UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q 

(Mark One)

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended March 31, 2025

 

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: 000-53500

 

Creative Medical Technology Holdings, Inc.

(Exact name of Registrant as specified in its charter)

 

Nevada

 

87-0622284

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

211 E Osborn Road, Phoenix, AZ

 

85012

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (480) 399-2822

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

CELZ

 

The NASDAQ Stock Market LLC

 

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. Yes ☒ No ☐

 

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). Yes ☒ No ☐

 

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

Non-accelerated Filer

Smaller reporting company

 

 

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 No ☒

 

As of May 9, 2025, there were 2,585,532 shares of the registrant’s common stock outstanding.

 

 

 

    

 

 

Page Number

PART I – FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Financial Statements

 

 

 

 

 

 

 

 

Unaudited Condensed Consolidated Balance Sheets

 

3

 

 

 

 

 

 

 

Unaudited Condensed Consolidated Statements of Operations

 

4

 

 

 

 

 

 

 

Unaudited Condensed Consolidated Statements of Cash Flows

 

5

 

 

 

 

 

 

 

Unaudited Condensed Consolidated Statements of Stockholder’ Equity (Deficit)

 

6

 

 

 

 

 

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

 

7

 

 

 

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

15

 

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

20

 

 

 

 

 

 

Item 4.

Controls and Procedures

 

20

 

 

 

 

 

PART II – OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

21

 

 

 

 

 

 

Item 2.

Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities

 

21

 

 

 

 

 

 

Item 6.

Exhibits

 

22

 

 

 
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CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

 

March 31,

2025

 

 

December 31,

2024

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

 

Cash

 

$7,702,867

 

 

$5,940,402

 

Inventory

 

 

994

 

 

 

2,194

 

Prepaids and other current assets

 

 

140,150

 

 

 

192,707

 

Total Current Assets

 

 

7,844,011

 

 

 

6,135,303

 

 

 

 

 

 

 

 

 

 

OTHER ASSETS

 

 

 

 

 

 

 

 

Other assets

 

 

3,281

 

 

 

3,281

 

Licenses, net of amortization

 

 

499,982

 

 

 

530,559

 

TOTAL ASSETS

 

$8,347,274

 

 

$6,669,143

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

 

 

Accounts payable

 

$272,193

 

 

$273,530

 

Accrued expenses

 

 

-

 

 

 

39,920

 

Advances from related party

 

 

14,194

 

 

 

14,194

 

Total Current Liabilities

 

 

286,387

 

 

 

327,644

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES

 

 

286,387

 

 

 

327,644

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Common stock, $0.001 par value, 25,000,000 shares authorized; 2,585,532 and 1,748,428 issued and 2,580,532 and 1,748,428 outstanding at March 31, 2025 and December 31, 2024, respectively

 

 

2,586

 

 

 

1,749

 

Additional paid-in capital

 

 

74,298,311

 

 

 

70,931,663

 

Accumulated deficit

 

 

(66,230,010)

 

 

(64,591,913)

Treasury stock, at cost, 5,000 and 0 shares as of March 31, 2025 and December 31, 2024, respectively

 

 

(10,000)

 

 

-

 

TOTAL STOCKHOLDERS’ EQUITY

 

 

8,060,887

 

 

 

6,341,499

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

8,347,274

 

 

6,669,143

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 
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CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

 

 For the Three Months Ended March 31, 2025

 

 

 For the Three Months Ended March 31, 2024

 

 

 

 

 

 

 

 

Revenues

 

$3,000

 

 

$-

 

 

 

 

 

 

 

 

 

 

Cost of revenues

 

 

1,200

 

 

 

-

 

 

 

 

 

 

 

 

 

 

Gross profit

 

 

1,800

 

 

 

-

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

Research and development

 

 

743,304

 

 

 

422,392

 

Selling, general and administrative

 

 

888,397

 

 

 

671,484

 

Amortization of patent costs

 

 

30,577

 

 

 

29,271

 

TOTAL EXPENSES

 

 

1,662,278

 

 

 

1,123,147

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

(1,660,478)

 

 

(1,123,147)

 

 

 

 

 

 

 

 

 

OTHER INCOME/(EXPENSE)

 

 

 

 

 

 

 

 

Interest income

 

 

22,381

 

 

 

81,603

 

Total other income (expense)

 

 

22,381

 

 

 

81,603

 

 

 

 

 

 

 

 

 

 

LOSS BEFORE PROVISION FOR INCOME TAXES

 

 

(1,638,097)

 

 

(1,041,544)

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

NET LOSS

 

$(1,638,097)

 

$(1,041,544)

 

 

 

 

 

 

 

 

 

NET LOSS PER SHARE - BASIC AND DILUTED

 

$(0.83)

 

$(0.73)

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING - BASIC AND DILUTED

 

 

1,980,735

 

 

 

1,421,439

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 
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CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

 

 

For the Three Months Ended March 31, 2025

 

 

For the Three Months Ended March 31, 2024

 

 

 

 

 

 

 

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

Net loss

 

$(1,638,097)

 

$(1,041,544)

Adjustments to reconcile net loss to

 

 

 

 

 

 

 

 

       net cash used in operating activities:

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

3,485

 

 

 

9,162

 

Amortization

 

 

30,577

 

 

 

29,271

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Inventory

 

 

1,200

 

 

 

-

 

Prepaids and other current assets

 

 

52,557

 

 

 

86,682

 

Accounts payable

 

 

(1,337)

 

 

19,565

 

Accrued Expenses

 

 

(39,920 )

 

 

-

 

Net cash used in operating activities

 

 

(1,591,535)

 

 

(896,864)

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

Redemptions of investments

 

 

-

 

 

 

6,520,191

 

Net cash provided by investing activities

 

 

-

 

 

 

6,520,191

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Purchase of treasury stock

 

 

(10,000)

 

 

(82,796)

Proceeds from exercise of warrants, net of issuance costs

 

 

3,364,000

 

 

 

-

 

Net cash provided by (used in) financing activities

 

 

3,354,000

 

 

 

(82,796)

 

 

 

 

 

 

 

 

 

NET INCREASE IN CASH

 

 

1,762,465

 

 

 

5,540,531

 

BEGINNING CASH BALANCE

 

 

5,940,402

 

 

 

3,466,867

 

ENDING CASH BALANCE

 

$7,702,867

 

 

$9,007,398

 

SUPPLEMENTAL CASH FLOW INFORMATION:

 

 

 

 

 

 

 

 

Cash payments for interest

 

$-

 

 

$-

 

Cash payments for income taxes

 

$-

 

 

$-

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 
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Table of Contents

 

CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIT)

 

 

 

Common Stock

 

 

Additional Paid-in

 

 

Accumulated

 

 

Treasury

 

 

Total Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 Capital

 

 

Deficit

 

 

Stock

 

 

Equity

 

December 31, 2024

 

 

1,748,428

 

 

$1,749

 

 

$70,931,663

 

 

$(64,591,913)

 

$-

 

 

$6,341,499

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from exercise of warrants

 

 

837,104

 

 

 

837

 

 

 

3,699,163

 

 

 

-

 

 

 

-

 

 

 

3,700,000

 

Offering costs

 

 

-

 

 

 

-

 

 

 

(336,000)

 

 

-

 

 

 

-

 

 

 

(336,000)

Purchase of treasury shares

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(10,000)

 

 

(10,000)

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

3,485

 

 

 

-

 

 

 

-

 

 

 

3,485

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,638,097)

 

 

-

 

 

 

(1,638,097)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

March 31, 2025

 

 

2,585,532

 

 

$2,586

 

 

$

74,298,311

 

 

$(66,230,010)

 

$

(10,000)

 

$8,060,887

 

 

 

 

Common Stock

 

 

Additional Paid-in

 

 

Accumulated

 

 

Treasury

 

 

Total Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Stock

 

 

 Equity

 

December 31, 2023

 

 

1,431,126

 

 

$1,431

 

 

$69,711,749

 

 

$(59,098,432)

 

$(270,952)

 

$10,343,796

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of treasury stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(82,796)

 

 

(82,796)

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

9,162

 

 

 

-

 

 

 

-

 

 

 

9,162

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,041,544)

 

 

-

 

 

 

(1,041,544)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

March 31, 2024

 

 

1,431,126

 

 

$1,431

 

 

$

69,720,911

 

 

$(60,139,976)

 

$

(353,748)

 

$9,228,618

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 
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CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2025

 

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 identifying and translating novel biological therapeutics 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.

 

The Company currently conducts substantially all of its commercial operations through CMT, which markets and sells the Company’s CaverStem® and FemCelz® disposable kits utilized by physicians to perform autologous procedures that treat erectile dysfunction and female sexual dysfunction, respectively.

 

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.

 

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.

 

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.

 

 
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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.

 

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.

 

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.

 

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.

 

 
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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 March 31, 2025 and December 31, 2024, the Company had $0 and $40,000 deferred revenue, respectively.

 

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 March 31, 2025, and December 31, 2024, the Company had no outstanding derivative liabilities.

 

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 three-months ended March 31, 2025 and 2024, the Company had options to purchase 11,183 shares of common stock and warrants to purchase 4,147,478 shares of common stock; however, the effects were anti-dilutive due to the net loss.

 

Inventories – Inventories are valued on a cost basis. The cost of inventories is determined on a first-in, first-out basis.

 

Recent Accounting Pronouncements – 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. Based on that review, the Company believes that none of these pronouncements will have a significant effect on its financial statements.

 

 
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NOTE 2 – LICENSING AGREEMENTS

 

ED Patent – The Company acquired a patent from CMH, a related company on February 2, 2016, in exchange for 43,112 shares of CMTH common stock valued at $100,000. The patent expires in 2025 and the Company has elected to amortize the patent over a ten-year period on a straight-line basis. Amortization expense of $2,493 was recorded for the three-months ended March 31, 2025, and 2024. As of March 31, 2025, the carrying value of the patent was $8,576. The Company expects to amortize $9,972 annually through 2026 related to the patent costs.

 

Multipotent Amniotic Fetal Stem Cells License Agreement - On August 25, 2016, CMT entered into a License Agreement dated August 25, 2016, with a university. This license agreement grants to CMT the exclusive right to all products derived from a patent for use of multipotent amniotic fetal stem cells composition of matter throughout the world during the period ending on the expiration date of the longest-lived patent rights under the patent. The license agreement also permits CMT to grant sublicenses. Under the terms of the license agreement, CMT is required to diligently develop, manufacture, and sell any products licensed under the agreement. CMT paid the University an initial license fee within 30 days of entering into the agreement. CMT is also required to pay annual license maintenance fees on each anniversary date of the agreement, which maintenance fees would be credited toward any earned royalties for any given period. The License Agreement provides for payment of various milestone payments and earned royalties on the net sales of licensed products by CMT or any sub licensee. CMT is also required to reimburse the University for any future costs associated with maintaining the patent. CMT may terminate the license agreement for any reason upon 90 days’ written notice and the University may terminate the agreement in the event CMT fails to meet its obligations set forth therein, unless the breach is cured within 30 days of the notice from the University specifying the breach. CMT is also obligated to indemnify the University against claims arising due to the exercise of the license by CMT or any sub licensee. As of March 31, 2025, no amounts are currently due to the University.

 

The Company estimates that the patent expires in February 2026 and has elected to amortize the patent through the period of expiration on a straight-line basis. Amortization expense of $293 was recorded for the three-months ended March 31, 2025, and 2024. As of March 31, 2025, the carrying value of the patent was $568. The Company expects to amortize the remaining $563 annually through February 2026 related to the patent costs.

 

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 $100,000 within 30 days of demand as an initial payment.

 

·

In the event the Company determines to pursue the technology via use of autologous cells, the Company will pay CMH:

 

 

o

$100,000 upon the signing agreement with a university for the initiation of an IRB clinical trial.

 

o

$200,000, upon completion of the IRB clinical trial.

 

o

$300,000 in the event we commercialize the technology via use of autologous cells by a physician without a clinical trial.

 

 
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·

In the event the Company determines to pursue the technology via use of allogenic cells, the Company will pay CMH:

 

 

o

$100,000 upon filing an IND with the FDA.

 

o

$200,000 upon dosing of the first patient in a Phase 1-2 clinical trial.

 

o

$400,000 upon dosing the first patient in a Phase 3 clinical trial.

 

 

·

Payment may be made in cash or shares of our common at a discount of 30% to the lowest closing price within 20 business days prior to the conversion date.

 

·

In the event the Company’s shares of common stock trade below $0.01 per share for two or more consecutive trading days, the number of any shares issuable as payment doubles.

 

·

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 5% from gross sales of products, and 50% of sale price or ongoing payments from third parties for licenses granted under the patent to third parties.

 

The Company paid CMH the $100,000 obligation of the initial payment due under this agreement, by a $50,000 cash payment and the issuance of 667 shares of common stock on December 12, 2020. On December 31, 2020, following the Company’s announcement with respect to the clinical commercialization of the StemSpine technology, the Company paid CMH $50,000 of the $300,000 obligation due under this agreement through the issuance of 14 shares of common stock. On September 30, 2021, the Company paid CMH an additional $40,000 of the $300,000 obligation due under this agreement through the issuance of 8,466 shares of common stock, and in January 2021 the Company paid CMH an additional $50,000 of the $300,000 obligation due under this agreement through the issuance of 8,929 shares of common stock. The remaining portion of the $300,000 obligation was paid in cash in 2020. In August 2023, the Company paid CMH $100,000 related to the filing of an IND with the FDA per the terms of the agreement. In July and August 2024, the Company paid CMH $200,000 related to the dosing of the first patient in a Phase 1-2 clinical trial.

 

The patent expires on May 19, 2027, and the Company has elected to amortize the patent over a ten-year period on a straight-line basis. Amortization expense of $2,500 was recorded for the three-months ended March 31, 2025, and 2024. As of March 31, 2025, the carrying value of the initial patent license was $22,500. The Company expects to amortize approximately $10,000 annually through 2027 related to the patent costs.

 

The Company has elected to amortize the additional $300,000 associated with the patent over a ten-year period on a straight-line basis. Amortization expense of $11,485 was recorded for the three-months ended March 31, 2025, and 2024. As of March 31, 2025, the carrying value of the patent was $53,009. The Company expects to amortize approximately $46,000 annually through 2026 related to the patent costs.

 

The Company has elected to amortize the additional $100,000 associated with the filing of the IND with the FDA over a four-year period on a straight-line basis. Amortization expense of $2,463 was recorded for the three-months ended March 31, 2025, and $2,490 was recorded for the three-months ended March 31, 2024. As of March 31, 2025, the carrying value of the patent was $85,021 The Company expects to amortize approximately $25,000 annually through 2027 related to the patent costs.

 

The Company has elected to amortize the additional $200,000 associated with the dosing of the first patient over a three-year period on a straight-line basis. Amortization expense of $4,929 was recorded for the three-months ended March 31, 2025 and no amortization expense was recorded for the three-months ended March 31, 2024. As of March 31, 2025, the carrying value of the patent was $190,033. The Company expects to amortize approximately $20,000 annually through 2034 related to the patent costs.

 

 
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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 $250,000 (the “Upfront Royalty”), which can also be paid in CELZ stock at a discount of 25% of the closing price of $0.0037, which is based on the date of this agreement

 

·

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 $250,000 initial license fee, which was paid by the issuance of 18,018 shares of common stock to Jadi Cell in February 2022.

 

The Company has elected to amortize the patent over a ten-year period on a straight-line basis. Amortization expenses of $6,250 were recorded for the three-months ended March 31, 2025, and 2024. As of March 31, 2025, the carrying value of the patent was $143,750. The Company expects to amortize approximately $25,000 annually through 2030 related to the patent costs.

 

The following is a rollforward of the Company’s licensing agreements for the three months ended March 31, 2025.

 

 

 

Assets

 

 

Accumulated

Amortization

 

 

 

 

 

 

 

 

Balances at December 31, 2024

 

$1,060,000

 

 

$(530,559 )

Addition of new assets

 

 

-

 

 

 

-

 

Amortization

 

 

-

 

 

 

(30,577

)

Balances at March 31, 2025

 

$1,060,000

 

 

$

(561,136

)

 

NOTE 3 – RELATED PARTY TRANSACTIONS

 

Series B Preferred Stock Purchase

 

On May 14, 2024, Timothy Warbington, our Chief Executive Officer, purchased one share of our newly designated Series B Preferred Stock for a purchase price of $100.  The Series B Preferred Stock had no voting rights other than the right to 100,000,000 votes on a proposal to approve an amendment to the Company’s Articles of Incorporation increasing the number of authorized shares of the Company’s common provided, however, that the Series B Preferred Stock would be voted in the same proportion as the votes cast by shares of common stock on the Share Increase Proposal. The share of Series B Preferred Stock was automatically redeemed when the Share Increase Proposal was approved.  The Series B Preferred Stock was not convertible into common stock. 

 

NOTE 4 – 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 60,000 shares of common stock for the issuance of awards thereunder. The 2021 Plan provides for the granting to our employees, officers, directors, consultants, and advisors of performance awards payable in shares of common stock, stock options (non-statutory and incentive), restricted stock awards, stock appreciation rights (“SARs”), restricted share units (“RSUs”) and other stock-based awards. The purpose of the 2021 Plan is to secure for the Company and its stockholders the benefits arising from capital stock ownership by eligible participants who are expected to contribute to the Company’s future growth and success. As of March 31, 2025, stock options to purchase 11,183 common shares had been granted under the 2021 Plan.

 

 
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During the three-months ended March 31, 2025 and 2024, 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 three months ended March 31, 2025 and 2024.

 

Option activity for the three-months ended March 31, 2025, consists of the following:

 

 

 

Stock

 Options

 

 

Weighted

Average

Exercise

 Price

 

 

Weighted

Average

 Life

 Remaining

 

Outstanding, December 31, 2024

 

 

11,183

 

 

$83.96

 

 

 

7.11

 

Issued

 

 

-

 

 

 

-

 

 

 

-

 

Exercised

 

 

-

 

 

 

-

 

 

 

-

 

Expired

 

 

-

 

 

 

-

 

 

 

-

 

Outstanding, March 31, 2025

 

 

11,183

 

 

$83.96

 

 

 

6.86

 

Vested, March 31, 2025

 

 

11,183

 

 

$83.96

 

 

 

6.86

 

 

In February 2022, we granted a total of 11,182 options to Timothy Warbington and Donald Dickerson at an exercise price of $16.90. The value of the options was determined to be $145,525 based upon the Black-Scholes method, see variables used below. During the three-month periods ended March 31, 2025 and 2024, the Company recorded $3,485 in stock-based compensation. As of March 31, 2025, all stock-based compensation has been accrued.

 

 

 

Inputs

Used

 

 

 

 

 

Annual dividend yield

 

$-

 

Expected life (years)

 

 

6.5

 

Risk-free interest rate

 

 

0.81%

Expected volatility

 

 

92.95%

Common stock price

 

$16.90

 

  

NOTE 5 – STOCKHOLDERS’ EQUITY

 

Warrants

 

On March 6, 2025, we entered into warrant exercise inducement offer letters (the "Inducement Letters") with the holders (the "Holders") of warrants to purchase an aggregate of 837,104 shares of our Common Stock originally issued on October 23, 2024 (collectively, the "Existing Warrants"), pursuant to which the Holders agreed to exercise the Existing Warrants at their current exercise price of $4.42 per share, in exchange for our agreement to issue the Holders new warrants to purchase an aggregate of 1,674,208 shares of common stock (the "Inducement Warrants"). The Inducement Warrants have an exercise price of $3.75 per share, will not be considered granted and exercisable until we have obtained stockholder approval for the issuance of the shares of Common Stock underlying the Inducement Warrants, and will then be exercisable for a period of five years following the date we obtain such stockholder approval. Upon stockholder approval, the Company is expected to record a deemed dividend of approximately $3.9 million representing the difference between the fair market value of the Existing Warrants and Inducement Warrants on the date of the transaction.

 

 
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The transaction closed on March 6, 2025, resulting in total net proceeds to the Company of approximately $3.7 million after deducting placement agent fees and other costs of the offering. The net proceeds received by the Company will be used for working capital and general corporate purposes.

 

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 Roth a financial advisory fee equal to 8% of the aggregate gross proceeds received from the exercise of the Existing Warrants, (ii) reimbursed Roth $40,000 for its legal expenses and (iii) issued Roth a warrant (the “Advisor Warrant”) to purchase 125,566 shares of common stock (being equal to 5.0% of the aggregate number of shares of common stock issuable upon exercise of the Existing Warrants and the Inducement Warrants). The Advisor Warrant has the same terms as the Inducement Warrants.

 

As of March 31, 2025, and 2024, warrants to purchase 4,147,478 and 2,284,932 shares of common stock were outstanding respectively.

 

Warrant activity, which includes the Inducement Warrants for presentation purposes, for the three months ended March 31, 2025 consists of the following:

 

 

 

Warrants

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Life

Remaining

 

Outstanding, December 31, 2024

 

 

3,184,808

 

 

$20.30

 

 

 

2.95

 

Issuances

 

 

1,799,774

 

 

 

3.75

 

 

 

-

 

Exercises

 

 

(837,104 )

 

 

4.42

 

 

 

-

 

Outstanding, March 31, 2025

 

 

4,147,478

 

 

$16.32

 

 

 

3.37

 

 

Assumptions used in calculating the fair value of the warrants issued in 2025 were as follows:

 

 

 

Range of

Inputs 

Used

 

Annual dividend yield

 

$-

 

Expected life (years)

 

 

5.0

 

Risk-free interest rate

 

 

4.04%

Expected volatility

 

 

166.00%

Common stock price

 

$4.56

 

 

NOTE 6 – SUBSEQUENT EVENTS

 

Subsequent to Mar 31, 2025 the shareholders approved the warrant issuance. 

 

 
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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, 2024, 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.

 

 
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Overview

 

We are a commercial stage biotechnology company dedicated to the advancement of identifying and translating novel biological therapeutics in the fields of immunotherapy, endocrinology, urology, neurology and orthopedics. Our platforms, therapies and products include the following:

celz_10qimg2.jpg

   

Our subsidiary, Creative Medical Technologies, Inc. (“CMT”), was originally created to monetize U.S. Patent No. 8,372,797 and related intellectual property related to the treatment of erectile dysfunction (“ED”), which it acquired in February 2016. Subsequently, we have expanded our 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-1 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., nor AlloCelz LLC have commenced commercial activities.

 

In 2020, through our ImmCelz Inc. subsidiary, we began developing treatments under our ImmCelz™ platform (CELZ-100), that utilize a patient’s own extracted immune cells that are then “reprogrammed/supercharged” by culturing them outside the patient’s body with optimized cell-free factors.  The immune cells are then re-injected into the patient from whom they were extracted. We believe this process endows the immune cells with regenerative properties (or “supercharges” them) providing them with the ability to treat multiple indications.  We have validated this ability through the third-party studies described below that were independently conducted on selected human donor patient cells for accuracy and reproducibility. 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.

 

In June 2022, we signed an agreement with Greenstone Biosciences Inc. (“Greenstone”) for the development of a human induced pluripotent stem cell (iPSC) pipeline for our ImmCelz™ platform. This project was identified as iPScelz™. The efforts by Greenstone are expected to complement and expand our current work on novel therapeutic cell lines. In May 2023, we announced that we had received confirmation that Greenstone had successfully developed a human induced pluripotent stem cell (iPSC). We estimate that the development of this cell line will save the Company two to three years in research and development time along with associated expenses. The final iPScelz™ results in a viral-free cell line which has great potential for differentiation into therapeutic biologics both for the cellular and cell-free programs along with targeted drug discovery. Greenstone’s developments were confirmed by an independent, industry-leading research firm.

 

In October 2022, we announced the development of our AlloStem™ Clinical Cell Line (CELZ-200), a proprietary allogenic cell line which includes a Master Cell Bank and a Drug Master File. We believe we will able to use this cell line for many of our programs, including our ImmCelz immunotherapy platform for multiple diseases, OvaStem for Premature Ovarian Failure, Type I Diabetes (CELZ-201 CREATE-1), AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT), and IPScelz™ inducible pluripotent stem cell program in ongoing development with Greenstone.

 

 
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In November 2022, we announced that the FDA had cleared the Company’s Type I Diabetes (CELZ-201 CREATE-1) Investigational New Drug (IND) application for the treatment of Type 1 Diabetes utilizing our AlloStem™ Clinical Cell Line, which will allow us to begin a Phase I/II clinical trial. The primary objective of the study will be to evaluate CELZ-201 treatment in patients with newly diagnosed Type 1 Diabetes. The trial has also received Institutional Board Review (IRB) approval for the trial to proceed as well as approval of the patient recruitment material. Patient recruitment was initiated in September 2023. 

 

In February 2023, we reported positive three-year follow-up data for its StemSpine® pilot study. The three-year data demonstrates continued efficacy of the StemSpine® procedure for treating chronic lower back pain without any serious adverse effects reported.

 

In March 2023, we reported the following results of independent studies:

 

 

·

ImmCelz™ (CELZ-100) platform required 75% fewer donor patient cells compared to industry standard.

 

·

The purity of the final ImmCelz™ (CELZ-100) product was greater than 95% compared to the industry standard of greater than 80%.

 

·

ImmCelz™ (CELZ-100) demonstrated a greater than 200% reduction in functional suppression of effector T cells, which are a critical concern for patients with autoimmune issues, while still possessing a high number of functional T regulatory cells.

 

·

The ability to verify repeated potency of the final ImmCelz™(CELZ-100) product.

 

We believe these results show that we will be able to substantially reduce production costs, while allowing for the manufacture of the best clinical product for patients with immune disorders, which will enable us to accelerate our clinical applications and encourage potential collaborations with respect to our ImmCelz™ platform.

 

In March 2023, we announced that we had filed an application with the FDA to receive Orphan Drug Designation (“ODD”) for the treatment of Brittle Type 1 Diabetes using its ImmCelz™ (CELZ-100) platform. In March 2024 we received the ODD from the FDA. This designation provides multiple important benefits to support the therapy’s development including tax advantages, user fee exemptions, and the opportunity for market exclusivity following approval.

 

In April 2023, we reported positive one-year follow-up data and significant efficacy using CELZ-001 to treat patients with Type 2 Diabetes. There were no safety concerns related to CELZ-001 at one year follow-up utilizing the same infusion procedure as in the currently U.S. FDA cleared Type I Diabetes (CELZ-201 CREATE-1) clinical trial. There were 30 patients in the study, 15 received CELZ-001 and the rest received optimized medical therapy. At one year, there was an overall efficacy of 93% in the treated patients demonstrating at least a 50% reduction in insulin requirement.

 

In September 2023, we received FDA clearance to initiate a Phase I/II clinical trial of AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) using AlloStem™ (CELZ-201-DDT) for the treatment of lower back pain. The first in country study, which will enroll 30 individuals suffering from chronic lower back pain, is designed to evaluate the safety, efficacy, and tolerability of AlloStem™ (CELZ-201-DDT). The minimally invasive procedure uses ultrasound for the targeted delivery of the cell product, and thus prevents radiation exposure to the patient or the injecting physician. This trial, protected by issued patents, is a huge milestone for the Company and for patients suffering from this debilitating problem and their need for opioids for pain.

 

In October, 2023 we filed for and received approval from an institutional review board (IRB) to proceed with the Phase I/II clinical trial for the treatment of chronic lower back pain with its AlloStemSpine® procedure using AlloStem™ (CELZ-201-DDT ADAPT) cell therapy. The clinical trial is registered on www.clinicaltrials.gov. From November 2023 through July 2024, we:

 

 

·

Selected a clinical research site.

 

·

Vetted and contracted with a Contract Research Organization to assist with trial oversight.

 

·

Established a Data Safety Monitoring Board (DSMB) and received authorization to proceed with the trial.

 

·

Initiated patient recruitment and started dosing study subjects.

 

 
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In March 2024, we secured FDA authorization for an expanded access therapy using CELZ-201, in managing abnormal glucose tolerance and preventing Type I Diabetes in high-risk individuals. The therapy uses CELZ-201 to potentially prevent Type I Diabetes onset and is believed to be a first in medical history. This personalized medicine approach, focuses on a single high-risk patient. CELZ-201 has a multi-target mechanism to address abnormal glucose tolerance, a Type I Diabetes precursor, at the cellular level.

 

In June 2024, we announced that we had successfully generated human induced pluripotent stem cells (iPSCs)-derived islet cells that produce human insulin. We believe this development has the potential for not only clinical translation of the human Islet Cells, but also the stand-alone human insulin which is produced by these cells.

 

In July 2024, we announced the initiation of a program to diagnose and treat patients exposed to biological and chemical weapons by combining artificial intelligence (AI) with our proprietary iPSC”. This iPSC clinically derived line is part of our iPSCelz® program. The program is designed to utilize the predictive capabilities of AI to identify damage to patients exposed to biological or chemical weapons and, based on a clinical diagnosis supported by that assessment, use our validated iPSCelz, ImmCelz™ (CELZ-100) and/or AlloStem™ (CELZ-201-DDT) to develop optimized therapeutic options.  The use of AI strengthens the Company’s research efficiency, precision, and innovation. In drug discovery, AI accelerates the identification of potential targets and optimizes biological screenings, significantly shortening development timelines. This model enables the Company to accelerate development for civilian and military options for biological optimization of on-site and remote therapeutic interventions. Along with Greenstone Biosciences Inc., the Company continues to evaluate other collaborators, partners and business opportunities to accelerate development without taking away from the core clinical programs.

 

In November 2024, we announced the successful completion of an independent interim safety review by the Data Safety Monitoring Board (DSMB) of our CELZ-201 ADAPT clinical trial. The DSMB reviewed safety data from the first five dosed patients concluding that the trial may proceed as planned, underscoring the safety profile of CELZ-201 and supporting the advancement of this innovative therapy. This positive review follows the completion of a rigorous 30-day dose-limiting toxicity (DLT) assessment per patient, an important milestone as CELZ-201 moves closer to potentially transformative therapeutic outcomes for patients.

  

In January 2025, we announced promising initial data from the first cohort of the CELZ-201 ADAPT clinical trial. The first cohort of 10 participants (8 receiving CELZ-201-DDT and 2 receiving placebo) completed the study phase without any dose-limiting toxicities or serious adverse events. Blinded preliminary data suggest encouraging therapeutic potential in alleviating back pain and restoring functionality. Following a comprehensive safety review, the independent Data Safety Monitoring Board (DSMB) recommended the trial proceed to the next cohort as planned

 

Key Milestones Achieved:

 

 

·

Safety Confirmed: CELZ-201-DDT demonstrated an excellent safety profile, with no serious adverse events reported in the first cohort.

 

·

Preliminary Efficacy Signals: Blinded data suggest potential therapeutic benefit in addressing chronic back pain associated with degenerative disc disease.

 

·

DSMB Endorsement: The DSMB approved continuation of the study, validating the safety and integrity of the trial design.

 

We began treating the second cohort in this trial in the first quarter of 2025, with comprehensive data from subsequent cohorts guiding future clinical and regulatory plans.

 

On March 6, 2025, we entered into warrant exercise inducement offer letters (the "Inducement Letters") with the holders (the "Holders") of warrants to purchase an aggregate of 837,104 shares of our Common Stock originally issued on October 23, 2024 (collectively, the "Existing Warrants"), pursuant to which the Holders agreed to exercise the Existing Warrants at their current exercise price of $4.42 per share, in exchange for our agreement to issue the Holders new warrants to purchase an aggregate of 1,674,208 shares of common stock (the "Inducement Warrants"). The Inducement Warrants have an exercise price of $3.75 per share, will not be considered granted and exercisable until we have obtained stockholder approval for the issuance of the shares of Common Stock underlying the Inducement Warrants, and will then be exercisable for a period of five years following the date we obtain such stockholder approval.  The transaction closed on March 6, 2025, resulting in total net proceeds to the Company of approximately $3.7 million after deducting placement agent fees and other costs of the offering. Upon stockholder approval, the Company is expected to record a deemed dividend of approximately $3.9 million representing the difference between the fair market value of the Existing Warrants and Inducement Warrants on the date of the transaction.

 

 
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We were incorporated on December 3, 1998, in the State of Nevada under the name Jolley Marketing, Inc. On May 18, 2016, we completed a reverse merger transaction under which Creative Medical Technologies, Inc. became our wholly owned subsidiary. In connection with this merger, we changed our name to Creative Medical Technologies Holdings, Inc. to reflect our current business.

 

Our principal executive offices are located at 211 E Osborn Road, Phoenix, AZ 85012.

 

Results of Operations – For the Three-months Periods Ended March 31, 2025, and 2024

 

Gross Revenue. There was $3,000 in revenue generated for the three-months ended March 31, 2025 in comparison with no in revenues for the comparable period a year ago.

 

Cost of Goods Sold. There was $1,200 in cost of goods sold for the three-months ended March 31, 2025 in comparison to no cost of goods sold for the comparable period a year ago.

 

Gross Profit/(Loss). There was $1,800 in gross profits for the three-months ended March 31, 2025 in comparison to no gross profit for the comparable period a year ago.

 

Selling, General and Administrative Expenses. General and administrative expenses for the three-months ended March 31, 2025, totaled $888,397, in comparison with $671,484 for the comparable period a year ago. The increase of $216,913, or 32% is primarily due to an increase of $130,851 in marketing expenses, timing of a $50,512 general liability insurance payment, and a $19,065 increase in computer and internet expenses.

 

Amortization Expenses. Amortization expenses for the three-months ended March 31, 2025 totaled $30,577 in comparison with $29,271 for the comparable period a year ago.

 

Research and Development Expenses. Research and development expenses for the three-months ended March 31, 2025, totaled $743,304 in comparison to $422,392 for the comparable period a year ago. The increase of $320,912, or 76% was primarily due to increases of $242,240 in general research and $176,629 associated with the CELZ-201 ADAPT Chronic Lower Back Pain clinical trial offset by a decrease of $42,708 on the CELZ-201 CREATE-1 Type II diabetes trial.

 

Operating Loss. For the reasons stated above, our operating loss for the three-months ended March 31, 2025, was $1,660,478 in comparison with $1,123,147 for the comparable period a year ago.

 

Other Income. Other income for the three-months ended March 31, 2025, totaled $22,381 in comparison with $81,603 for the comparable period a year ago. The decreased income of $59,222 is due to lower short-term investment balances.

 

Net Income/Loss. For the reasons stated above, our net loss for the three-months ended March 31, 2025, was $1,638,097 in comparison with a net loss of $1,041,544 for the comparable period a year ago.

 

Liquidity and Capital Resources

 

As of March 31, 2025, we had $7,702,867 of available cash, certificates of deposit and US Treasuries and positive working capital of approximately $7,557,624. In comparison, as of December 31, 2024, we had $5,940,402 of available cash, certificates of deposit and US Treasuries and positive working capital of $5,807,659.

 

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 $1,591,535 for the three-months ended March 31, 2025, in comparison to $896,864 for the comparable period a year ago, an increase of $694,671 or 77%. The increase in cash used in operations was primarily related to an increase in research and development investments and corporate marketing.

 

 
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Net Cash Received From Investing Activities. There was no cash received or spent in investing activities during the three-months ended March 31, 2025, in comparison to $6,520,191 of cash received from net redemptions of certificates of deposit for the comparable period a year ago.

 

Net Cash from Financing Activities.

 

Cash received in financing activities for the three-months ended March 31, 2025 was $3,354,000 in proceeds from the exercise of warrants net of issuance costs, in comparison to $82,796 in cash spent from the purchase of treasury stock for the comparable period a year ago.

 

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.

 

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 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities

 

On June 12, 2023, we announced that our Board of Directors authorized a share repurchase program for the repurchase of up to $2 million of our common stock (the “Repurchase Plan).  Purchases under the Repurchase Plan commenced in August 2023.  The following table provides information about our monthly share repurchases for the three months ended March 31, 2025, which consisted solely of repurchases under the Repurchase Plan.

 

ISSUER PURCHASES OF EQUITY SECURITIES

 

 

 

 

 

 

 

 

 

Period

 

Total Number

of Shares

Purchased

 

 

Average Price

Paid per

Share

 

 

Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs

 

 

Maximum Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs

 

March 1, 2025 – March 31, 2025

 

 

5,000

 

 

$2.00

 

 

 

106,250

 

 

$1,549,084

 

 

 

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Item 6. Exhibits

 

Exhibits

 

 

3.1.1

 

Articles of Incorporation of Creative Medical Technology Holdings, Inc., a Nevada corporation (incorporated by reference to Exhibit 3.1 to the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 17, 2021).

3.1.2

 

Certificate of Amendment to Articles of Incorporation Pursuant to NRS 78.385 and 78.390, as filed with the Secretary of State of the State of Nevada on December 19, 2024 (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 26, 2024).

3.2

 

Bylaws of Creative Medical Technology Holdings, Inc., a Nevada corporation (incorporated by reference to Exhibit 3.2 to the Company’s Form 10 filed with the Securities and Exchange Commission on November 18, 2008).

31.1

 

Rule 13a-14(a)/15d-14a(a) Certification of Principal Executive Officer*

31.2

 

Rule 13a-14(a)/15d-14a(a) Certification of Principal Financial Officer*

32.1

 

Section 1350 Certification of Principal Executive Officer *

32.2

 

Section 1350 Certification of Principal Financial Officer *

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

 

 

 
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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.

 

 

 

 

 

Date: May 9, 2025

By

/s/ Timothy Warbington

 

 

 

Timothy Warbington, Chief Executive Officer

 

 

 

(Principal Executive Officer) 

 

 

 

 

 

Date: May 9, 2025

By

/s/ Donald Dickerson

 

 

 

Donald Dickerson, Chief Financial Officer

 

 

 

(Principal Financial Officer)

 

 

 
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