As Filedfiled with the Securities and Exchange Commission on  November 4, 200823, 2021

Registration No. 333-99515333-259834

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON,Washington, D.C. 20549

_______________________

FORM S-1Amendment No. 1 to

Form S-1/A

REGISTRATION STATEMENT

UNDER THE

SECURITIES ACT OF 1933

_______________________

JOLLEY MARKETING, INC.

(Exact name of Registrant as Specified in Its Charter)

211 E Osborn Road
Phoenix, AZ 85012
(833) 336-7636

374 East 400 South

Suite 3

Springville, UT  84663

(801) 489-9438

(Address, including zip code, and telephone number, including area code,

ofregistrant’s principal executive offices)

Timothy Warbington
Chief Executive Officer

Steven L. White, President

374 East 400 South

Suite 3

Springville, UT  84663

(801) 489-9438

Creative Medical Technology Holdings, Inc.
211 E Osborn Road
Phoenix, Arizona 85012
(833) 336-7636
(Name, address, including zip code, and telephone number,

including area code,of agentsagent for service)

 
Copies of Communications to:

Copies to:

Ronald N. Vance, P.C.

Attorney at Law

1656 Reunion Avenue

Suite 250

South Jordan, UT  84095

(801) 446-8802

(801) 446-8803 (fax)

ron@vancelaw.us

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Approximate date of commencement of proposed sale to thepublic: From time to timeAs soon as practicable after the effective date of this Registration Statement becomes effective.registration statement.

If any of the securities being registered on this formForm are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box.x ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.o ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.o ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.o ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.  (Check one):

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(1)

The maximum offering priceIf an emerging growth company, indicate by check mark if the registrant has been estimated solelyelected not to use the extended transition period for the purpose of determining our registration feecomplying with any new or revised financial accounting standards provided pursuant to Rule 457(o).  The selling stockholders will offerSection 7(a)(2)(B) of the Exchange Act. ☐

CALCULATION OF REGISTRATION FEE

In the event of a stock split, stock dividend, or similar transaction involving our common stock, the number of shares registered shall automatically be increased to sellcover the additional shares of common stock at $0.375 per share until our shares of common stock are quoted onissuable pursuant to Rule 416 under the OTC Bulletin Board, or listed for trading or quoted on any other established public trading market, and thereafter at prices determined at the time of sale by the selling stockholders.Securities Act.

The registrantRegistrant hereby amends this registration statementRegistration Statement on such date or dates as may be necessary to delay its effective date until the registrantRegistrant shall file a further amendment which specifically states that this registration statementRegistration Statement shall thereafterhereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statementRegistration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

2

The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it iswe are not soliciting an offer to buy these securities in any statejurisdiction where the offer or sale is not permitted.

PRELIMINARY PROSPECTUS

SUBJECT TO COMPLETION, DATED NOVEMBER 4, 2008__, 2021

JOLLEY MARKETING, INC.

4,842,615 Units
Each Unit Consisting of

3,113,750 SharesOne Share of Common Stock (par value $0.001)

and

One Warrant to Purchase one Share of Common Stock

This prospectus relates to theis a firm commitment public offering of up4,842,615 units of securities (each, a “Unit”) at a public offering price of $4.13 per unit, each Unit consisting of one share of common stock, $0.001 par value per share, and one warrant to 3,113,750 outstanding sharespurchase one share of common stock, of Jolley Marking,Creative Medical Technology Holdings, Inc., a Nevada corporation, which shares may be sold from time to time by certain of our selling stockholderscorporation. Each warrant is immediately exercisable for their own accounts.  Our common stock does not currently trade in an established public trading market or on any national securities exchange.

The selling stockholders may offer and sell their sharesone share of common stock on a continuous or delayed basis.  The sales may be conducted in the open market or in privately negotiated transactions, and will be made at the fixedan exercise price of $0.0375 per$4.13 share until our shares(or 100% of the price of each share of common stock are quoted onsold in the OTC Bulletin Board, or listed for trading or quoted on any other exchange,offering) and thereafter at fixed prices, prevailing market prices atwill expire five years from the timedate of sale, varying prices or negotiated prices.  Weissuance. The Units will not receive any of the proceeds from the sale ofbe certificated and the shares of common stock and the warrants comprising such Units are immediately separable and will be issued separately in this offering.

Our common stock is quoted for trading on the Pink Market maintained by OTC Markets Group (the “OTC Pink”) under the selling stockholders.symbol “CELZ.” We have applied to have our common stock and the warrants offered pursuant to this prospectus listed on the Nasdaq Capital Market under the symbols “CELZ” and “CELZW,” respectively, which listing is a condition to this offering. No assurance can be given that our application will paybe approved. On November 19, 2021, the expenseslast reported sales price for our common stock as quoted on the OTC Pink was $3.50 per share.

The share and per share information in this prospectus give retroactive effect to the 1-for-500 reverse split of our outstanding common stock effected on November 10, 2021.

__________________________

An investment in our common stock and warrants involves a high degree of risk. Before buying any securities you should carefully read the discussion of the registrationmaterial risks of these shares.

There is no scheduled termination date for this offering.  We are obligated under registration rights agreements with the selling stockholders to keep this offering open for a period of up to one year, unless prior to that date all securities in this offering are sold or can be sold under certain resale safe harbors or are no longer outstanding, or unless a change of control occurs.

Investinginvesting in our common stock involves risks.  You should carefully consider the Risk Factorsand warrants in “Risk Factors” beginning on page 26 of this prospectus.

__________________________

Neither the Securities and Exchange Commission nor any other state securities commission has approved or disapproved of these securities or passed upon the adequacyaccuracy or accuracyadequacy of this prospectus. Any representation to the contrary is a criminal offense.

We have granted the underwriters a 45-day option to purchase up to 726,393 additional shares of common stock and/or warrants to purchase up to 726,393 additional shares of common stock.

The underwriters expect to deliver our shares and warrants to purchasers in the offering on or about           , 2021.

Roth Capital Partners

Prospectus dated [●], 2021.

TABLE OF CONTENTS

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MARKET AND INDUSTRY DATA

The market data and certain other statistical information used throughout this prospectus are based on independent industry publications, governmental publications, reports by market research firms or other independent sources. Some data are also based on our good faith estimates.

BASIS OF PRESENTATION

References herein to the “Company,” “Registrant,” “we,” “us,” “our” and “our company” refer to Creative Medical Technology Holdings, Inc., a Nevada corporation and its subsidiaries.

Certain monetary amounts, percentages and other figures included in this prospectus have been subject to rounding adjustments. Accordingly, figures shown as totals in certain tables or charts and figures expressed as percentages in the text may not total 100% or, as applicable, when aggregated may not be the arithmetic aggregation of the percentages that precede them.

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YOU SHOULD RELY ONLY ON THE INFORMATION CONTAINED IN THIS PROSPECTUS OR IN ANY FREE WRITING PROSPECTUS WE MAY AUTHORIZE TO BE DELIVERED OR MADE AVAILABLE TO YOU. WE HAVE NOT, AND THE UNDERWRITERS HAVE NOT, AUTHORIZED ANYONE TO PROVIDE YOU WITH DIFFERENT INFORMATION. WE ARE NOT MAKING AN OFFER OF THESE SECURITIES IN ANY STATE WHERE THE OFFER IS NOT PERMITTED. YOU SHOULD NOT ASSUME THAT THE INFORMATION PROVIDED IN THIS PROSPECTUS IS ACCURATE AS OF ANY DATE OTHER THAN THE DATE ON THE FRONT OF THIS PROSPECTUS.

No person is authorized in connection with this prospectus to give any information or to make any representations about us, the securities offered hereby or any matter discussed in this prospectus, other than the information and representations contained in this prospectus. If any other information or representation is given or made, such information or representation may not be relied upon as having been authorized by us.

RISK FACTORS

An investment in our securities involves a high degree of risk. You should carefully consider the following risk factors in addition to other information in this prospectus before purchasing our securities. The risks and uncertainties described below are those that we currently deem to be material and that we believe are specific to our company, our industry and our securities. In addition to these risks, our business may be subject to risks currently unknown to us. If any of these or other risks actually occurs, our business may be adversely affected, the trading price of our securities may decline and you may lose all or part of your investment.

Risks Related to our Financial Position and Capital Needs

We have incurred recent losses and our future profitability is uncertain.

We have incurred net losses of approximately $36.3 million and $8.4 million for the years ended December 31, 2020 and December 31, 2019, respectively, and 1,844,000 for the nine months ended September 30, 2021. While our recent losses have predominantly resulted from non-cash charges relating to the change in the fair value of derivative liabilities on our balance sheets, and these derivative liabilities were subsequently substantially extinguished, we expect our operating losses to continue until such time, if ever, that product sales, licensing fees, royalties and other sources generate sufficient revenue to fund our operations. We cannot predict when, if ever, we might achieve profitability and cannot be certain that we will be able to sustain profitability, if achieved.

Even with the proceeds from this offering, we will need additional capital to fund our operations as planned.

 
For the year ended December 31, 2020, our operations used approximately $435,000 in cash, and for the nine months ended September 30, 2021, our operations used approximately $1,054,000 in cash. Cash used in operations consisted primarily of cash on hand and cash raised through private placements of our securities. At September 30, 2021, we had a cash balance of approximately $2,337,930 and current liabilities exceeded current assets by $363,345. Although we expect to raise additional funds from the offering, we will need additional capital to maintain our operations, continue our research and development programs, conduct clinical trials, seek regulatory approvals and manufacture and market our products. We will seek such additional funds through public or private equity or debt financings and other sources. We cannot be certain that adequate additional funding will be available to us on acceptable terms, if at all. If we cannot raise the additional funds required for our anticipated operations, we may be required to reduce the scope of or eliminate our research and development programs, delay our clinical trials and the ability to seek regulatory approvals, downsize our general and administrative infrastructure, or seek alternative measures to avoid insolvency. If we raise additional funds through future offerings of shares of our common stock or other securities, such offerings would cause dilution of current stockholders’ percentage ownership in the Company, which could be substantial. Future offerings also could have a material and adverse effect on the price of our common stock. 

We have generated minimal revenues from our products. We will not achieve profitability unless we generate increased revenues from our current or proposed products or therapies.

Revenues generated from sales of our CaverStem^® and FemCelz^® kits were only $164,500 and $165,500 for the years ended December 31, 2020 and December 31, 2019, respectively, and $20,000 for the nine months ended September 30, 2021.  To sustain our operating costs and generate profits, we will need to significantly increase revenues from our CaverStem^® and FemCelz^® products or from our other products or therapies that have not yet been commercialized.

We expect to continue to incur significant financial losses in the future as we seek regulatory approval for ourImmCelz^TM immunotherapy platform and conduct clinical trials of our StemSpine® Regenerative Stem Cell Procedure for Treatment of Degenerative Disc Disease.

We have not yet received the necessary regulatory approvals for our ImmCelz^TM immunotherapy platform. In addition, we are recruiting patients for a clinical trial of StemSpine® Regenerative Stem Cell Procedure for Treatment of Degenerative Disc Disease in an effort to demonstrate the efficacy of our procedure to the medical community in order to generate demand for this procedure. We anticipate that our expenses will increase substantially as we:

The report of our independent registered public accounting firm expresses substantial doubt about our ability to continue as a going concern.

Our auditors, Haynie & Company, have indicated in their report on our consolidated financial statements for the fiscal year ended December 31, 2020, that conditions exist that raise substantial doubt about our ability to continue as a going concern due to our recurring losses from operations and significant accumulated deficit. In addition, we continue to experience negative cash flows from operations. Notwithstanding the funds we expect to raise in this offering, our auditors may again provide a “going concern” opinion with respect to our future audited financial statements. A going concern opinion could impair our ability to finance our operations through the sale of equity. Our ability to continue as a going concern will depend upon the availability of equity financing which represents the primary source of cash flows that will permit us to meet our financial obligations as they come due and continue our research and development efforts.

Risks Related to Product Development, Regulatory Approval and Commercialization

Our product candidates’ commercial viability remain subject to current and future preclinical studies, clinical trials, regulatory approvals, and the risks generally inherent in the development of biopharmaceutical products. If we are unable to successfully advance or develop our product candidates, our business will be materially harmed.

In the near-term, failure to successfully advance the development of our proposed products may have a material adverse effect on us. To date, other than limited sales generated from our CaverStem^® and FemCelz^® products, we have not successfully developed or commercially marketed, distributed, or sold any product candidate. The success of our business may depend upon our ability to successfully advance the development of our current and future product candidates through preclinical studies and clinical trials, where applicable, have the product candidates approved for sale by the FDA or regulatory authorities in other countries, and ultimately have the product candidates successfully commercialized by us or a commercial partner. We cannot assure you that the results of our ongoing preclinical studies or clinical trials will support or justify the continued development of our product candidates, or that we will receive the necessary approvals from the FDA, or similar regulatory authorities in other countries, to advance the development of our product candidates.

We may not be successful in our commercialization efforts for our proposed products and therapies, which may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

To the extent we possess or obtain the necessary regulatory approval for our proposed products and therapies, we still may not be successful in our commercialization efforts or in gaining sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. Market acceptance will require us to build and maintain strong relationships with healthcare professionals that treat the indications our therapies are intended to address. A failure to build or maintain these important relationships with these healthcare professionals and treatment centers could result in lower market acceptance. Our efforts to educate physicians, patients, third-party payors and others in the medical community on the benefits of our products and therapies may require significant resources and may never be successful. The degree of market acceptance of our products and therapies will depend on a number of factors, including:

The results of our clinical trials may not support our product claims or may result in the discovery of adverse side effects.

Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product claims or that any regulatory authority whose approval we will require in order to market and sell our products in any territory will agree with our conclusions regarding them. Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that clinical trials will replicate the results of prior trials and pre-clinical studies. The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses, which could cause us to abandon a product and may delay development of others. Any delay or termination of our clinical trials will delay the filing of our regulatory submissions and, ultimately, our ability to commercialize our product candidates and generate revenues. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.

We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals.

We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including FDA approval. Our CaverStem^®, FemCelz^® and StemSpine®products are exempt from the FDA premarket review and approval process as these autologous therapies involve treating the patient with his or her own cells. However, we will require FDA approval of ImmCelz^TM for the treatment of stroke and other indications. We have only limited experience in filing the applications necessary to gain regulatory approvals and have relied, and expect to continue to rely, in part, on consultants and third-party contract research organizations, or CROs, with expertise in this area to assist us in this process. Securing FDA approval requires the submission of extensive non-clinical and clinical data and supporting information to the FDA for each therapeutic indication to establish a product candidate’s safety and efficacy for each indication. If third parties upon whom we rely fail to perform satisfactorily, or do not adequately fulfill their obligations under the terms of our agreements with them, our efforts to secure regulatory approval of our product candidates may be delayed or prove unsuccessful.

Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

Clinical trials are expensive and complex, can take many years and have uncertain outcomes. We cannot predict whether we will encounter problems with any of our completed, ongoing or planned clinical trials that will cause us or regulatory authorities to delay or suspend clinical trials, or delay the analysis of data from completed or ongoing clinical trials. We estimate that clinical trials of ImmCelz^TM for the treatment of stroke will continue for several years, but they may take significantly longer to complete. Failure can occur at any stage of the testing and we may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent commercialization of our current or future therapeutic candidates, including but not limited to:

A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier clinical trials. We do not know whether any clinical trials we conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market ImmCelz^TM.

Our autologous products are currently not eligible for reimbursement from public or private insurers.

Currently, our CaverStem^® and FemCelz^® products and related medical procedures are paid for by patients and not eligible for reimbursement from public or private insurers. As a general rule, reimbursement is available only for products and therapies that have been approved of by the FDA. Our CaverStem^® and FemCelz^® products were exempt from the FDA premarket review and approval process as these autologous therapies involve treating the patient with his or her own cells. While we believe that the requirement that patients directly pay the cost for our CaverStem^® and FemCelz^® products and procedures make these procedures more attractive to doctors, these treatments are only available to patients that can afford to pay for them. Our success and extent of our growth will depend in part on the extent to which reimbursement for the costs of our products and related treatments will be available from third party payers, such as public and private insurers and health systems.

The pharmaceutical business is subject to increasing government regulation and reform, including with respect to price controls, reimbursement and access to therapies, which could adversely affect our future revenues and profitability.

Our existing and proposed products may not be considered cost-effective, and third-party or government reimbursement might not be available or sufficient. Globally, governmental and other third-party payors are becoming increasingly aggressive in attempting to contain health care costs by strictly controlling, directly or indirectly, pricing and reimbursement and, in some cases, limiting or denying coverage altogether on the basis of a variety of justifications, and we expect pressures on pricing and reimbursement from both governments and private payors inside and outside the U.S. to continue.

Our existing and proposed products are and will be subject to substantial pricing, reimbursement, and access pressures from state Medicaid programs, private insurance programs and pharmacy benefit managers, and the implementation of U.S. health care reform legislation that is increasing these pricing pressures. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, instituted comprehensive health care reform, and includes provisions that, among other things, reduce and/or limit Medicare reimbursement, and impose new and/or increased taxes. The future of the Affordable Care Act and its constituent parts are uncertain at this time.

The continuing efforts of government and insurance companies, health maintenance organizations, and other payors of health care costs to contain or reduce costs of health care may affect our future revenues and profitability or those of our potential customers, suppliers, and collaborative partners, as well as the availability of capital.

United States federal and state privacy laws, and equivalent laws of other nations, may increase our costs of operation and expose us to civil and criminal sanctions.

Regulation of data processing is evolving, as federal, state, and foreign governments continue to adopt new, or modify existing, laws and regulations addressing data privacy and security, and the collection, processing, storage, transfer, and use of data. These new or proposed laws and regulations are subject to differing interpretations and may be inconsistent among jurisdictions, and guidance on implementation and compliance practices are often updated or otherwise revised, which adds to the complexity of processing personal data. These and other requirements could require us or our collaborators to incur additional costs to achieve compliance, limit our competitiveness, necessitate the acceptance of more onerous obligations in our contracts, restrict our ability to use, store, transfer, and process data, impact our or our collaborators’ ability to process or use data in order to support the provision of our products, affect our or our collaborators’ ability to offer our products in certain locations, or cause regulators to reject, limit or disrupt our clinical trial activities.

We and our collaborators may be subject to federal, state and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state personal information laws, state data breach notification laws, state health information privacy laws and federal and state consumer protection laws and regulations that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH. Depending on the facts and circumstances, we could be subject to civil or criminal penalties if we knowingly use or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not an offerauthorized or permitted by HIPAA.

Later discovery of previously unknown problems could limit our ability to market or sell our products or therapies, and can expose us to product liability claims.

Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with any third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

Discovery of previously unknown problems or risks relating to our product could also subject us to potential liabilities through product liability claims.

If we do not obtain required approvals in other countries in which we aim to market our products, we will be limited in our ability to export or sell the products in those markets.

Our lack of experience in conducting clinical trials in foreign jurisdictions may negatively impact the approval process in those jurisdictions. If we are unable to obtain and maintain required approval from one or more foreign jurisdictions where we would like to sell our products or therapies, we will be unable to market products as intended, our international market opportunity will be limited and our results of operations will be harmed.

We rely in part on third parties for research and clinical trials for our products and therapies.

We rely on contract research organizations (“CROs”), academic institutions, corporate partners, and other third parties to assist us in managing, monitoring, and otherwise carrying out clinical trials and research activities. We rely or will rely heavily on these securities,parties for the execution of our clinical studies and control only certain aspects of their activities. Accordingly, we may have less control over the timing and other aspects of these clinical trials than if we conducted them entirely on our own. Although we rely on these third parties to manage the data from clinical trials, we will be responsible for confirming that each of our clinical trials is conducted in accordance with its general investigational plan and protocol. Our failure, or the failure of third parties on which we rely, to comply with the strict requirements relating to conducting, recording, and reporting the results of clinical trials, or to follow good clinical practices, may delay the regulatory approval process or cause us to fail to obtain regulatory approval for our proposed products and therapies.

We currently have a very limited marketing and sales organization and may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products and therapies, we may not be able to generate sufficient revenues to support our operations.

Our current sales, marketing and distribution capabilities consist of one independent contractor who promotes the sale our CaverStem^® and FemCelz^® products to medical doctors. To generate sufficient revenues to support our operations, we will have to seek collaborators, especially for marketing and sales outside of the United States, or invest significant amounts of financial and management resources to develop internal sales, distribution and marketing capabilities. We may not be able to enter into collaborations or hire consultants or external service providers to assist us in sales, marketing and distribution functions on acceptable financial terms, or at all. In addition, our product revenues and our profitability, if any, may be lower if we rely on third parties for these functions than if we were to market, sell and distribute products that we develop ourselves. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. Even if we determine to perform sales, marketing and distribution functions ourselves, we could face a number of additional related risks, including:

We rely upon third parties for the manufacture of our CaverStem^® and FemCelz^®disposable kits and are dependent on their quality and effectiveness.

We rely upon third parties for the manufacture of our CaverStem^® and FemCelz^® disposable kits. The failure to achieve and maintain high manufacturing standards, or to detect or control anticipated or unanticipated manufacturing errors or the frequent occurrence of such errors, could result in cost overruns, product recalls or withdrawals, patient injury or death, and other problems that could seriously hurt our business.

We may be unable to compete effectively with marketed therapies or drugs targeting similar indications to our products and therapies.

We face competition generally from established pharmaceutical and biotechnology companies, as well as from academic institutions, government agencies and private and public research institutions. Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Small or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Our commercial opportunity will be reduced or eliminated if our competitors develop and commercialize any products that are safer, more effective, have fewer side effects or are less expensive than our products and therapies. These potential competitors may also compete with us in establishing clinical trial sites, and patient enrollment for clinical trials.

Our business and operations would suffer in the event of computer system failures or security breaches.

In the ordinary course of our business, we collect, store and transmit confidential information, including intellectual property, and proprietary business information. Despite the implementation of security measures, our internal computer systems, and those of our contract research organizations, or CROs, and other third parties on which we rely, are vulnerable to damage from computer viruses, unauthorized access, cyberattacks, natural disasters, fire, terrorism, war and telecommunication and electrical failures. Cyberattacks are increasing in their frequency, sophistication and intensity. Cyberattacks could include the deployment of harmful malware, denial-of-service attacks, social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information. Significant disruptions of our information technology systems or security breaches could adversely affect our business operations and/or result in the loss, misappropriation, and/or unauthorized access, use or disclosure of, or the prevention of access to, confidential information (including trade secrets or other intellectual property and proprietary business information and personal information), and could result in financial, legal, business and reputational harm to us. If such disruptions were to occur and cause interruptions in our operations, it could result in a material disruption of our product development programs. For example, the loss of clinical trial data from completed, ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Further, the COVID-19 pandemic has resulted in a significant number of our employees and partners working remotely, which increases the risk of a data breach or issues with data and cybersecurity. To the extent that any disruption or security breach results in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of our future product candidates could be delayed.

We are subject to risks arising from the recent global outbreak of the COVID-19 coronavirus.

The recent outbreak of the COVID-19 coronavirus has spread across the globe and is impacting worldwide economic activity. A pandemic, including COVID-19 or other public health epidemic, poses the risk that we or our employees, CROs, suppliers, manufacturers and other partners may be prevented from conducting business activities for an indefinite period of time, including due to the spread of the disease or shutdowns that may be requested or mandated by governmental authorities. During 2020 and 2021, COVID-19 has resulted in significantly reduced revenues from our CaverStem^® and FemCelz^® products, as elective procedures in general have been greatly reduced throughout the United States during the pandemic. In addition, the continued spread of COVID-19 could disrupt our clinical trials, supply chain and the manufacture or shipment of our products, and other related activities, which could have a material adverse effect on our business, financial condition and results of operations. COVID-19 has also had an adverse impact on global economic conditions which could impair our ability to raise capital when needed.

Risks Related to Our Intellectual Property

We may not be able to protect our proprietary rights.

Our commercial success will depend in large part upon our ability to protect our proprietary rights. There is no assurance, for example, that any additional patents will be issued based on our or our pending applications or, if issued, that such patents will not become the subject of a re-examination, will provide us with competitive advantages, will not be challenged by any third parties, or that the patents of others will not prevent the commercialization of products and services incorporating our technology. Furthermore, there can be no guarantee that others will not independently develop similar products and services, duplicate any of our products and services, or design around any patents we obtain.

Our commercial success will also depend upon our ability to avoid infringing patents issued to others. If we were judicially determined to be infringing on any third-party patent, we could be required to pay damages, alter our products, services or processes, obtain licenses, or cease certain activities. If we are required in the future to obtain any licenses from third parties for some of our products and/or services, there can be no guarantee that we would be able to do so on commercially favorable terms, if at all. United States and foreign patent applications are not immediately made public, so we might be surprised by the grant to someone else of a patent on a technology we are actively using.

In addition to patents, we rely on unpatented trade secrets and proprietary technological expertise, and confidentiality agreements with our partners, employees, advisors, vendors, and consultants to protect our trade secrets and proprietary technological expertise. There can be no guarantee that these agreements will not be breached, or that we will have adequate remedies for any breach, or that our unpatented trade secrets and proprietary technological expertise will not otherwise become known or be independently discovered by competitors.

Failure to obtain or maintain patent protection or to protect our trade secrets could have a substantial negative effect on our results of operations and financial condition.

We are susceptible to intellectual property suits that could cause us to incur substantial costs or pay substantial damages or prohibit us from selling our product candidates.

There is a substantial amount of litigation over patent and other intellectual property rights in the biotechnology industry. Whether or not a product infringes a patent involves complex legal and factual considerations, the determination of which is often uncertain. Our competitors or other parties may assert that our product candidates and the methods employed may be covered by patents held by them. If any of our products infringes a valid patent, we could be prevented from manufacturing or selling such product unless we are able to obtain a license or able to redesign the product in such a manner as to avoid infringement. A license may not always be available or may require us to pay substantial royalties. We also may not be successful in any attempt to redesign our product to avoid infringement, nor does a later redesign protect the Company from prior infringement.

We may need to initiate lawsuits to protect or enforce our intellectual property rights, which could be expensive and, if we lose, could cause us to lose some of our intellectual property rights, which would harm our ability to compete in the market.

In order to protect or enforce our intellectual property rights, we may need to initiate patent, trademark and related litigation against third parties, such as infringement suits or requests for injunctive relief. Our ability to establish and maintain a competitive position may be achieved in part by prosecuting claims against others who we believe to be infringing its rights. Any lawsuits or administrative proceedings in patent offices that we initiate or that are initiated against us could be expensive, take significant time and divert our management’s attention from other business concerns and the outcome of litigation to enforce our intellectual property rights in patents, trade secrets or trademarks is highly unpredictable. Litigation also puts our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, or adversely affect our ability to distribute any products that are subject to such litigation. In addition, we may provoke third parties to assert claims against us. We may not prevail in any lawsuits or administrative proceedings that we initiate, and the damages or other remedies awarded, including attorney fees, if any, may not be commercially valuable.

Risks Related to Employee Matters

We are dependent on our executive officers, and we may not be able to pursue our current business strategy effectively if we lose them.

Our success to date has largely depended on the efforts and abilities of Timothy Warbington, our Chief Executive Officer, and Drs. Thomas Ichim and Amit Patel, who were our founders and who currently serve as directors and/or consultants to us. Our ability to manage our operations and meet our business objectives could be adversely affected if, for any reason, such officers do not remain with us.

Our employees, clinical trial investigators, CROs, consultants, vendors and any potential commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards.

We are exposed to the risk of fraud or other misconduct by our employees, clinical trial investigators, CROs, consultants, vendors and any potential commercial partners. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates: (i) U.S. laws and regulations or those of foreign jurisdictions, including those laws that require the reporting of true, complete and accurate information, (ii) manufacturing standards, (iii) federal and state health and data privacy, security, fraud and abuse, government price reporting, transparency reporting requirements, and other healthcare laws and regulations in the United States and abroad or (iv) laws that require the true, complete and accurate reporting of financial information or data. Such misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation. We have adopted a code of conduct applicable to our employees, but it is not solicitingalways possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from government funded healthcare programs, such as Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional integrity reporting and oversight obligations, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

If we fail to comply with the U.S. federal Anti-Kickback Statute and similar state and foreign country laws, we could be subject to criminal and civil penalties and exclusion from federally funded healthcare programs including the Medicare and Medicaid programs and equivalent third country programs, which would have a material adverse effect on our business and results of operations.

A provision of the Social Security Act, commonly referred to as the federal Anti-Kickback Statute, prohibits the knowing and willful offer, payment, solicitation or receipt of any form of remuneration, directly or indirectly, in cash or in kind, to induce or reward the referring, ordering, leasing, purchasing or arranging for, or recommending the ordering, purchasing or leasing of, items or services payable, in whole or in part, by Medicare, Medicaid or any other federal healthcare program. The federal Anti-Kickback Statute is very broad in scope and many of its provisions have not been uniformly or definitively interpreted by existing case law or regulations. In addition, many states have adopted laws similar to the federal Anti-Kickback Statute that apply to activity in those states, and some of these laws are even broader than the federal Anti-Kickback Statute in that their prohibitions may apply to items or services reimbursed under Medicaid and other state programs or, in several states, apply regardless of the source of payment. Violations of the federal Anti-Kickback Statute may result in substantial criminal, civil or administrative penalties, damages, fines and exclusion from participation in federal healthcare programs.

While we believe our operations will be in compliance with the federal Anti-Kickback Statute and similar state laws, we cannot be certain that we will not be subject to investigations or litigation alleging violations of these laws, which could be time-consuming and costly to us and could divert management’s attention from operating our business, which in turn could have a material adverse effect on our business. In addition, if our arrangements were found to violate the federal Anti-Kickback Statute or similar state laws, the consequences of such violations would likely have a material adverse effect on our business, results of operations and financial condition.

Risks Related To Our Common Stock and This Offering

Our management has broad discretion as to the use of the net proceeds from this offering.

We currently intend to use the net proceeds that we receive from this offering to (i) redeem our Bridge Notes in the outstanding amount of $5,146,176, (ii) repurchase our Series A Preferred Stock from our Chief Executive Officer for an offeraggregate purchase price of approximately $195,000, (iii) hire marketing and sales personnel to buysupport sales of our CaverStem^® and FemCelz^® products, (iv) proceed with a clinical study of 100 patients intended to support the safety and efficacy of our StemSpine® Regenerative Stem Cell Procedure for Treatment of Degenerative Disc Disease, (v) conduct a Phase I clinical trial for the treatment of stroke utilizing our ImmCelz^TM technology, (vi) continue to develop other products and therapies, and (vii) fund working capital and general corporate purposes using any remaining amounts. Our management will have broad discretion in the application of the net proceeds, including for any of the purposes described in “Use of Proceeds.” Accordingly, you will have to rely upon the judgment of our management with respect to the use of the proceeds. Our management may spend a portion or all of the net proceeds from this offering in ways that holders of our common stock may not desire or that may not yield a significant return or any return at all. The failure by our management to apply these securities,funds effectively could harm our business. Pending their use, we may also invest the net proceeds from this offering in any state where the offera manner that does not produce income or salethat loses value.

There is not permitted.no assurance that an active trading market for our common stock will be sustained, and there is no market for our warrants.

The public offering price for the securities will be determined by negotiations between us and the representatives of the underwriters and may not be indicative of prices that will prevail in the trading market. Upon closing of this offering, our common stock and warrants will be listed on the Nasdaq Capital Market, however, we cannot ensure that an active public market for our common stock and warrants will develop after this offering, or that if it does develop, it will be sustained. In the absence of an active public trading market:

The market price of our common stock may be highly volatile, and you could lose all or part of your investment.

The trading price of our common stock and warrants is likely to be volatile. This volatility may prevent you from being able to sell your securities at or above the price you paid for your securities. Our stock price and warrant price could be subject to wide fluctuations in response to a variety of factors, which include:

In addition, the stock market in general, and the stock of clinical stage biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.

You will experience immediate and substantial dilution as a result of this offering and may experience additional dilution in the future.

You will incur immediate and substantial dilution as a result of this offering.  After giving effect to the sale by us of 4,842,615 Units in this offering at a public offering price of $4.13 per Unit, after deducting underwriter discounts and commissions and estimated offering expenses payable by us, investors in this offering can expect an immediate dilution of $2.12 per share. For a further description of the dilution that investors in this offering may experience, see “Dilution.”

In the past, we have issued shares of common stock and warrants in private placements of our securities, and we have issued shares of common stock as compensation to our officers and directors. Our issuance of shares of common stock in the future, and the exercise of outstanding warrants or warrants that we may issue in the future, may result in additional dilution to investors in this offering.

If, after being listing on The Nasdaq Capital Market, we are delisted and our shares become subject to the penny stock rules, it would become more difficult to trade our shares.

The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00, other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system. If we do not maintain a listing on Nasdaq and if the price of our common stock is less than $5.00, our common stock will be deemed a penny stock. The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement; (ii) a written agreement to transactions involving penny stocks; and (iii) a signed and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore stockholders may have difficulty selling their shares.

If our securities are listed on Nasdaq, our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a de-listing of our securities.

If after listing we fail to satisfy the continued listing requirements of Nasdaq, such as the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps to de-list our securities. Such a de-listing would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a de-listing, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our securities, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

We will indemnify and hold harmless our officers and directors to the maximum extent permitted by Nevada law.

Our bylaws provide that we will indemnify and hold harmless our officers and directors against claims arising from our activities, to the maximum extent permitted by Nevada law. If we were called upon to perform under our indemnification agreement, then the portion of our assets expended for such purpose would reduce the amount otherwise available for our business.

Substantial future sales of shares of our common stock in the public market could cause our stock price to fall.

Except for 226,948 shares of our common stock held by our affiliates, all of our outstanding shares of common are currently freely trading or eligible for resale without restriction under Rule 144.  In addition, the lock-up agreements which our officers, directors, and principal stockholders entered into with the underwriter expire six months after the date of this prospectus. Upon the expiration of those lock-up agreements, the outstanding shares of common stock covered by them become eligible for resale in the open market (subject to Rule 144 volume limitations applicable to executive officers, directors and 10% or more stockholders), resulting in more shares eligible for sale and potentially causing selling in the market to increase and our stock price to decline. Additional sales of a substantial number of our shares of our common stock in the public market, or the perception that sales could occur, could have a material adverse effect on the price of our common stock.

Because we do not expect to pay dividends for the foreseeable future, investors seeking cash dividends should not purchase shares of common stock.

We have never declared or paid any cash dividends on our common stock. We currently intend to retain future earnings, if any, to finance the expansion of our business. As a result, we do not anticipate paying any cash dividends in the foreseeable future. Our payment of any future dividends will be at the discretion of our Board of Directors after taking into account various factors, including but not limited to our financial condition, operating results, cash needs, growth plans and the terms of any credit agreements that we may be a party to at the time. Accordingly, investors seeking cash dividends should not purchase our shares.

Warrants are speculative in nature.

The warrants offered pursuant to this prospectus do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends, but rather merely represent the right to acquire shares of our commons stock at a fixed price for a limited period of time. Specifically, commencing on the date of issuance, holders of the warrants may exercise their right to acquire the common stock and pay an exercise price of $4.13, prior to five years from the date of issuance, after which date any unexercised warrants will expire and have no further value. Moreover, following this offering, the market value of the warrants is ____________, 2008uncertain and there can be no assurance that the market value of the warrants will equal or exceed their public offering price. There can be no assurance that the market price of the common stock will ever equal or exceed the exercise price of the warrants, and, consequently, whether it will ever be profitable for holders of the warrants to exercise the warrants.

3We are an “emerging growth company” and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, our common stock may be less attractive to investors.

TABLE OF CONTENTS

We are an “emerging growth company” as defined in the Jump-Start Our Business Startups Act, or the JOBS Act, and we take advantage of some of the exemptions from reporting requirements that are applicable to other public companies that are not emerging growth companies, including:

PageWe cannot predict if investors will find our common stock less attractive because we will rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. We currently expect that we will remain an emerging growth company until December 31, 2021.

PROSPECTUS SUMMARY

5Under Section 107(b) of the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

RISK FACTORS

5Risks Associated with Our Reverse Stock Split

The 1-for-500 reverse stock split has caused our stock price to decline relative to its value before the split.

We effected a reverse stock split of our authorized, issued and outstanding common stock on November 10, 2021 at a ratio of 1-for-500 in order to achieve a sufficient increase in our stock price to enable us to qualify for listing on Nasdaq. Following the effectiveness of the reverse stock split, there has been a substantial decrease in our share price, and there is no assurance that the reverse split will not cause a further decline in the value of our outstanding common stock.  

We cannot assure you that we will be able to continue to comply with the minimum bid price requirement of The Nasdaq Capital Market.

There can be no assurance that the market price of our common stock will remain at the level required for continuing compliance with that requirement. It is not uncommon for the market price of a company’s common stock to decline in the period following a reverse stock split. If the market price of our common stock continues to decline following the effectuation of the reverse stock split, the percentage decline may be greater than would occur in the absence of a reverse stock split. In any event, other factors unrelated to the number of shares of our common stock outstanding, such as negative financial or operational results, could adversely affect the market price of our common stock and jeopardize our ability to meet or maintain The Nasdaq Capital Market’s minimum bid price requirement.

The reverse stock split may decrease the liquidity of the shares of our common stock.

The liquidity of the shares of our common stock may be affected adversely by the reverse stock split given the reduced number of shares that are now outstanding following the reverse stock split, especially if the market price of our common stock does not increase as a result of the reverse stock split. In addition, the reverse stock split has increased the number of stockholders who own odd lots (less than 100 shares) of our common stock, creating the potential for such stockholders to experience an increase in the cost of selling their shares and greater difficulty effecting such sales.

Following the reverse stock split, the resulting market price of our common stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.

Although we believe that a higher market price of our common stock may help generate greater or broader investor interest, there can be no assurance that the reverse stock split will result in a share price that will attract new investors, including institutional investors. In addition, there can be no assurance that the market price of our common stock will satisfy the investing requirements of those investors. As a result, the trading liquidity of our common stock may not necessarily improve.

DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS

8

The information contained in this prospectus contains certain forward-looking statements. All statements other than statements of historical facts contained or incorporated by reference in this prospectus, including statements regarding our future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “will,” “may,” “future,” “plan,” “intend” and “expect” and similar expressions generally identify forward-looking statements. These forward-looking statements are not guarantees and are subject to known and unknown risks, uncertainties and assumptions that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. Although we believe that our plans, intentions and expectations reflected in the forward-looking statements are reasonable, we cannot be sure that they will be achieved. Particular uncertainties that could cause our actual results to be materially different than those expressed in our forward-looking statements include: our history of losses; our inability to receive regulatory approval for our products; later discovery of previously unknown problems; reliance on third parties; competition between us and other companies in the industry; delays in the development of products; our ability to raise additional capital; continued services of our executive management team; and statements of assumption underlying any of the foregoing, as well as other factors set forth under the caption “Risk Factors” on page 6 of this prospectus. All subsequent written and oral forward-looking statements attributable to us, or persons acting on our behalf, are expressly qualified in their entirety by the foregoing. Except as required by law, we undertake no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

USE OF PROCEEDS

9

MARKET FOR We estimate that the net proceeds from this offering will be approximately $18,220,000 based on a public offering price of $4.13 per Unit, after deducting estimated underwriting discounts and estimated offering expenses payable by us and excluding the proceeds, if any, from the exercise of the warrants issued as part of the Units. If the underwriters’ over-allotment option is exercised in full, we estimate that our net proceeds will be approximately $21,010,000 after deducting estimated underwriting discounts and estimated offering expenses payable by us and excluding the proceeds, if any, from the exercise of the warrants issued as part of the Units.

We currently intend to use the net proceeds we receive from this offering to (i) redeem our Bridge Notes in the outstanding amount of $5,146,176, (ii) repurchase our Series A Preferred Stock from our Chief Executive Officer for an aggregate purchase price of approximately $195,000, (iii) hire marketing and sales personnel to support sales of our CaverStem^® and FemCelz^® products, (iv) proceed with a clinical study of 100 patients intended to support the safety and efficacy of our StemSpine® Regenerative Stem Cell Procedure for Treatment of Degenerative Disc Disease, (v) conduct, a Phase I clinical trial for the treatment of stroke utilizing our ImmCelz^TM technology, (vi) continue to develop other products and therapies, and (vii) to fund working capital and general corporate purposes using any remaining amounts.

Based on our planned use of the net proceeds, we estimate such funds, together with our existing cash and cash equivalents, will be sufficient for us to fund our operating expenses and capital expenditure requirements through at least June 2023. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect.

The expected use of the net proceeds from the offering represents our intentions based upon our current plans and business conditions. The amounts we actually expend in these areas, and the timing thereof, may vary significantly from our current intentions and will depend on a number of factors, including the success of research and product development efforts, cash generated from future operations and actual expenses to operate our business.

The amounts and timing of our preclinical and clinical expenditures and the extent of preclinical and clinical development may vary significantly depending on numerous factors, including the status, results and timing of our current preclinical studies and the preclinical studies and clinical trials which we may commence in the future, the product approval process with the FDA and other regulatory agencies, and any new collaborations we may enter into with third parties and any unforeseen cash needs. As a result, we cannot predict with any certainty all of the particular uses for the net proceeds or the amounts that we will actually spend on the uses set forth above. Accordingly, our management will have broad discretion in the application of the net proceeds, and investors will be relying on the judgment of our management regarding the application of the net proceeds of this offering.

The expected net proceeds of this offering will not be sufficient for us to fund any of our product candidates through regulatory approval, and we will need to raise substantial additional capital to complete the development and commercialization of our product candidates.

DIVIDEND POLICY

We have never declared or paid any cash dividends on our common stock and do not anticipate paying any cash dividends on our common stock at any time in the foreseeable future. We currently intend to retain all available funds and any future earnings for use in the operation of our business and do not anticipate paying any dividends on our common stock in the foreseeable future. Any future determination to declare dividends will be made at the discretion of our Board and will depend on, among other factors, our financial condition, operating results, capital requirements, general business conditions, the terms of any future credit agreements and other factors that our Board may deem relevant.

CAPITALIZATION

The following table sets forth our cash and cash equivalents, debt obligations, and capitalization as of September 30, 2021 (i) on an actual basis, and (ii) on a pro forma as adjusted basis to give effect to the issuance and sale of shares of our common stock and public warrants in this offering at a public offering price of $4.13 per Unit, for total net proceeds of approximately $18,220,00 (assuming no exercise of the underwriters’ over-allotment option).

OUR COMMON STOCKBUSINESS

9Overview

We are a commercial stage biotechnology company focused on immunology, urology, neurology and orthopedics using adult stem cell treatments and interrelated regenerative technologies for the treatment of multiple indications. Our existing and pipeline of therapies and products include the following:

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 I diabetes, and heart, liver, kidney and other diseases using various types of stem cells through our ImmCelz, Inc., StemSpine, Inc. and AmnioStem LLC subsidiaries. However, neither ImmCelz Inc., StemSpine Inc. nor AmnioStem LLC have commenced commercial activities.

We currently conduct substantially all of our commercial operations through CMT, which markets and sells our CaverStem^® and FemCelz^® disposable kits utilized by physicians to perform autologous procedures that treat erectile dysfunction and female sexual dysfunction, respectively. Our CaverStem^® and FemCelz^® kits are currently available through physicians at eight locations in the United States.

In addition to our CaverStem^® and FemCelz^® products, we are currently in the process of recruiting clinical sites for our StemSpine^® Regenerative Stem Cell Procedure for the Treatment of Degenerative Disc Disease. Our StemSpine^® treatment is an autologous procedure that utilizes a patient’s own stem cells to treat lower back pain.

In 2020, through our ImmCelz Inc. subsidiary, we began exploring the development of 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. We believe this process endows the immune cells with regenerative properties that may be suitable for the treatment of stroke victims, among other 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.

We are currently primarily focused on expanding the commercial sale and use of our CaverStem^® and FemCelz^® products by physicians in the Unites States and Europe, and commercializing our StemSpine^® treatment for lower back pain. We also recently filed an Investigational New Drug (IND) application with the FDA to treat stroke utilizing our ImmCelz^TM technology. In the future, subject to the availability of capital, we will seek to further develop additional therapeutic products that utilize our proprietary intellectual property.

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 Products

CaverStem® - Erectile Dysfunction Treatment (Commercialized)

CaverStem® is a clinically proven, patented procedure (U.S. Patent No. 8,372,797) that utilizes a patient’s own stem cells to treat erective dysfunction (ED). The procedure has been demonstrated safe and effective in clinical trials, and is geared to the estimated nine million men in the United States that suffer from ED and do not respond to PDE5 inhibitors in drugs such as Viagra and Cialis due to damage to smooth muscle and blood vessels.

Management has determined that CaverStem® is exempt from the FDA premarket review and approval process under Section 361 of the Public Health Service Act (or PHS Act”), as the procedure involves the autologous treatment of a patient with his own cells during the same surgical procedure without intervening processing steps beyond rinsing or cleansing the extracted cells.

Our CaverStem® stem cell treatment consists of a one-hour out-patient visit in a physician’s office. The physician harvests a patient’s stem cells from bone marrow in the hip using a local anesthetic. The extraction device is designed to harvest only the stem cells, while filtering out the red blood cells, thereby eliminating the need for any centrifugation. The stem cells are then injected into the patient’s corpus cavernosum (erectile tissue) to stimulate muscle and blood vessel regeneration. Clinical research data concludes that our CaverStem® treatment results in a marked increase in duration and frequency of erections and the ability to sustain erections until orgasm, with no known treatment-associated adverse events.

We generate revenues through the sale of disposable bone marrow aspiration kits to physicians who use the kits to perform the CaverStem® procedure. We contract with physicians to purchase kits and, in turn, provide exclusivity in their market through our patent protection, marketing support and training.

Our CaverStem® technology is protected by U.S. Patent No. 8,372,797, entitled “Treatment of Erectile Dysfunction by Stem Cell Therapy” which was issued to CMH by the United Stated Patent and Trademark Office (“USPTO”) on February 12, 2013. We acquired this patent and related know-how and technology from CMH in May 2016. CaverStem® is also a U.S. registered trademark (Reg. No. 5716528).

In August 2017, we completed recruitment on a clinical trial of the CaverStem® procedure conducted by the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. Following completion of recruitment and treatment of the study subjects, an independent Institutional Review Board (IRB) overseeing the study validated the procedure as safe. In the same time frame, other worldwide, peer-reviewed and published clinical trials using the same procedure validated the efficacy of the ED treatment. As a result of these two developments, management concluded the CaverStem® procedure is both safe and effective and commenced marketing activities in November of 2017. From November 2017, through September 2019, the data from 40 patients in the clinical trial was combined with data from a 100-patient clinical registry and analyzed. The results were then submitted to the Journal of Translational Medicine for peer-review and publication and subsequently published in its January 2020 edition. The peer-reviewed results validated 100% safety and 85% efficacy of the CaverStem® procedure. This marked the largest ever study of the safety and efficacy of bone marrow stem cells used to tread erectile dysfunction.

We plan to use a portion of the proceeds of this offering to expand our marketing and promotion of CaverStem® both to medical professional and the general public to generate increased CaverStem® sales.

FemCelz® - Female Sexual Function Treatment (Commercialized)

In September 2018, we launched our proprietary FemCelz® procedure for the treatment of the loss of genital sensitivity and dryness experienced by women. The FemCelz® procedure uses the patient’s own stem cells to improve female sexual function, and is similar to the CaverStem® procedure. Management has determined that FemCelz® is exempt from the FDA premarket review and approval process under Section 361 of the PHS Act, as the procedure involves the autologous treatment of a patient with her own cells during the same surgical procedure without intervening processing steps beyond rinsing or cleansing the extracted cells.

Our FemCelz® stem cell treatment consists of a one-hour out-patient visit in a physician’s office. The physician harvests a patient’s stem cells from bone marrow in the hip using a local anesthetic. The extraction device is designed to harvest only the stem cells, while filtering out the red blood cells, thereby eliminating the need for any centrifugation. The cells are then injected into the pubocervical fascia (peri-G-spot), skene’s glands, and around the peri-clitoral to stimulate muscle and blood vessel regeneration.

We generate revenues through the sale of disposable bone marrow aspiration kits to physicians who use the kits to perform the FemCelz® procedure. We contract with physicians to purchase kits and, in turn, provide exclusivity in their market through our patent protection, marketing support and training.

FemCelz® is a U.S. registered trademark (Reg. No. 6107881).

StemSpine® - Regenerative Stem Cell Procedure for the Treatment of Degenerative Disc Disease (Clinical Trials)

Our StemSpine® procedure uses the patient’s own stem cells to reverse the effects of atherosclerosis and treat chronic lower back pain. A recent study reported that that an estimated 2.6 million patients in the U.S. will have suffered from degenerative disc disease in 2021, with the number increasing to close to four million patients in 2028.

Management has determined that StemSpine® is exempt from the FDA premarket review and approval process under Section 361 of the PHS Act, as the procedure involves the autologous treatment of a patient with his or her own cells during the same surgical procedure without intervening processing steps beyond rinsing or cleansing the extracted cells.

Our StemSpine® stem cell treatment consists of a one-hour out-patient visit in a physician’s office. The physician harvests a patient’s stem cells from bone marrow in the hip using a local anesthetic. The extraction device is designed to harvest only the stem cells, while filtering out the red blood cells, thereby eliminating the need for any centrifugation. The cells are then administered into muscles surrounding the area of lower back pain, such as the psoas major muscle to stimulate blood vessel regeneration. New blood vessels increase circulation around the disc and thus stimulates regeneration of the disc.

Lower back pain is the single leading cause of disability worldwide, affecting mobility, functionality and the emotional state. To date, treatment options have ranged from prescription medication, to physical therapy and even acupuncture. Unfortunately, in patients whose lower back pain originates from disc degeneration, existing approved treatments do not address the underlying cause, but only symptoms.

Recent U.S. clinical trials using stem cells administered directly into the disc have shown promise in regenerating injured discs, and by this means reducing pain in some patients. Companies such as Mesoblast Limited and BioRestorative Therapeutics have patient follow-ups as long as three years post injection and show some degree of pain reduction and disc regeneration without adverse effects.

A significant number of patients suffering from lower back pain have deficient circulation in the areas surrounding the discs, which is believed by some to be the initial cause of disc degeneration. Our StemSpine® technology utilizes biologicals to stimulate a process termed angiogenesis, which overcomes the deficient circulation causing disc degeneration.

In May 2017, we formed StemSpine, LLC for the purpose of using stem cells to treat back pain under a patent we acquired from CMH. In June 2017, we filed an additional patent application covering the synergy between intradiscal stem cell injection subsequent to stimulation of perispinal angiogenesis.

In October 2019 we announced the successful completion of a pilot study of 15 patients with over 12 months of data showing safety and efficacy. Evaluation of patients at 30, 60 90, 180, and 360 days revealed significant improvement in mobility and reduction in pain score. The mean pain score (on a scale of 1 to 10, with 10 being most severe), changed from 8.9 at baseline to 4.3 at 30 days, and sustained to 1.8 at 6 months and 1.3 at 12 months, with a gradual reduction in overall pain medication utilization guided by patients’ healthcare teams. No serious adverse effects were noted, with some short-term bruising in two patients at the harvest site. No long term adverse events were reported related to the procedure.

While we have not yet generated any revenues from our StemSpine® procedure, we have commenced physician recruitment in key markets to perform the procedure in a clinical trial of StemSpine® in an effort to demonstrate the efficacy of our procedure to the medical community and generate demand for this procedure. We intend to publish the results of this trial in a clinical registry similar to our data gathering efforts that we used to support our CaverStem® procedure. We will provide disposable kits at no cost to the physician or patient, and reimburse the physicians for their time and effort. In return, the physicians will track the results of the StemSpine® procedures and upload the data onto the clinical registry. We plan to commercialize StemSpine® once we have been able to publish data from the clinical registry supporting the efficacy of StemSpine®, although there can be no assurance that our trials will generate such data.

StemSpine® is a U.S. registered trademark (Reg. No. 5997521).

ImmCelz™ - Universal Donor Stem Cell Therapy for Stroke Treatment (Pre-Clinical Trials)

We are developing our ImmCelz™ technology for the treatment of stroke patients. According to the National Institute of Health, stroke affects approximately 800,000 people in the United States annually alone. Very few treatments are available to stroke victims subsequent to initiation of brain damage.

ImmCelz™ utilizes a patient’s own extracted immune cells that are then “reprogrammed” by culturing them outside the patient’s body with optimized amniotic stem cells. 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 that may be suitable for the treatment of stroke victims. In contrast with 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.

Unlike our CaverStem^®, FemCelz^® and StemSpine® procedures, because the patient’s cells are cultured with amniotic cells prior to reinjection, we will require FDA approval before we can market or sell ImmCelz™. We filed an Investigational New Drug (IND) application (number 27375) with the FDA for a Phase I study of our ImmCelz™ technology to treat stroke in January 2021. The proposed study will involve treatment of four groups of eight patients per group. Treated patients will receive one intravenous injection of ImmCelz™ product at either 0.5 times 10⁶ cells per kilogram; 1 times 10⁶ cells per kilogram; or 2 times 10⁶ cells per kilogram; with the fourth group serving as a control. Patients will be followed for a total of six months with both safety and efficacy being examined.

The particular immune cells we use for ImmCelz™ are “JadiCells™” which were developed by Amit Patel, one of our of our directors. Pursuant to a license agreement we entered into with Jadi Cell LLC, which is owned and controlled by Dr. Patel, we have been granted the right to exploit Jadi Cell’s patent rights (including U.S. Patent Number 9,803,176 and similar patents issued by other countries) and proprietary know how in connection with the enhancement of autologous cells.

We have filed an application with the USPTO to trademark ImmCelz^TM (Ser. No. 88829362).

OvaStem™ - Stem Cell Therapy for Premature Ovarian Failure (Pre-Clinical Trials)

We are developing our OvaStem™ technology for the treatment of female infertility. Our treatment is intended to treat women suffering from infertility induced by factors such as chemotherapy and other non-natural causes, as well as age-associated infertility, and infertility with unexplained causes. In these cases, IVF treatment may not be appropriate as the woman’s ovaries are not able to generate eggs capable of being fertilized. Studies have shown that the introduction of stem cells into dysfunctional ovaries induce fertility, reduce ovarian fibrosis, accelerate maturation of immature oocytes and restore growth factor production damaged by aging and cancer interventions. Accordingly, we believe that our OvaStem™ procedure may be a suitable treatment for these women with damaged ovaries.

The OvaStem™ stem cell treatment will consist of a one-hour out-patient visit in a physician’s office. The physician will harvest a patient’s stem cells from bone marrow in the hip using a local anesthetic. The extraction device will harvest only the stem cells, while filtering out the red blood cells, thereby eliminating the need for any centrifugation. The cells would then be administered into the dysfunctional ovaries.

Like our CaverStem® and FemCelz® procedures, because OvaStem™ will utilize a patient’s own extracted immune cells, management has determined that OvaStem™ will be exempt from the FDA premarket review and approval process under Section 361 of the PHS Act, as the procedure involves the autologous treatment of a patient with her own cells during the same surgical procedure without intervening processing steps beyond rinsing or cleansing the extracted cells.

Before we can commercialize OvaStem™ we will need to conduct clinical studies that demonstrate that OvaStem™ is in fact effective in treating female infertility and restoring ovarian function. However, there can be no assurance as to the outcome of such trials.

Other Products and Services

Additional Indications

We are also exploring the use of our regenerative technologies and/or have filed patents covering treatments for:

Virtual Physician™

We intend to launch Virtual Physician™ as a telehealth platform and Web site to educate, recruit and refer patients for our regenerative procedures in partnership with our national network of medical professionals that perform our regenerative procedures. As we commercialize additional products and procedures, Virtual Physician™ would be expanded to support them. In addition, to reach a wider audience, the platform would also support third-party regenerative products and procedures outside of our proprietary procedures.

Our business model for Virtual Physician™ includes:

Marketing

We market our CaverStem® and FemCelz^TM procedures using a multifaceted marketing approach that includes:

The first product we marketed is the CaverStem® procedure to treat erectile dysfunction, which was initiated in November 2017. We subsequently initiated marketing of FemCelz® in March 2019. The two procedures are now offered in the following eight markets:

To-date, we have recruited physicians by partnering with independent sales representatives who represent the Company to physicians across the United States and Europe. Going forward, management plans to continue to partner with independent sales representatives.

Intellectual Property

We have developed and acquired a robust intellectual property portfolio related to the utilization of stem cells to improve patient lives in the areas of urology, neurology and orthopedics. Our patent portfolio is currently composed of four issued patents and 10 pending patent applications filed in the United States with the USPTO as follows

MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONOPERATIONS

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PROPOSED BUSINESSThis Management’s Discussion and Analysis of Financial Condition and Results of Operations, and other parts of this prospectus contain forward-looking statements that involve risks and uncertainties. All forward-looking statements included in this prospectus are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including those set forth in the section captioned “Risk Factors” on page 6 of this prospectus. The following should be read in conjunction with our audited financial statements included elsewhere herein.

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MANAGEMENTOverview

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We are a commercial stage biotechnology company focused on immunology, urology, neurology and orthopedics using adult stem cell treatments and interrelated regenerative technologies for the treatment of multiple indications. Our existing and pipeline of therapies and products include the following:

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 I diabetes, and heart, liver, kidney and other diseases using various types of stem cells through our ImmCelz, Inc., StemSpine, Inc. and AmnioStem LLC subsidiaries. However, neither ImmCelz Inc., StemSpine Inc. nor AmnioStem LLC have commenced commercial activities.

We currently conduct substantially all of our commercial operations through CMT, which markets and sells our CaverStem^® and FemCelz^® disposable kits utilized by physicians to perform autologous procedures that treat erectile dysfunction and female sexual dysfunction, respectively. Our CaverStem^® and FemCelz^® kits are currently available through physicians at eight locations in the United States.

In addition to our CaverStem^® and FemCelz^® products, we are currently in the process of recruiting clinical sites for our StemSpine^® Regenerative Stem Cell Procedure for the Treatment of Degenerative Disc Disease. Our StemSpine^® treatment is an autologous procedure that utilizes a patient’s own stem cells to treat lower back pain.

In 2020, through our ImmCelz Inc. subsidiary, we began exploring the development of 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. We believe this process endows the immune cells with regenerative properties that may be suitable for the treatment of stroke victims, among other 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.

We are currently primarily focused on expanding the commercial sale and use of our CaverStem^® and FemCelz^® products by physicians in the Unites States and Europe, and commercializing our StemSpine^® treatment for lower back pain. We also recently filed an Investigational New Drug (IND) application with the FDA to treat stroke utilizing our ImmCelz^TM technology. In the future, subject to the availability of capital, we will seek to further develop additional therapeutic products that utilize our proprietary intellectual property.

Results of Operations – For the Three-month Period Ended September 30, 2021 and 2020

Gross Revenue. We generated $10,000 in gross revenue for the three-month period ended September 30, 2021, in comparison with $77,000 for the comparable quarter a year ago. The decrease of $67,000 or 87% reflects the ongoing negative impact of the COVID-19 pandemic.

Cost of Goods Sold. We generated $4,000 cost of goods sold for the three-month period ended September 30, 2021, in comparison with $17,600 for the comparable quarter a year ago. The decrease of $13,600 or 77% reflects the ongoing negative impact of the COVID-19 pandemic on sales.

Gross Profit/(Loss). We generated $6,000 gross profit for the three-month period ended September 30, 2021, in comparison with $59,400 for the comparable quarter a year ago. The decrease of $53,400 or 90% is due to the reduced level of sales in the quarter.

General and Administrative Expenses. General and administrative expenses for the three-month period ended September 30, 2021, totaled $757,235 in comparison with $285,100, for the comparable quarter a year ago. The increase of $472,135 or 166% is primarily due to increases of $78,357 in marketing expenses associated with a re-energized CaverStem^® marketing campaign, $383,612 in stock-based compensation associated with the issued service provider warrants, and an increase of $58,697 in legal fees associated with the bridge loan and S-1 filing offset by a $80,742 reduction in commissions as a result of lower sales.

Amortization Expenses. Amortization expenses for the three-month period ended September 30, 2021, totaled $23,021 in comparison with $16,771, for the comparable quarter a year ago. The increase of $6,250 or 37% is due to the added amortization of the $250,000 Jadi Cell asset.

Research and Development Expenses. There was $59,180 in research and development expenses for the three-month period ended September 30, 2021 in comparison to no expenses for the comparable quarter a year ago. The expenses are associated with our efforts to respond to information requests from the FDA associated with our ImmCelz® IND filing for the treatment of stroke.

Other Income / Expense. Other expense for the three-month period ended September 30, 2021, totaled $1,010,160 in comparison with a gain of $637,322, for the comparable quarter a year ago. The increased expense of $1,647,482, is primarily due to an increase of $1,016,163 in interest expense associated with the retirement of convertible debt identified in Note 2, a loss of $194,044 in derivative liabilities compared to a gain of $926,532 for the comparable quarter a year ago, offset by a gain of $489,157 on extinguished debt.

Net Income/Loss. For the reasons stated above, our net loss for the three-month period ended September 30, 2021, totaled $1,843,596 in comparison to net income of $394,851 for the comparable quarter a year ago.

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Results of Operations – For the Nine-month Period Ended September 30, 2021 and 2020

Gross Revenue. We generated gross revenue of $20,000 for the nine-month period ended September 30, 2021, in comparison with $147,000 for the comparable period a year ago. The decrease of $127,000 or 86% reflects the ongoing negative impact of the COVID-19 pandemic.

Cost of Goods Sold. We generated $8,500 cost of goods sold for the nine-month period ended September 30, 2021, in comparison with $42,596 for the comparable period a year ago. The decrease of $34,096 or 80% is due to the reduction in sales.

Gross Profit/(Loss). We generated $11,500 gross profit for the nine-month period ended September 30, 2021, in comparison with $104,404 for the comparable period a year ago. The decrease of $92,904 or 89% is due to the reduction in sales.

General and Administrative Expenses. General and administrative expenses for the nine-month period ended September 30, 2021, totaled $1,536,479 in comparison with $846,154, for the comparable period a year ago. The increase of $690,325 or 82% is primarily due to increases of $595,380 in stock-based compensation associated with recruitment of Scientific Advisory Board, service providers, and new employee members, $98,988 in legal fees associated with the bridge loan identified in

Note 2 and the S-1 filing identified in Subsequent Events, and a $68,902 increase in marketing expenses associated with a re-energized CaverStem^® marketing campaign offset by $86,242 in reduced commissions as a result of lower sales.

Amortization Expenses. Amortization expenses for the nine-month period ended September 30, 2021, totaled $69,063 in comparison with $50,021, for the comparable period a year ago. The increase of $19,042 or 38% is due to the added amortization of the $250,000 Jadi Cell asset.

Research and Development Expenses. There was $59,180 in research and development expenses for the nine-month period ended September 30, 2021 in comparison to no expenses for the comparable period a year ago. The expenses are associated with our efforts to respond to information requests from the FDA associated with our ImmCelz® IND filing for the treatment of stroke.

Other Income / Expense. Other income for the nine-month period ended September 30, 2021, totaled $24,740,463 in comparison with $3,086,539, for the comparable period a year ago. The increased income of $21,653,924, or 702% is primarily due to an increased gain in the fair value of derivative liabilities of $22,033,774 combined with a gain of $585,601 associated with gains on extinguishment of convertible notes.

Net Income/Loss. For the reasons stated above, our net income for the nine-month period ended September 30, 2021, totaled $23,087,241 in comparison to $2,294,768, for the comparable period a year ago.

Results of Operations – For the Year Ended December 31, 2020, and for the Year Ended December 31, 2019

Gross Revenue. We generated $164,500 in gross revenue for the year ended December 31, 2020 in comparison with $165,500 for the comparable period a year ago. The decrease of $1,000 or 0.6% is primarily due to the effects of the COVID-19 pandemic. Prior to the pandemic, we were experiencing an upward trend is sales. However, from March through June 2020 and then September through December 2020, nearly all elective procedures were halted in the U.S. This resulted in a near cessation of CaverStem^® and FemCelz^® procedures in those time frames. Also, there were a number of incentives offered to new physicians that reduced the average per-unit price.

Cost of Goods Sold. We generated $50,596 in cost of goods sold for the year ended December 31, 2020 in comparison with $45,499 for the comparable period a year ago. The increase of $5,097 or 11.2% was consistent with the per-unit cost. The nearly flat cost of goods sold was primarily due to the COVID-19 pandemic. From March through June 2020 and then September through December 2020, nearly all elective procedures were halted in the U.S. This resulted in a near cessation of CaverStem^® and FemCelz^® procedures in those time frames.

Gross Profit/(Loss). We generated 113,904 in gross profit for the year ended December 31, 2020 in comparison with $120,001 in gross profit for the comparable period a year ago. The decrease of $6,097 or 5.1% is due to the lower sales associated with the COVID-19 pandemic and lower per-unit revenue from new physician promotions.

General and Administrative Expenses. General and administrative expenses for the year ended December 31, 2020, totaled $1,228,739, in comparison with $1,250,169 for the comparable period a year ago. The decrease of $21,430, or 1.7% is primarily due to reduced marketing and travel expenses due to the COVID-19 pandemic offset by increased amortization expenses associated with the StemSpine^® patent acquisition.

Research and Development Expenses. We had no research and development expenses for the years ended December 31, 2020 and 2019. However, we expect our research and development expenses to increase substantially in the future as we seek regulatory approval of our ImmCelz^TM technology to treat stroke, and seek to further develop additional therapeutic products that utilize our proprietary intellectual property.

Operating Loss. For the reasons stated above, our operating loss for the year ended December 31, 2020 was $1,114,835 in comparison with $1,130,168 for the comparable period a year ago.

Other Expense. Other expenses for the year ended December 31, 2020 totaled $35,210,395 in comparison with $7,353,505 for the comparable period a year ago. The increase of $27,856,890, or 378.8% is due to an increase of $28,888,870 in the change in fair value of derivative liabilities offset by a decrease of $665,938 in interest expense compared to a $366,042 loss for the comparable period a year ago. We incurred interest expense calculated on our promissory notes. We recorded the amortization of various debt discounts associated with our convertible promissory notes. The discounts are the result of derivative liabilities which are recorded due to the variability of the notes’ conversion prices. The derivative liabilities are required to be re-measured as of each reporting date.

Net Loss. For the reasons stated above, our net loss for the year ended December 31, 2020 was $36,325,230 in comparison with $8,483,673 for the comparable period a year ago.

Amortization Expense. We acquired a patent (U.S. Patent No. 8,372,797) from CMH on February 2, 2016, in exchange for 123,333 shares of our restricted common stock valued at $100,000. The patent expires in 2026 and we have elected to amortize the patent over a ten-year period on a straight-line basis. On August 25, 2016, we entered into a License Agreement which grants us the exclusive right to all products derived from US Patent No. 7,569,385 for multipotent amniotic fetal stem cells. Under the terms of the license agreement, we paid an initial license fee within 30 days of entering into the agreement. The patent expires in 2026 and we have elected to amortize the patent over a ten-year period on a straight-line basis. On May 17, 2017, we purchased U.S. Patent No. 9,598,673 covering use of various stem cells for treatment of lower back pain from CMH. Under the terms of the agreement, we are required to pay CMH $100,000. The agreement was modified in November 2017 to waive payment of the initial license fee, modify the fee structure and add the ability to convert the outstanding payable balance into common shares. In November 2019, we announced the commercialization of the lower back procedure using a patient’s own cells. This triggered a milestone payment due to CMH in the amount of $300,000. The patent expires in 2027, and we have elected to amortize the patent over a ten-year period on a straight-line basis. In December 2020, we entered into a Patent License Agreement with Jadi Cells, Inc. Execution of the contract triggered a milestone payment due from the Company to Jadi Cells, Inc. in the amount of $250,000. Given the contract execution date of December 28, 2020 no amortization expense was recognized.

Amortization expense of $66,792 was recorded for the year ended December 31, 2020, representing the amortization of the ED, multipotent amniotic fetal stem cell and lower back pain patents based upon the remaining life of the patents. There was $26,950 of amortization expense recorded for the period ended December 31, 2019.

Liquidity and Capital Resources

As of September 30, 2021, we had $2,338,930 of available cash and a working capital deficit of approximately $917,000. In comparison, as of December 31, 2020, we had approximately $98,000 of available cash and a working capital deficit of approximately $40,423,000.

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 $1,054,446 for the nine-month period ended September 30, 2021 in comparison to $491,542 for the comparable period a year ago, an increase of $562,904 or 115%. The increase in cash used in operations was primarily related to a $299,900 increase in payments made to CMH and a $100,669 decrease in accrued expenses.

Net cash used in operating activities was $434,556 for the year ended December 31, 2020 in comparison to $1,213,093 for the year ended December 31, 2019, a decrease of $778,537 or 179%. The decrease in cash used in operations was primarily related to an increase in change in fair value of derivatives liabilities in the year ended December 31, 2020.

Net Cash used in Investing Activities. There was a $200,000 advance to a related party and no investing activity during the nine-month period ended September 30, 2021 and September 30, 2020, respectively.  Cash used in investing activities was $250,000 for the year ended December 31, 2020 in comparison to $0 for the year ended December 31, 2019.

Net Cash from Financing Activities. In the nine-month period ended September 30, 2021, we raised $4,784,790 through the issuance of convertible debt, preferred stock and short-term, non-convertible notes. We spent $1,256,926 on re-payment of notes and debt issuance costs. In the nine-month period ended September 30, 2020, we raised $458,600 primarily through the issuance of convertible debt. The $3,092,764 or 700% increase in cash flows from financing activities were primarily related to the proceeds from short-term, non-convertible notes, issuance of convertible notes and the sale of preferred stock.  Net cash flows from financing activities was $693,920 for the year ended December 31, 2020 in comparison to $997,685 for the year ended December 31, 2019, a decrease of $303,765 or 44%.

Our principal source of liquidity has been funds received from the sale of our common and preferred stock and issuance of notes, including convertible notes. Our experience to-date indicates the lenders are most likely to convert the debt into equity prior to or in lieu of full payment at maturity. Going forward, our short-term funding needs are expected to be satisfied by equity investments, including the proceeds of this offering, funds to be loaned to us by third parties and revenues generated from our CaverStem^® and FemCelz^® procedures. Our long-term liquidity needs are expected to be satisfied from future offerings of our equity securities. It is possible that CMH may provide future financing for us. We do not have any arrangements, agreements, or sources for long-term funding.

In addition to other smaller financing transactions we completed in the last two years, in August 2021, we completed the sale of 15% Original Issue Discount Senior Notes (or “Bridge Notes”) in the aggregate principal amount of $4,456,176.  In connection with the sale of the Bridge Notes, holders of shares of our preferred stock exchanged such preferred stock for additional Bridge Notes in the aggregate principal amount of $690,000.  The Bridge Notes mature on February 11, 2022, subject to the requirement that we redeem the Bridge Notes prior to such date with the net proceeds of any future offering of the Company’s securities, including this public offering.  Accordingly, we will use a portion of the proceeds of the offering to redeem the Bridge Notes.  Pursuant to the Purchase Agreement, we also issued to the purchasers of our Bridge Notes five-year warrants to purchase an aggregate of 363,046 shares of our common stock at an initial exercise price of $14.175 per share, subject to anti-dilution adjustment in the event of future sales of equity by us below the then exercise price, stock dividends, stock splits and other specified events. 

We have continued to realize losses from operations. Upon the closing of this offering, we believe we will have sufficient cash to meet our anticipated operating costs and capital expenditure requirements through June 2023. However, we will need to raise additional capital to support our ongoing operations and continue our clinical trials. We expect to continue to raise additional capital through the sale of our securities from time to time for the foreseeable future to fund the development of our drug product candidates through clinical development, manufacturing and commercialization. Our ability to obtain such additional capital will likely be subject to various factors, including our overall business performance and market conditions. There can be no guarantee that we will be successful in its ability to raise capital to fund future operational and development initiatives. Our need for additional capital as described above raises substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of these uncertainties.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our consolidated financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity capital expenditures or capital resources.

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.

MANAGEMENT

The following table contains information regarding the current members of the Board of Directors and executive officers. The ages of individuals are provided as of November 15, 2021:

(1) Member of the audit committee.

(2) Member of the corporate governance and nominating committee.

(3) Member of the compensation committee.

(4) Appointment to our Board of Directors will be effective upon the closing of this offering.

(5) Will resign as a director of ours immediately prior to the consummation of this offering. 

Timothy Warbington. Mr. Warbington has served as our director and as Chief Executive Officer since February 2016 and has served as a director, Chief Executive Officer and President of CMH since October 2011. He has over 25 years of executive level management experience. Mr. Warbington received a Bachelor’s Degree in Accounting from Arizona State University in 1984. From 1993 through 2007 he owned and operated a multi-million dollar national agricultural (produce) and finance company with annual revenues of $5,000,000 to $12,000,000. Prior to that, he served as Chief Operating Officer of the U.S. subsidiary of a British firm engaged in the international food trade. For eight years, Mr. Warbington has invested in the biotechnology industry and has provided strategic and tactical advice as a consultant to a publicly traded bio-tech firm. In connection with this experience, he has built a network of scientists, physicians and executives to participate as executive officers and directors of CMH.

Mr. Warbington’s experience as an executive, and in particular with respect to biotechnology companies, qualify him to serve as one of our directors.

Donald Dickerson. Mr. Dickerson has served as our director and as Chief Financial Officer and Senior Vice-President since February 2016, and has served as a director and as Vice President and Chief Operating Officer of CMH since June 2014. He received his Masters of Business Administration in Finance from the University of Southern California in May 1992. Mr. Dickerson has worked in a number of management and accounting positions and has experience with companies in the technology, manufacturing and health sciences area. From October 2003 until February 2009 he was employed as a vice-president for JP Morgan Chase in finance; from March 2009 until May 2014 he served as a director for GMT Ventures in finance and operations; and from June 2011 until May 2014 he also served as CFO for Medistem, Inc.

Dr. Thomas Ichim. Dr. Ichim has served as a director of ours since February 2016, and as a director of CMH, and as President of its Biotech Division, since October 2011. Dr. Ichim will resign as director of ours immediately prior to the consummation of this offering.  From 2007 until 2015 he served as Chief Science Officer, Chief Executive Officer, and President, and was a director, of MediStem Inc., a San Diego-based company engaged in development of endometrial regenerative cells which was acquired in 2014 by Intrexon Corporation for $26,000,000. From 2004 until 2007 he served as program manager for Biorasi LLC, a clinical research organization. He also serves as a director of Therapeutic Solutions International, Inc., a publicly-traded company, and previously served as a director of Regen BioPharma, Inc., a publicly traded biotechnology company, from 2012 until 2015. Dr. Ichim sits and has sat on a number of scientific advisory boards, including MyoStim Pacers, San Diego (2011-present); Cromos Pharmaceuticals, Moscow (2010-2019); Orcrist Inc, Edmonton, Canada, Chairman (2008-2010); and Entest Bio, La Mesa, California (2010-2011). He also served as editor for StemCellPatents.com (2007-2009). He has also authored or co-authored over 120 peer reviewed articles and three medical textbooks, and has been named as an inventor on over 200 patent and patent applications.

In 2005 Dr. Ichim received his PhD in Immunology from University of Sciences Arts and Technology, Olveston Monserrat; in 1999 he received a MSc in Microbiology and Immunology from University of Western Ontario, London, Ontario, Canada; and in 1994 he received a BSc in Biology from the University of Waterloo, Waterloo, Ontario, Canada.

Dr. Ichim’s experience and expertise in the field of stem cell research qualify him to serve as one of our directors.

Dr. Amit N. Patel. Dr. Patel has served as a director of ours since February 2016 and a director of CMH since October 2011. Dr. Patel will resign as director of ours immediately prior to the consummation of this offering. He has been a practicing heart surgeon since 2008. Dr. Patel received his medical degree in 1998 from Case Western Reserve University, Cleveland, Ohio. He is currently licensed and practicing cardio-thoracic surgeon in Florida. Dr. Patel has an MD from Case Western Reserve University. He is also a director of Jadi Cell, LLC. Dr. Patel has authored numerous articles in the medical field, including peer reviewed and non-peer reviewed professional journal articles on stem cell research. Since 2008 he has been Director of Clinical Regenerative Medicine.

Dr. Patel’s medical experience and expertise, particularly in the field of stem cell research, qualify him to serve as one of our directors.

Michael H. Finger has agreed to serve as a director upon the closing of this offering.Mr.Finger is the manager and principal member of Alternative Sales Source, LLC, a real estate consulting firm that he founded in 2017.  Prior to founding Alternative Sales Source, LLC, Mr. Finger was active as the founder and principal shareholder of the related companies, Hyland Bay Systems, of which he was Chief Financial Officer, and Hyland Bay Realty, both of which he sold in 2016.  Mr. Finger also founded Cardinal Financial Services, Inc., a national commercial real estate mortgage brokerage firm that he operated for over 20 years until its sale in 2007.  Mr. Finger received his MBA in finance from Colombia University and holds a B.A. in biology from Boston University.

Mr. Finger’s business and financial experience and expertise qualify him to serve as one of our directors.

Susan Snow has agreed to serve as a director upon the closing of this offering. Since January 2018, Ms. Snow has served as Senior VP, Operations at Redhorse, a consulting firm specializing in contacts and relationships with U.S. governmental agencies. Previously, from May 2009 until January 2018, she was a principal at Transitional Finance Partners. She began her professional career and earned her CPA at KPMG, where she spent 4 years before leaving for a Chief Financial Officer role in private industry.

Ms. Snow’s financial and corporate experience and expertise qualify her to serve as one of our directors.

Bruce S. Urdang, Esq. has agreed to serve as a director upon the closing of this offering. Mr. Urdang is an attorney in private practice, having represented clients in real estate and business transactions, and commercial litigation, at the Law Offices of Bruce S. Urdang, J.D. since 1989. Mr. Urdang has also been a professor at Northern Arizona University’s School of Hotel and Restaurant Management since 1989. Mr. Urdang received his J.D. from St. John’s School of Law and holds a B.A. in political science from the State University of New York, Oneonta.

Mr. Urdang’s legal and business experience and expertise qualify him to serve as one of our directors.

Director Independence

Upon completion of this offering, our board of directors will consist of five directors, three of whom will be “independent” as defined under the rules of the Nasdaq Capital Market because they are not employees or executive officers of the Company, and have not been paid more than $120,000 of compensation by the Company in any consecutive 12-month period during the past three years. Tim Warbington, our Chief Executive Officer, is not an independent director due to his employment by us as executive officers.

Audit Committee

Upon completion of this offering, our audit committee will be comprised of Susan Snow, Bruce Urdang and Michael Finger. Susan Snow will serve as the chairperson of our audit committee. Our Board has determined that each member of our audit committee meets the requirements for independence and financial literacy under the applicable rules and regulations of the SEC and the listing standards of the Nasdaq. Our Board has also determined that Susan Snow is an “audit committee financial expert” as defined in the rules of the SEC and has the requisite financial sophistication as defined under the listing standards of the Nasdaq. The responsibilities of our audit committee will include, among other things:

Our audit committee will operate under a written charter, to be effective prior to the completion of this offering, which satisfies the applicable rules and regulations of the SEC and the listing standards of Nasdaq.

Compensation Committee

Upon completion of this offering, our compensation committee will be comprised of Susan Snow, Bruce Urdang and Michael Finger. Bruce Urdang will serve as the chairperson of our compensation committee. Our Board has determined that each member of our compensation committee meets the requirements for independence under the applicable rules and regulations of the SEC and listing standards of Nasdaq. Each member of the compensation committee is a non-employee director, as defined in Rule 16b-3 promulgated under the Exchange Act. The purpose of our compensation committee will be to oversee our compensation policies, plans and benefit programs and to discharge the responsibilities of our Board relating to compensation of our executive officers. The responsibilities of our compensation committee will include, among other things:

Our compensation committee will operate under a written charter, to be effective prior to the completion of this offering, which satisfies the applicable rules and regulations of the SEC and the listing standards of Nasdaq.

Corporate Governance and Nominating Committee

Upon completion of this offering, our corporate governance and nominating committee will be comprised of Susan Snow, Bruce Urdang and Michael Finger. Susan Snow will serve as chairperson of our corporate governance and nominating committee. Our Board has determined that all members of our nominating and corporate governance committee meet the requirements for independence under the applicable rules and regulations of the SEC and listing standards of the Nasdaq. The responsibilities of our nominating and corporate governance committee will include, among other things:

Our nominating and corporate governance committee will operate under a written charter, to be effective prior to the completion of this offering, which satisfies the applicable rules and regulations of the SEC and the listing standards of Nasdaq.

Code of Ethics

The Board adopted a Code of Business Conduct and Ethics that applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and agents and representatives, including consultants. Following the completion of this offering, a copy of the code of ethics and conduct will be available on our website at www.creativemedicaltechnology.com. We intend to disclose future amendments to such code, or any waivers of its requirements, applicable to any principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions or our directors on our website identified above. The inclusion of our website address in this prospectus does not include or incorporate by reference the information on our website into this prospectus.

EXECUTIVE COMPENSATION

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Timothy Warbington, our Chief Executive Officer, and Donald Dickerson, our Chief Financial Officer, served as our only officers during 2020 and 2019. Neither Mr. Warbington nor Mr. Dickerson received compensation directly from us or any subsidiary during the years ended December 31, 2020 or 2019, for services rendered in any capacities to us. During 2020 and 2019, each of Messrs. Warbington and Dickerson were employed by CMH receive their salary from CMH for services performed for us. We reimbursed CMH for the services performed for our company by CMH employees at the rate of $35,000 per month. The following table sets forth the amount of monthly compensation reimbursed to CMH for our named executive officers during 2020 and 2019:

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

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SELLING STOCKHOLDERSThe following table sets forth certain information with respect to the beneficial ownership of our common stock as of November 15, 2021, as adjusted to reflect the sale of common stock offered by us in this offering, for: