2025 respectively.
Gross Profit/(Loss). There were $0 and $1,800 in gross profits for the six-month periods ended June 30, 2026 and 2025.
Selling, General and Administrative Expenses. General and administrative expenses for the six-months ended June 30, 2026, totaled $1,968,685, in comparison with $1,619,914 for the comparable period a year ago. The increase of $348,771, or 22% is primarily due to increases of $136,025 in marketing from a nation-wide, company-level marketing campaign, $114,971 in salaries due to an additional staff member and bonus payout timing, $51,000 in legal and accounting due to increased public filing activities, $30,214 in travel, and $26,923 in computer and internet expenses.
Amortization Expenses. Amortization expenses for the six-months ended June 30, 2026 totaled $51,773 in comparison with $61,319 for the comparable period a year ago.
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Research and Development Expenses. Research and development expenses for the six-months ended June 30, 2026, totaled $1,000,858 in comparison to $1,244,565 for the comparable period a year ago. The decrease of $243,707, or 20% was primarily due to a decrease of $163,594 in general research and development, and $89,112 associated with the AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) trial and it moves from subject recruitment/dosing to follow-up.
Operating Loss. For the reasons stated above, our operating loss for the six-months ended June 30, 2026, was $3,021,316 in comparison with $2,923,998 for the comparable period a year ago.
Other Income. Other income for the six-months ended June 30, 2026, totaled $106,349 in comparison with $52,598 for the comparable period a year ago. The increased income of $53,571 is primarily due to higher short-term investment balances.
Net Income/Loss. For the reasons stated above, our net loss for the six-months ended June 30, 2026, was $2,914,967 in comparison with a net loss of $2,871,400 for the comparable period a year ago.
Liquidity and Capital Resources
As of June 30, 2026, we had $8,714,115 of available cash and US Treasuries and positive working capital of approximately $8,320,318. In comparison, as of December 31, 2025, we had $7,208,126 of available cash, certificates of deposit and US Treasuries and positive working capital of $7,114,134.
Cash Flows
Net Cash used in Operating Activities. We used cash in our operating activities due to our losses from operations. Net cash used in operating activities was $2,795,555 for the six-months ended June 30, 2026, in comparison to $2,750,282 for the comparable period a year ago, an increase of $1,459 of 0.05%.
Net Cash used in Investing Activities. We used $175,000 in cash in investing activities during the six-months ended June 30, 2026, in comparison to no cash used for the comparable period a year ago. The increase in cash used in investing activities was related to a $125,000 investment in a related entity and a $50,000 investment in a note receivable.
Net Cash from Financing Activities.
Cash received in financing activities for the six-months ended June 30, 2026 was $4,476,544 in proceeds primarily from the June 30, 2026 warrant inducement transaction, in comparison to $3,354,000 in net cash received for the comparable period a year ago, primarily from the March 2025 warrant inducement transaction.
Critical Accounting Policies and Estimates
Our consolidated financial statements are prepared in accordance with generally accepted accounting principles accepted in the United States. In connection with the preparation of our financial statements, we are required to make assumptions and estimates about future events and apply judgments that affect the reported amounts of assets, liabilities, revenue, expenses, and the related disclosures. We base our assumptions, estimates and judgments on historical experience, current trends, and other factors that management believes to be relevant at the time our consolidated financial statements are prepared. On a regular basis, we review the accounting policies, assumptions, estimates and judgments to ensure that our financial statements are presented fairly and in accordance with GAAP. However, because future events and their effects cannot be determined with certainty, actual results could differ from our assumptions and estimates, and such differences could be material.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As a smaller reporting company, we have elected not to provide the disclosure required by this item.
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Item 4. Controls and Procedures
Evaluation of disclosure controls and procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 15(d)-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and (ii) is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Changes in internal control over financial reporting
There were no changes in our internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. However, litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business.
Item 6. Exhibits
Exhibits |
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| Rule 13a-14(a)/15d-14a(a) Certification of Principal Executive Officer* | |
| Rule 13a-14(a)/15d-14a(a) Certification of Principal Financial Officer* | |
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101.INS |
| Inline XBRL Instance Document |
101.SCH |
| Inline XBRL Taxonomy Extension Schema Document |
101.CAL |
| Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF |
| Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB |
| Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE |
| Inline XBRL Taxonomy Extension Presentation Linkbase Document |
* | Filed herewith. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Creative Medical Technology Holdings, Inc. |
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Date: August 7, 2026 | By | /s/ Timothy Warbington |
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| Timothy Warbington, Chief Executive Officer |
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Date: August 7, 2026 | By | /s/ Donald Dickerson |
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| Donald Dickerson, Chief Financial Officer |
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| (Principal Financial Officer) |
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