Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 1-A/A

TIER II OFFERING

OFFERING STATEMENT UNDER THE SECURITIES ACT OF 1933 CURRENT REPORT

GLOBAL CANCER TECHNOLOGY, INC.

(Exact name of registrant as specified in its charter)

Date: May 18, 2017

16776 Bernardo Center Drive

Suite 203

San Diego, CA 92128

Phone: (619) 818-2411

(Address, including zip code, and telephone number,
including area code, of registrant’s principal executive offices)

Please send copies of all correspondence to:

John Clark, CEO

Global Cancer Technology, Inc.

16776 Bernardo Center Drive

Suite 203

San Diego, CA 92128

(619) 818-2411

jclark@globalcancertechnology.com

(Name, address, including zip code, and telephone number

including area code, of agents for service)

Copies to:

Ronald N. Vance, Esq.

Pearson, Butler & Carson, PLLC

1802 W. South Jordan Parkway

Suite 200

South Jordan, UT 84095

(801) 988-5862

(801) 254-9427 (fax)

ron@pearsonbutler.com

THIS OFFERING STATEMENT SHALL ONLY BE QUALIFIED UPON ORDER OF THE COMMISSION, UNLESS A SUBSEQUENT AMENDMENT IS FILED INDICATING THE INTENTION TO BECOME QUALIFIED BY OPERATION OF THE TERMS OF REGULATION A.

PART I - NOTIFICATION

Part I should be read in conjunction with the attached XML Document for Items 1-6.

PART I – END

PRELIMINARY OFFERING CIRCULAR DATED,

Subject to Completion Dated November 7, 2018

An offering statement pursuant to Regulation A relating to these securities has been filed with the U.S. Securities and Exchange Commission, which we refer to as the Commission.  Information contained in this Preliminary Offering Circular is subject to completion or amendment.  These securities may not be sold nor may offers to buy be accepted before the offering statement filed with the Commission is qualified. This Preliminary Offering Circular shall not constitute an offer to sell or the solicitation of an offer to buy nor may there be any sales of these securities in any state in which such offer, solicitation or sale would be unlawful before registration or qualification under the laws of any such state. We may elect to satisfy our obligation to deliver a Final Offering Circular by sending you a notice within two business days after the completion of our sale to you that contains the URL where the Final Offering Circular or the offering statement in which such Final Offering Circular was filed may be obtained.

GLOBAL CANCER TECHNOLOGY, INC.

16776 BERNARDO CENTER DRIVE, SUITE 203

SAN DIEGO, CA 92128

(619) 818-2411

Up to 1,832,533 SHARES OF COMMON STOCK

NO PAR VALUE PER SHARE

In this public offering we, “Global Cancer Technology”, are offering up to 1,333,333 shares of our common stock at $3.00 per share and our selling shareholders are offering 499,200 shares of our common stock at $3.00 per share. The offering of these shares by us and by the selling shareholders will occur simultaneously. We will not receive any of the proceeds from the sale of shares by the selling shareholders. The primary offering will be conducted on a “best-efforts” basis, which means our directors and officers will use their commercially reasonable best efforts in an attempt to offer and sell the shares. Our directors and officers will not receive any commission or any other remuneration for these sales. In offering the securities on our behalf, the directors and officers will rely on the safe harbor from broker-dealer registration set out in Rule 3a4-1 under the Securities Exchange Act of 1934, as amended.

We reserve the right to retain a registered broker dealer (the “Placement Agent”) in the sale of our shares. The Placement Agent and other broker dealers will receive compensation for sales of the securities offered hereby at a commission rate of up to 10% of the gross proceeds of the offering. Our directors, officers and/or Placement Agent will not sell any of the shares in the secondary offering. Resale shares in the secondary offering may be sold to or through underwriters or dealers, directly to purchasers or through agents designated from time to time by the selling shareholders. For additional information regarding the methods of sale, you should refer to the section entitled “Plan of Distribution” in this offering. There is no minimum number of shares required to be purchased by each investor.

All of the shares being qualified for sale by the Company will be sold at $3.00 per share for the duration of the offering. Assuming all the 1,333,333 shares being offered by the Company are sold, the Company will receive $4,000,000 in gross proceeds. Assuming 1,000,000 shares (75%) being offered by the Company are sold, the Company will receive $3,000,000 in gross proceeds. Assuming 666,666 shares (50%) being offered by the Company are sold, the Company will receive $2,000,000 in gross proceeds. Assuming 333,333 shares (25%) being offered by the Company are sold, the Company will receive $1,000,000 in gross proceeds. There is no escrow of funds or minimum amount we are required to raise from the shares being offered by the Company and any funds received will be immediately available to us. There is no guarantee that we will sell any of the securities being offered in this offering. Additionally, there is no guarantee that this offering will successfully raise enough funds to institute our business plan.

This primary offering will terminate upon the earliest of (i) such time as all of the common stock has been sold pursuant to the Offering Statement or (ii) 365 days from the qualified date of this offering circular, unless extended by our directors for an additional 90 days. We may however, at any time and for any reason terminate the offering.

If all the shares are not sold in the Company’s offering, there is the possibility that the amount raised may be minimal and might not even cover the costs of the offering, which the Company estimates at $50,000. The proceeds from the sale of the securities will be placed directly into the Company’s account; any investor who purchases shares will have no assurance that any monies, beside their own, will be subscribed to the offering circular. All proceeds from the sale of the securities are non-refundable, except as may be required by applicable laws. All expenses incurred in this offering are being paid for by the Company.

There is currently no trading market for our securities. There is no assurance that a regular trading market will develop, or if developed, that it will be sustained. Therefore, a shareholder may be unable to resell his securities in our company.

The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, which became law in April 2012 and will be subject to reduced public company reporting requirements.

THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION DOES NOT PASS UPON THE MERITS OF OR GIVE ITS APPROVAL TO ANY SECURITIES OFFERED OR THE TERMS OF THE OFFERING, NOR DOES IT PASS UPON THE ACCURACY OR COMPLETENESS OF ANY OFFERING CIRCULAR OR OTHER SELLING LITERATURE. ANY REPRESENTATION TO THE CONTRARY IS UNLAWFUL.

AN OFFERING STATEMENT PURSUANT TO REGULATION A RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE COMMISSION. INFORMATION CONTAINED IN THIS PRELIMINARY OFFERING CIRCULAR IS SUBJECT TO COMPLETION OR AMENDMENT. THESE SECURITIES MAY NOT BE SOLD, NOR MAY OFFERS TO BUY BE ACCEPTED BEFORE THE OFFERING STATEMENT FILED WITH THE COMMISSION IS QUALIFIED. THIS PRELIMINARY OFFERING CIRCULAR SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY NOR MAY THERE BE ANY SALES OF THESE SECURITIES IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL BEFORE REGISTRATION OR QUALIFICATION UNDER THE LAWS OF SUCH STATE. THE COMPANY MAY ELECT TO SATISFY ITS OBLIGATION TO DELIVER A FINAL OFFERING CIRCULAR BY SENDING YOU A NOTICE WITHIN TWO BUSINESS DAYS AFTER THE COMPLETION OF A SALE TO YOU THAT CONTAINS THE URL WHERE THE FINAL OFFERING CIRCULAR OR THE OFFERING STATEMENT IN WHICH SUCH FINAL OFFERING CIRCULAR WAS FILED MAY BE OBTAINED. 

GENERALLY, NO SALE MAY BE MADE TO YOU IN THIS OFFERING IF THE AGGREGATE PURCHASE PRICE YOU PAY IS MORE THAN 10% OF THE GREATER OF YOUR ANNUAL INCOME OR NET WORTH. DIFFERENT RULES APPLY TO ACCREDITED INVESTORS AND NON-NATURAL PERSONS. BEFORE MAKING ANY REPRESENTATION THAT YOUR INVESTMENT DOES NOT EXCEED APPLICABLE THRESHOLDS, WE ENCOURAGE YOU TO REVIEW RULE 251(D)(2)(I)(C) OF REGULATION A. FOR GENERAL INFORMATION ON INVESTING, WE ENCOURAGE YOU TO REFER TO WWW.INVESTOR.GOV.

THESE SECURITIES ARE SPECULATIVE AND INVOLVE A HIGH DEGREE OF RISK. YOU SHOULD PURCHASE SHARES ONLY IF YOU CAN AFFORD THE COMPLETE LOSS OF YOUR INVESTMENT. PLEASE REFER TO ‘RISK FACTORS’ BEGINNING ON PAGE 5.

THE COMMISSION DOES NOT PASS UPON THE MERITS OF OR GIVE ITS APPROVAL TO ANY SECURITIES OFFERED OR THE TERMS OF THE OFFERING, NOR DOES IT PASS UPON THE ACCURACY OR COMPLETENESS OF ANY OFFERING CIRCULAR OR OTHER SOLICITATION MATERIALS. THESE SECURITIES ARE OFFERED PURSUANT TO AN EXEMPTION FROM REGISTRATION WITH THE COMMISSION; HOWEVER, THE COMMISSION HAS NOT MADE AN INDEPENDENT DETERMINATION THAT THE SECURITIES OFFERED ARE EXEMPT FROM REGISTRATION.

You should rely only on the information contained in this offering circular and the information we have referred you to. We have not authorized any person to provide you with any information about this Offering, the Company, or the shares of our Common Stock offered hereby that is different from the information included in this offering circular. If anyone provides you with different information, you should not rely on it.

The Company is following the “Offering Circular” format of disclosure set forth under Part II of the Offering Statement on Form 1-A of Regulation A.

The date of this offering circular is November __, 2018

GLOBAL CANCER TECHNOLOGY, INC.

OFFERING CIRCULAR

TABLE OF CONTENTS

You should rely only on the information contained in this offering circular or contained in any free writing offering circular filed with the Securities and Exchange Commission. We have not authorized anyone to provide you with additional information or information different from that contained in this offering circular filed with the Securities and Exchange Commission. We take no responsibility for and can provide no assurance as to the reliability of, any other information that others may give you. We are offering to sell, and seeking offers to buy, our common stock only in jurisdictions where offers and sales are permitted. The information contained in this offering circular is accurate only as of the date of this offering circular, regardless of the time of delivery of this offering circular or any sale of shares of our common stock. Our business, financial condition, results of operations and prospects may have changed since that date.

GLOBAL CANCER TECHNOLOGY, INC.

OFFERING CIRCULAR

SUMMARY

In this offering circular, ‘‘GCT,’’ the “Company,’’ ‘‘we,’’ ‘‘us,’’ and ‘‘our,’’ refer to Global Cancer Technology, Inc., unless the context otherwise requires. Unless otherwise indicated, the term ‘‘fiscal year’’ refers to our fiscal year ending December 31^st. Unless otherwise indicated, the term ‘‘common stock’’ refers to shares of the Company’s common stock.

This offering circular, and any supplement to this offering circular include “forward-looking statements”. To the extent that the information presented in this offering circular discusses financial projections, information or expectations about our business plans, results of operations, products or markets, or otherwise makes statements about future events, such statements are forward-looking. Such forward-looking statements can be identified by the use of words such as “intends”, “anticipates”, “believes”, “estimates”, “projects”, “forecasts”, “expects”, “plans” and “proposes”. Although we believe that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. These include, among others, the cautionary statements in the “Risk Factors” section and the “Management’s Discussion and Analysis of Financial Position and Results of Operations” section in this offering circular.

This summary only highlights selected information contained in greater detail elsewhere in this offering circular. This summary may not contain all the information that you should consider before investing in our common stock. You should carefully read the entire offering circular, including “Risk Factors” beginning on Page 5, and the financial statements, before making an investment decision.

Generally, no sale may be made to you in this offering if the aggregate purchase price you pay is more than 10% of the greater of your annual income or net worth. Different rules apply to accredited investors and non-natural persons. Before making any representation that your investment does not exceed applicable thresholds, we encourage you to review Rule 251(d)(2)(i)(C) of Regulation A. For general information on investing, we encourage you to refer to www.investor.gov.

Sale of these shares will commence within two calendar days of the qualification date and it will be a continuous offering pursuant to Rule 251(d)(3)(i)(F).

The Company

Our company was formed by John Clark, our sole officer and director, and principal shareholder, to acquire a portfolio of various medical licenses for unique and promising patents and intellectual properties. The company has acquired licenses from the University of California, San Diego, John Moores Cancer Center and from the University of Washington. In addition, we hold an exclusive technology license from American Radiosurgery, Inc., an affiliated entity, to promote and sell high technology radiosurgery and cancer treatment products. We are a startup stage company focused on the following operational areas:

Each existing subsidiary was established to develop and commercialize a specific technology. NanoMed Tracking was established to commercialize our technology to label and track hospital instruments with Nano Quantum Dots, while MCW Pharmaceuticals was established to commercialize our intellectual property regarding UCN-01. We presently intend to develop each subsidiary’s licensed technology and, if warranted, introduce it to market.

Our principal executive offices are located at 16776 Bernardo Center Drive, Suite 203, San Diego, CA 92128, and our telephone number is (619) 818-2411. Our website is www.globalcancertechnology.com. Information on our website or any other website is not incorporated by reference into, and does not constitute a part of, this offering circular.

Risks Affecting Us

Our business will be subject to numerous risks and uncertainties, including those described in “Risk Factors” immediately following this offering circular summary and elsewhere in this offering circular. These risks represent challenges to the successful implementation of our strategy and to the growth and future profitability of our business. These risks include, but are not limited to, the following:

Emerging Growth Company Status

We are an “emerging growth company” as defined in Section 2(a)(19) of the Securities Act of 1933, as amended (the “Securities Act”), as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As such, we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We intend to take advantage of all of these exemptions.

In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards, and delay compliance with new or revised accounting standards until those standards are applicable to private companies. We have elected to take advantage of the benefits of this extended transition period.

We could be an emerging growth company until the last day of the first fiscal year following the fifth anniversary of our first common equity offering, although circumstances could cause us to lose that status earlier if our annual revenues exceed $1.0 billion, if we issue more than $1.0 billion in non-convertible debt in any three-year period or if we become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act.

THE OFFERING

You should rely only upon the information contained in this offering circular. We have not authorized anyone to provide you with information different from that which is contained in this offering circular. We are offering to sell common stock and seeking offers to common stock only in jurisdictions where offers and sales are permitted.

RISK FACTORS

Please consider the following risk factors and other information in this offering circular relating to our business before deciding to invest in our common stock.

This offering and any investment in our common stock involves a high degree of risk. You should carefully consider the risks described below and all of the information contained in this offering circular before deciding whether to purchase our common stock. If any of the following risks occur, our business, financial condition and results of operations could be harmed. The trading price of our common stock could decline due to any of these risks, and you may lose all or part of your investment.

We consider the following to be the material risks for an investor regarding this offering. Our company should be viewed as a high-risk investment and speculative in nature. An investment in our common stock may result in a complete loss of the invested amount.

An investment in our common stock is highly speculative, and should only be made by persons who can afford to lose their entire investment in us. You should carefully consider the following risk factors and other information in this offering circular before deciding to become a holder of our common stock. If any of the following risks actually occur, our business and financial results could be negatively affected to a significant extent.

Risks Related to Our Company and its Business:

Our independent auditor has stated there is substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing.

Our financial statements as of and for the year ended December 31, 2017 and 2016, were prepared assuming that we would continue as a going concern. Our significant losses from operations as of December 31, 2017, raised substantial doubt about our ability to continue as a going concern. If the going-concern assumption were not appropriate for our financial statements, then adjustments would be necessary to the carrying values of the assets and liabilities, the reported revenues and expenses, and the balance sheet classifications used. Since December 31, 2017, we have continued to experience losses from operations. We have no commitments for future financings and we anticipate that we will require additional funding to commence principal business operations. Our ability to continue as a going concern is subject to our ability to generate a profit and/or obtain necessary funding from outside sources, including obtaining additional funding from the sale of our securities. Our continued net operating losses and stockholders’ deficiency increase the difficulty in meeting such goals and there can be no assurances that such methods will prove successful.

We have an absence of historical revenues and no current prospects for future revenues. We also have a history of losses which we expect to continue into the future. In the event our current cash resources are insufficient to meet our obligations through the startup stage, we will either have to suspend or cease operations, in which case you will lose your investment.

We have been engaged in the development of medical devices and technology since our inception as a Texas company in 2013 and have not generated any historical revenues relating to our primary business activities. We have incurred cumulative net losses of $888,681 from these activities through June 30, 2018 and anticipate a net loss until we are able to commence principal operations, if ever. During this startup stage we have no source of funding to satisfy our cash needs except for our existing cash resources, which management estimates will be sufficient to meet our cash for approximately three months. In addition, we will require additional funding to meet our operating expenses and to implement our business plans until we generate revenues from operations. We have no confirmed source for future funding. If we do not begin to generate revenues or find alternate sources of capital before our current cash resources expire, we will either have to suspend or cease operations, in which case you will lose your investment.

Any future financing may result in ownership dilution to our existing shareholders and may grant rights to investors more favorable than the rights currently held by our existing shareholders.

If we raise additional capital by issuing equity, equity-related or convertible securities, the economic, voting and other rights of our existing shareholders may be diluted, and those newly-issued securities may be issued at prices that are at a significant discount to current value or then prevailing market prices. In addition, any such newly issued securities may have rights superior to those of our common stock. If we obtain additional capital through collaborative arrangements, we may be required to relinquish greater rights to our technologies or products than we might otherwise have or become subject to restrictive covenants that may affect our business.

Each of our current licensed products is in an early stage of development and we may never succeed in developing and/or commercializing them. If we are unable to commercialize these licensed products, or any future products, or if we experience significant delays in doing so, our business may fail.

We intend to invest a significant portion of our efforts and financial resources in our current licensed products and depend heavily on their success. We need to devote significant additional research and development, financial resources and personnel to develop these as commercially products, obtain regulatory approvals, if necessary, and establish a sales and marketing infrastructure. We are likely to encounter hurdles and unexpected issues as we proceed in the development of our licensed products. There are many reasons that we may not succeed in our efforts to develop these products, including the possibility that our products will be deemed ineffective or unsafe; our products will be too expensive to manufacture or market or will not achieve broad market acceptance; others will hold proprietary rights that will prevent us from marketing our products; or our competitors will market products that are perceived as equivalent or superior.

Our business is subject to substantial competition and could be adversely affected if we are unable to compete effectively in the industry.

The cancer and medical technology industry is highly competitive. Universities and others with research facilities and programs typically license their technology and patent rights to others to commercialize. We face competition from these universities and other research facilities and those to whom they license their technology, particularly in the medical field. In many instances, our competitors have longer operating histories, greater financial resources, and marketing avenues available to them. If we are unable to compete effectively in the cancer and medical technology industry, our business, prospects, results of operations and financial condition could be materially and adversely affected.

The loss of or inability to retain key personnel could materially adversely affect our operations.

Our management includes a select group of experienced medical and technology professionals, particularly our CEO, John Clark, who have been instrumental in acquiring and developing our current licensed products. The success of our operations will, in part, depend on the successful continued involvement of these individuals. If these individuals leave the employment of or engagement with us, then our ability to operate will be negatively impacted. There can be no assurance that we will be successful in retaining key personnel.

Risks Related to Our Intellectual Property

We hold certain intellectual property rights and intend to acquire additional intellectual property rights in the future. Our success will be dependent in large part on safeguarding our intellectual property rights.

We have licenses which we intend to use to develop our business plan. Our business plan is to acquire additional patent licensing rights, or other rights which may not be protected by patents. Our commercial success will depend to a significant degree on our ability to:

Failure to obtain adequate patent protection for our products, the failure of our licensors to protect our licensed patent rights, or the failure to protect our existing patent rights, may impair our ability to be competitive. The availability of infringing products in markets where we have patent protection, or the availability of competing products in markets where we do not have adequate patent protection, could erode the market for our products, negatively impact the prices we can charge for our licensed products, and harm our reputation if infringing or competing products are manufactured to inferior standards.

Failure to maintain our licenses would have material impact on our business.

We hold licenses from universities and intend to seek additional licenses in the future to implement our business plan. If the parties granting these licenses were to determine that we have failed to comply with the licensure requirements, they have the authority to deny, suspend or revoke our licenses, or cause them to be non-exclusive. If our licenses were suspended or revoked, we would no longer be able to operate our proposed business to develop and market the licensed products. Any of these actions by the licensor would negatively impact our proposed business and could result in the termination of proposed operations.

Patents acquired by us may not be valid or enforceable and may be challenged by third parties.

We cannot assure you that any patents issued or licensed to us would be held valid by a court or administrative body or that we would be able to successfully enforce our patents against infringers, including our competitors. The issuance of a patent is not conclusive as to its validity or enforceability, and the validity and enforceability of a patent is susceptible to challenge on numerous legal grounds. Challenges raised in patent infringement litigation brought by or against us may result in determinations that patents that have been issued or licensed to us or any patents that may be issued to us or our licensors in the future are invalid, unenforceable or otherwise subject to limitations. In the event of any such determinations, third parties may be able to use the discoveries or technologies claimed in these patents without paying licensing fees or royalties to us, which could significantly diminish the value of our intellectual property and our competitive advantage. Even if our patents are held to be enforceable, others may be able to design around our patents or develop products similar to our products that are not within the scope of any of our patents.

In addition, enforcing the patents that have been licensed to us and any patents that may be issued to us in the future against third parties may require significant expenditures regardless of the outcome of such efforts. Our existing license agreements require us to pay for or reimburse the licensor for the costs of defending the patents. Our inability to enforce our patents against infringers and competitors may impair our ability to be competitive and could have a material adverse effect on our business.

If we are not able to protect and control unpatented trade secrets, know-how and other technological innovation, we may suffer competitive harm.

We may also rely on unpatented technology, trade secrets, confidential information and proprietary know-how to protect our technology and maintain any future competitive position, especially when we do not believe that patent protection is appropriate or can be obtained. Trade secrets are difficult to protect. In order to protect proprietary technology and processes, we rely in part on confidentiality and intellectual property assignment agreements with our employees, consultants and others. These agreements generally provide that the individual must keep confidential and not disclose to other parties any confidential information developed or learned by the individual during the individual’s relationship with us except in limited circumstances. These agreements generally also provide that we shall own all inventions conceived by the individual in the course of rendering services to us. These agreements may not effectively prevent disclosure of confidential information or result in the effective assignment to us of intellectual property and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information or other breaches of the agreements. In addition, others may independently discover trade secrets and proprietary information that have been licensed to us or that we own, and in such case, we could not assert any trade secret rights against such party.

Enforcing a claim that a party illegally obtained and is using trade secrets that have been licensed to us or that we own is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets. Costly and time-consuming litigation could be necessary to seek to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could have a material adverse effect on our business. Moreover, some of our academic institution licensors, collaborators and scientific advisors have rights to publish data and information to which we have rights. If we cannot maintain the confidentiality of our technologies and other confidential information in connection with our collaborations, our ability to protect our proprietary information or obtain patent protection in the future may be impaired, which could have a material adverse effect on our business.

Risks Related to Our Common Stock

There is no public market for our common stock.

There is currently no public market for our common stock. We intend to seek a brokerage firm to make application for trading of our stock in the over-the-counter market through a quotation on an OTC Markets platform. We have no agreements or arrangements with any brokerage firm and we may not be able to locate a suitable firm to make the application. Any application may require a significant amount of time to process and we cannot assure you when or if a trading market for our stock will develop. Further, if there are insufficient buyers in any future market, holders of common stock may not be able to sell their shares, or if so, at substantially reduced prices to posted market prices.

The beneficial ownership of our common stock is concentrated among existing executive officers and directors.

Our Chairman and CEO, John Clark, owns beneficially, in the aggregate, approximately 85.7% of the issued and outstanding common stock. As a result, Mr. Clark will be able to exercise a significant level of control over all matters requiring shareholder approval, including the election of directors, amendments to our Articles of Incorporation, and approval of significant corporate transactions. This control could have the effect of delaying or preventing a change of control or changes in management and will make the approval of certain transactions difficult or impossible without the support of these shareholders.

Any future public trading market for our common stock will likely be volatile and will likely result in higher spreads in stock prices.

We intend to apply for quotation of our common stock for trading in the over-the-counter market. The over-the-counter market for securities has historically experienced extreme price and volume fluctuations during certain periods. These broad market fluctuations and other factors, such as our ability to implement our business plan, as well as economic conditions and quarterly variations in our results of operations, may adversely affect the market price of our common stock. In addition, the spreads on stock traded through the over-the-counter market are generally unregulated and higher than on stock exchanges, which means that the difference between the price at which shares could be purchased by investors on the over-the-counter market compared to the price at which they could be subsequently sold would be greater than on these exchanges. Significant spreads between the bid and asked prices of the stock could continue during any period in which a sufficient volume of trading is unavailable or if the stock is quoted by an insignificant number of market makers. Our trading volume may not be sufficient to significantly reduce this spread, or we may not have sufficient market makers to affect this spread. These higher spreads could adversely affect investors who purchase the shares at the higher price at which the shares are sold, but subsequently sell the shares at the lower bid prices quoted by the brokers. Unless the bid price for the stock increases and exceeds the price paid for the shares by the investor, plus brokerage commissions or charges, shareholders could lose money on the sale. For higher spreads such as those on over-the-counter stocks, this is likely a much greater percentage of the price of the stock than for exchange listed stocks. There is no assurance that at the time the shareholder wishes to sell the shares, the bid price will have sufficiently increased to create a profit on the sale.

Because our shares will likely be designated as “penny stock”, broker-dealers will be less likely to trade in our stock due to, among other items, the requirements for broker-dealers to disclose to investors the risks inherent in penny stocks and to make a determination that the investment is suitable for the purchaser.

If we are able to develop a public trading market for our common stock, our shares will likely be designated as “penny stock” as defined in Rule 3a51-1 promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and thus may be more illiquid than shares not designated as penny stock. The SEC has adopted rules which regulate broker-dealer practices in connection with transactions in “penny stocks.” Penny stocks are defined generally as: non-Nasdaq equity securities with a price of less than $5.00 per share; not traded on a “recognized” national exchange; or in issuers with net tangible assets less than $2,000,000, if the issuer has been in continuous operation for at least three years, or $10,000,000, if in continuous operation for less than three years, or with average revenues of less than $6,000,000 for the last three years. The penny stock rules require a broker-dealer to deliver a standardized risk disclosure document prepared by the SEC, to provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction, monthly account statements showing the market value of each penny stock held in the customer’s account, to make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity, if any, in the secondary market for a stock that is subject to the penny stock rules. Since our securities are subject to the penny stock rules, investors in the shares may find it more difficult to sell their shares. Many brokers have decided not to trade in penny stocks because of the requirements of the penny stock rules and, as a result, the number of broker-dealers willing to act as market makers in such securities is limited. The reduction in the number of available market makers and other broker-dealers willing to trade in penny stocks may limit the ability of purchasers in this offering to sell their stock in any secondary market. These penny stock regulations, and the restrictions imposed on the resale of penny stocks by these regulations, could adversely affect our stock price.

We have not paid, and do not intend to pay in the near future, dividends on our common shares and therefore, unless our common stock appreciates in value, our shareholders may not benefit from holding our common stock.

We have not paid any cash dividends since inception. Although we anticipate allocating funds for payment of dividends from future earnings, if any, we do not anticipate this occurring until we establish our primary business operations, of which there is no assurance. Therefore, any return on the investment made in our shares of common stock will likely be dependent initially upon the shareholder’s ability to sell our common shares in the open market, if one should develop, at prices exceeding the amount paid for our common shares and broker commissions on the sales.

The Shares sold in this Offering will be offered simultaneously with sales of common shares by the selling stockholders, which may adversely affect our ability to sell all of the shares in the primary offering by us.

We have not limited the number or timing of the offers and sales of the shares by the selling stockholders, which means that they may sell their shares at the same time as we are offering shares in our primary offering of up to $4,000,000. To the extent selling stockholders shares are sold prior to all of the shares being offered by the Company, this may reduce or decrease the number of shares we are able to sell to raise funds, which could have a negative impact on our plans to finance our business operations from these funds. In particular, if a market for our stock develops during this offering and the market price of the shares is lower than the offering price by us in this offering, investors may decide to purchase shares in the open market rather than from us in this offering.

We are an “emerging growth company,” and will be able take advantage of reduced disclosure requirements applicable to “emerging growth companies,” which could make our common stock less attractive to investors.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or JOBS Act, and, for as long as we continue to be an “emerging growth company,” we intend to take advantage of certain exemptions from various reporting requirements applicable to other public companies but not to “emerging growth companies,” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We could be an “emerging growth company” for up to five years, or until the earliest of (i) the last day of the first fiscal year in which our annual gross revenues exceed $1 billion, (ii) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock that is held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter, or (iii) the date on which we have issued more than $1 billion in non-convertible debt during the preceding three year period. We cannot predict if investors will find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as a result of any choices to reduce future disclosure, there may be a less active trading market for our common stock and our stock price may be more volatile.

The prior issuances of shares by us may have been issued without a valid exemption from registration which may subject us to rescission of the issuance of the shares and potential liability in the event an exemption from registration is not available for the issuance.

Since our inception we have sold our shares of common stock primarily, if not solely to persons who designated themselves as accredited investors, many of whom indicated their qualification as accredited investors based upon the individual net worth qualification. Some of these investors mistakenly included the value of their primary residence in calculating their net worth, which recent amendments to Rule 501(a) of Regulation D prohibited. Some shares were sold prior to the conversion of the predecessor limited liability company to the Nevada corporation. Therefore, these sales may not have qualified for exemption under Rule 506(b) or other exemptions from the registration requirements of the Securities Act or state securities laws.

In the event we are found to have offered and sold such shares in transactions for which exemption from registration was not available, such shares may have been offered in violation of the registration provisions of Section 5 of the Securities Act. In that event, investors may have rescission rights to recover their purchase price, plus interest and attorney’s fees, depending upon their state of residence. Nevertheless, we believe the exposure to possible rescission by these investors to be minimal, especially since these investors have indicated their desire to sell some or all of their shares in the open market.

We failed to timely file notices on Form D of our prior nonpublic offerings under Rule 506(b) and as such may be subject to disqualification from future reliance on this exemption from registration if the SEC were to obtain a judgment or decree enjoining us for failure to file these notices.

From November 2015 through June 2018 we made unregistered sales of securities under Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated by the SEC thereunder. We failed to file notices of these sales as required under Rule 503 of Regulation D. As such, the SEC may act against us to enjoin us from future violations of this requirement. If orders or decrees are obtained by the SEC against us, Rule 507 of Regulation D would prohibit us from relying on Rule 504 or 506 of Regulation D, which could materially affect our ability to secure funding in the future.

We have not paid dividends in the past and have no immediate plans to pay dividends.

We plan to reinvest all of our earnings, to the extent we have earnings, in order to market our products and to cover operating costs and to otherwise become and remain competitive. We do not plan to pay any cash dividends with respect to our securities in the foreseeable future. We cannot assure you that we would, at any time, generate sufficient surplus cash that would be available for distribution to the holders of our common stock as a dividend. Therefore, you should not expect to receive cash dividends on our common stock.

Investors cannot withdraw funds once invested and will not receive a refund.

Investors do not have the right to withdraw invested funds. Subscription payments will be held in our corporate bank account if the subscription agreements are in good order and we accept the investor’s investment. Therefore, once an investment is made, investors will not have the use or right to return of such funds.

This is a fixed price offering and the fixed offering price may not accurately represent the current value of us or our assets at any particular time. Therefore, the purchase price you pay for shares may not be supported by the value of our assets at the time of your purchase.

This is a fixed price offering, which means that the offering price for our shares is fixed and will not vary based on the underlying value of our assets at any time. Our board of directors, in consultation with our Placement Agent, has determined the offering price in its sole discretion. The fixed offering price for our shares has not been based on appraisals of any assets we own or may own, or of our company as a whole, nor do we intend to obtain such appraisals. Therefore, the fixed offering price established for our shares may not be supported by the current value of our company or our assets at any particular time.

The entire amount of your purchase price for your shares may not be available for investment in our company.

A portion of the offering proceeds may be used to pay selling commissions of up to ten percent (10%) of the offering proceeds to a placement agent, which it may re-allow and pay to participating broker-dealers, who sell shares. Thus, a portion of the gross amount of the offering proceeds may not be available for investment in our company.

If investors successfully seek rescission, we would face severe financial demands that we may not be able to meet.

Our shares have not been registered under the Securities Act of 1933, or the Securities Act, and are being offered in reliance upon the exemption provided by Section 3(b) of the Securities Act and Regulation A promulgated thereunder. We represent that this Offering Statement does not contain any untrue statements of material fact or omit to state any material fact necessary to make the statements made, in light of all the circumstances under which they are made, not misleading. However, if this representation is inaccurate with respect to a material fact, if this offering fails to qualify for exemption from registration under the federal securities laws pursuant to Regulation A, or if we fail to register the shares or find an exemption under the securities laws of each state in which we offer the shares, each investor may have the right to rescind his, her or its purchase of the shares and to receive back from the Company his, her or its purchase price with interest. Such investors, however, may be unable to collect on any judgment, and the cost of obtaining such judgment may outweigh the benefits. If investors successfully seek rescission, we would face severe financial demands we may not be able to meet and it may adversely affect any non-rescinding investors.

We may invest or spend the proceeds of this offering in ways with which you may not agree or in ways which may not yield a return.

We currently intend to use the net proceeds we receive from this offering primarily for commercializing our instrument marking technology, pre-clinical work on the nanocriystal scintillator and UCN-01, complete the design of the RGS orbiter and software, process a research grant to the University of Washington for the HIFU+, and working capital needs of the Company. Our management will have considerable discretion in the application of the net proceeds, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used appropriately. Investors in this offering will need to rely upon the judgment of our management with respect to the use of proceeds. If we do not use the net proceeds that we receive in this offering effectively, our business, financial condition, results of operations and prospects could be harmed, and the market price of our common stock could decline.

DILUTION

Dilution means a reduction in value, control or earnings of the shares of Common Stock the investor owns.

An early-stage company typically sells its shares (or grants options to purchase its shares) to its founders and early employees at a very low cash cost, because they are, in effect, putting their “sweat equity” into the company. When the company seeks cash investments from outside investors, like you, the new investors typically pay more for the shares than the founders or earlier investors, which means that the cash value of your stake is diluted.

The Shares of Common Stock will be sold in this Offering for $3.00 per share. Pursuant to its Articles of Incorporation, as amended, the Company has the authority to issue up to 100,000,000 shares of Common Stock. At the time of this Offering, 11,551,200 shares of Common Stock are issued or outstanding. The Company has not authorized any shares of preferred stock and does not have any preferred stock outstanding. In addition, as of the date hereof, the Company has not granted options to employees and others to purchase shares of the Company’s Common Stock. The price at which future options may be granted to purchase Common Stock will be determined as of the date of the grant of future options.

PLAN OF DISTRIBUTION

This Offering Statement is part the Form 1-A that we filed with the SEC, using a continuous offering process. Periodically, as we have material developments, we will provide an Offering Statement supplement that may add, update or change information contained in this Offering Statement. Any statement that we make in this Offering Statement will be modified or superseded by any inconsistent statement made by us in a subsequent Offering Statement supplement.

Pricing of the Offering

Prior to the offering, there has been no public market for our common shares. The initial public offering price of $3.00 per share was arbitrarily chosen by management. There is no relationship between this price and our assets, earnings, book value or any other objective criteria of value. The principal factors considered in determining the initial public offering price include:

Investment Limitations

Generally, no sale may be made to you in this offering if the aggregate purchase price you pay is more than 10% of the greater of your annual income or net worth (please see below on how to calculate your net worth). Different rules apply to accredited investors and non-natural persons. Before making any representation that your investment does not exceed applicable thresholds, we encourage you to review Rule 251(d)(2)(i)(C) of Regulation A. For general information on investing, we encourage you to refer to www.investor.gov.

Because this is a Tier 2, Regulation A Offering, most investors must comply with the 10% limitation on investment in the Offering. The only investor in this offering exempt from this limitation is an “accredited investor” as defined under Rule 501 of Regulation D under the Securities Act (an “Accredited Investor”). If you meet one of the following tests you should qualify as an Accredited Investor:

Offering Period and Expiration Date

Our offering will terminate upon the earliest of (i) such time as all of the common stock has been sold pursuant to the Offering Statement or (ii) 365 days from the qualified date of this offering circular unless extended by our Board of Directors for an additional 90 days. We may however, at any time and for any reason terminate the offering.

Procedures for Subscribing

Any potential investor will have ample time to review the subscription agreement, along with their counsel, prior to making any final investment decision. We shall only deliver such subscription agreement upon request after a potential investor has had ample opportunity to review this Offering Statement.

Right to Reject Subscriptions. After we receive your complete, executed subscription agreement and the funds required under the subscription agreement have been transferred to our account, we have the right to review and accept or reject your subscription in whole or in part, for any reason or for no reason. We will return all monies from rejected subscriptions immediately to you, without interest or deduction.

Acceptance of Subscriptions. Upon our acceptance of a subscription agreement, we will countersign the subscription agreement and issue the shares subscribed at closing. Once you submit the subscription agreement and it is accepted, you may not revoke or change your subscription or request your subscription funds. All accepted subscription agreements are irrevocable.

Under Rule 251 of Regulation A, non-accredited, non-natural investors are subject to the investment limitation and may only invest funds which do not exceed 10% of the greater of the purchaser’s revenue or net assets (as of the purchaser’s most recent fiscal year end). A non-accredited, natural person may only invest funds which do not exceed 10% of the greater of the purchaser’s annual income or net worth (please see below on how to calculate your net worth).

NOTE: For the purposes of calculating your net worth, it is defined as the difference between total assets and total liabilities. This calculation must exclude the value of your primary residence and may exclude any indebtedness secured by your primary residence (up to an amount equal to the value of your primary residence). In the case of fiduciary accounts, net worth and/or income suitability requirements may be satisfied by the beneficiary of the account or by the fiduciary, if the fiduciary directly or indirectly provides funds for the purchase of the Offered Shares.

In order to purchase offered Shares and prior to the acceptance of any funds from an investor, an investor will be required to represent, to the Company’s satisfaction, that he is either an accredited investor or is in compliance with the 10% of net worth or annual income limitation on investment in this offering.

No Escrow

The proceeds of this offering will not be placed into an escrow account. We will offer our shares of common stock on a best efforts basis. As there is no minimum offering, upon the approval of any subscription to this Offering Statement, the Company shall immediately deposit said proceeds into the bank account of the Company and may dispose of the proceeds in accordance with the Use of Proceeds.

Selling Stockholders

We are qualifying the resale of shares of Common Stock by the selling stockholders named herein. The selling stockholders, which as used herein includes their permitted transferees, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares on trading facility or quotation service on which such shares are traded or quoted, or in private transactions. These dispositions will be at a set price of $3.00. The offering of the shares by the Company and by the selling stockholders will occur simultaneously.

The selling stockholders may use any one or more of the following methods when disposing of their shares of Common Stock:

The selling stockholders may, from time to time, pledge or grant a security interest in some or all of the shares of Common Stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell their shares, from time to time, under this offering statement, or under an amendment to this offering statement under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this offering statement. The selling stockholders also may transfer their shares in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this offering statement.

In connection with the sale of our Common Stock or interests therein, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of our securities in the course of hedging the positions they assume. The selling stockholders may also sell their securities short and deliver these securities to close out their short positions, or loan or pledge such securities to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of the shares offered by this offering statement, which shares such broker-dealer or other financial institution may resell pursuant to this offering statement (as supplemented or amended to reflect such transaction).

The aggregate proceeds to the selling stockholders from the sale of the shares offered by them will be the purchase price of the share less discounts or commissions, if any. Each of the selling stockholders reserves the right to accept and, together with their agents from time to time, to reject, in whole or in part, any proposed purchase of their shares to be made directly or through agents. We will not receive any of the proceeds from the resale of shares of Common Stock being offered by the selling stockholders named herein.

The selling stockholders also may resell all or a portion of their shares in open market transactions in reliance upon Rule 144 under the Securities Act (“Rule 144”), provided that they meet the criteria and conform to the requirements of that rule.

In connection with an underwritten offering, underwriters or agents may receive compensation in the form of discounts, concessions or commissions from the selling stockholders or from purchasers of the offered shares for whom they may act as agents. In addition, underwriters may sell the shares to or through dealers, and those dealers may receive compensation in the form of discounts, concessions or commissions from the underwriters and/or commissions from the purchasers for whom they may act as agents. The selling stockholders and any underwriters, dealers or agents participating in a distribution of the shares may be deemed to be “underwriters” within the meaning of the Securities Act, and any profit on the sale of the shares by the selling stockholders and any commissions received by broker-dealers may be deemed to be underwriting commissions under the Securities Act.

To the extent required, the shares of Common Stock to be sold, the names of the selling stockholders, the respective purchase prices and public offering prices, the names of any agent, dealer or underwriter, and any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying offering statement supplement or, if appropriate, a post-qualification amendment.

USE OF PROCEEDS

The following table sets forth the uses of proceeds assuming the sale of 100%, 75%, 50%, and 25% of the securities offered for sale by the Company at $3.00 per share. The $3.00 per share price is an arbitrary price per share determined by management. Offering costs are assumed to be $45,000 of fixed costs plus a 10% commission. There is no assurance that we will raise the full amount of the offering.

If 1,333,333 shares (100%) are sold:

Next 12 months

If 1,000,000 shares (75%) are sold:

Next 12 months

If 666.666 shares (50%) are sold:

Next 12 months

If 333,333 shares (25%) are sold:

Next 12 months

The above figures represent only estimated costs for the next 12 months. Because we are in the early stage of our business development and we anticipate that contingencies may arise which are unknown at present, we reserve the right to reallocate the proceeds among the categories as we deem in the best interests of the Company. Any use of the net proceeds for categories other than those set forth above, or in amounts materially in excess of these allocations, will be subject to the approval of the Board of Directors, excluding any director having an interest in the new use or allocation of these funds. Any proceeds from this offering in excess of the actual amounts required for all of these categories will be allocated to the general operating expenses of our Company, or otherwise as determined by the Board.

DESCRIPTION OF BUSINESS

Overview

Global Cancer Technology, Inc. was incorporated under the laws of the State of Nevada on May 18, 2017. It was originally formed as a limited liability company in the State of Texas on January 2, 2013 and converted to its present corporate status on May 18, 2017.

In order to implement the conversion from a Texas limited liability company to a Nevada corporation, the entities entered into a Plan of Conversion, whereby the members of the limited liability company approved the plan and agreed to exchange their membership interests for an aggregate of 351,000 shares of common stock of the corporation on a pro rata basis. We filed articles of conversion in both the states of Texas and Nevada on May 18, 2017.

We have two majority-owned subsidiaries, NanoMed Tracking, Inc., a Nevada corporation formed on July 12, 2017, and MCW Pharmaceuticals Inc., a Montana corporation formed on June 11, 2018. Each subsidiary was established to develop and commercialize a specific technology. NanoMed Tracking was established to commercialize our technology to label and track hospital instruments with Nano Quantum Dots, while MCW Pharmaceuticals was established to commercialize our intellectual property regarding UCN-01. We presently intend to develop each subsidiary’s licensed technology and, if warranted, introduce it to market. We have no current plans or arrangements to sell any subsidiary. We have entered into shareholder agreements with these subsidiaries, the material terms of which are described below:

NanoMed Shareholder Agreement. This agreement, dated June 26, 2017, provides for initial stock ownership of 51% by us until the sale of the entity, if ever, at which point our stock ownership will be reduced to 20% or reduced further upon future funding. The remaining ownership of this subsidiary is owned by members of our Scientific Advisory Board, Milan Makale (9.8%), Wolf Wrasidio (9.8%), and Sadik Esener (9.8%), with the balance owed by a third parties. Each of these persons was instrumental in the development of the technology represented by underlying patent licensed to us and has committed to assist us in pre-clinical work on the technology. They were also instrumental in assisting us in obtaining the license from UCSD. Mr. Clark, our sole officer and director, also serves as a director and CEO of this entity. The agreement includes provisions limiting sale or transfer of the shares and grants the entity certain rights to purchase the shares upon the death or upon the voluntary or involuntary sale or transfer of the stock. The agreement further includes shareholder indemnification provisions and noncompete provisions. The agreement will terminate upon the bankruptcy or dissolution of the Company.

MCW Pharmaceuticals Shareholder Agreement. This agreement, dated May 17, 2018, provides for initial stock ownership of 51% by us until the sale of the entity, if ever, at which point our stock ownership will be reduced to 33.3%. The remaining ownership of the subsidiary is owned by two of the members of our Scientific Advisory Board, Milan Makale (24.5%) and Wolf Wrasidio (24.5%). Each of these persons was instrumental in the development of the technology represented by underlying patent licensed to us and has committed to assist us in pre-clinical work on the technology. They were also instrumental in assisting us in obtaining the license from UCSD. Mr. Clark, our sole officer and director, also serves as a director and CEO of this entity. The agreement includes provisions limiting sale or transfer of the shares and grants the entity certain rights to purchase the shares upon the death or upon the voluntary or involuntary sale or transfer of the stock. The agreement further includes shareholder indemnification provisions and noncompete provisions. The agreement will terminate upon the bankruptcy or dissolution of the Company.

Industry Overview

Medical Instrument Marking

Medical instrument marking, through our subsidiary NanoMed Tracking Inc., puts us in an industry that is relatively new and being driven by an FDA mandate that, “By September 24, 2020, all hospitals in the United States will be required to label each piece of equipment used in surgical operations and in long-term in vivo implantation”¹²³

The Unique Device Identifier (“UDI”) Rule has given birth to several companies with their development of different technologies to mark and track medical instruments. The two basic competing technologies are Radio Frequency Identification (“RFID”) and Laser Engraving. The leading players in this market are Haldor, Censitrac, Microsystems, Surgidat and Key Surgical. These companies all offer varying degrees of the basic technologies found in RFID and Laser Engraving. Major market highlights include:

__________________

¹ Gustafson, K. “Practical Limitations on Quantum Dot-Based Spectral Barcoding.” Undergraduate Senior Design Project Report. Dept. of NanoEngineering, UC San Diego. La Jolla. June 9, 2015.

² Unique Device Identifier (UDI) Rule

3 Amendment to section 502 of Federal Food, Drug, & Cosmetic Act of 1938, specifically to section 226 of the FDA Amendment Act of 2007 and to section 614 of the FDA Safety & Innovation Act of 2012

The growth of the marketplace is very strong with the U.S. market having a compound annual growth rate (“CAGR”) of 8.6% and the global market having a CARG of 9.8%.

Drug Delivery for Pharmacological Drugs

The industry for our two pharmaceutical products (radiosurgical activated nano crystal scintillator with cancer drug + UCN-01) is tied to the drug delivery for pharmacological drugs. The entire drug delivery market (targeted and advanced) is estimated to be worth $319B by the year 2021.The nanotechnology drug delivery market is estimated by the year 2023 to be worth $11.9B. The global nanotechnology drug delivery market has been segmented into nanocrystals, nanoparticles, liposomes, micelles, nanotubes, and others.

The dominant players in this market are Johnson & Johnson, Inc., F. Hoffman – LaRoche, Pfizer, Bayer AG, Novartis AG, 3M Company, Becton, Dickinson and Company, and Glaxo Smith Kline. There are other major players in this field as well.

High Intensity Focused Ultrasound

The industry for our High Intensity Focused Ultrasound is a thriving market with significant growth potential. There are essentially two distinct fragments within this market: MR Guided and Ultrasound – Guided. The key players in this market are: Accutome Inc., Blatek Industries Incorporated, EDAP TMS, Haifu Medical, Koninklijke Philips N.V., Medtronic plc, SonaCare Medical LLC, Stryker, and Insightec. Key applications are in prostate, fibroids and MR guided tumor treatments of the brain. To date, over 150,000 cases have been reported using HIFU technology. The worldwide market for HIFU systems is estimated to be $100MM by 2021 with a with a CAGR 9%.

Description of Business

We have not commercialized any of our products. We have not started any pre-clinical or R&D work on any of our products. We have acquired licenses from universities which permit us to market certain technologies described below. We have organized, or plan to form, three subsidiary entities to bring to market medical technologies in the oncology market represented by these licenses.

NanoMed Tracking, Inc

NanoMed Tracking , Inc is a subsidiary that we have formed to begin commercialization of this unique tracking technology involving nano quantum dots and optical recording. Through our 2016 license obtained from the University of California, San Diego, we intend to develop for market a method to label and track hospital instruments with Nano Quantum Dots. Our system, when developed, is anticipated to consist of an ink-jet polymer coating application device and an optical reader for identifying and tracking disposable object and surgical instruments in surgical operating rooms. The system for identifying and tracking a surgical object comprises a tag identifier including object information encoded on a fluorescent paint coating attached to a surgical object; a detector disposed to receive a reflection of the fluorescent paint from the tag identifier; and a receiver in communication with the detector receiving a single transmitted by the detector wherein the signal is generated by the reflection of the tag identifier. The tag identifier comprises one or more quantum dots arranged to define a spectral signature and a layer coating compromising the one or more quantum dots, wherein the layer coating is attached to an object.

NanoDrug Transport

We intend to create a subsidiary to commercialize our technology using radiosurgery to activate a prodrug attached to a nano Crystal sent the later that has accumulated at a tumor site. For decades, medical radiation specialists have sought to activate by local radiation beams, a non-toxic, interactive version of a cancer drug, (pro-drug) selectively at cancers and not body tissues in general. This strategy is attractive because it aims to overwhelm tumor resistant mechanisms by allowing high drug concentrations at tumor foci, while sparing normal tissue and organs from toxicity, and reducing the generally damaging radiation doses needed to control tumor burden. The technology represented by the license acquired from the University of California, San Diego, introduces a novel concept of linking a prodrug to a nanocrystal radiation scintillator. For example, embodiments are provided herein in which a drug is inactive while linked to the crystal, but in response to radiation the scintillator emits light to break the chemical linker, thereby releasing active drug. Ideally, drug activity focused on areas adjacent to tumors would destroy the micro metastasis that are so challenging to selectively excise or treat. Single cell infiltration that significantly diminishes by a blading the active margin of primary and secondary tumors, especially in early disease stages, would also be desirable. Intravenously injected nanoparticles may concentrate at tumor foci by leaking through typically incomplete tumor vessels, by adhering to tumor micro vessels via well-established targeting ligands and penetrating the blood brain barrier both passively and actively via transferred ligands.

MCW Pharmaceuticals

We have established a subsidiary called MCW Pharmaceuticals Inc. to commercialize our IP regarding UCN-01. Radiotherapy and chemotherapy sensitizing agents based on checkpoint inhibition are an intense area of research and we believe UCN-01 is an excellent candidate. In addition, the ability of UCN-01 to encourage the differentiation of neuronal precursors into neuron has great significance in the arena of recovery from brain injury. UCN-01 is in the public domain but our modified UCN-01 design is proprietary, we believe can be patented on a composition of matter basis, and potentially as a successful drug development candidate. While we have not yet tested this compound, we believe that given the straightforward nature of our approach and the candidate compound that the probability of success is favorable. Our modified UCN-01 would have applicability to all p53 dysregulated tumors and could be transformative in terms of cancer therapy. UCN-01 has been approved for human use in clinical trials and we believe this will aid our FDA approval process.

Boiling Histotripsy

We intend to form a subsidiary called HIFU+. Under the license obtained from the University of Washington, we intend to develop technology using high-intensity focused ultrasound (HIFU) and Histotripsy. HIFU is a non-invasive therapy that uses focused ultrasound waves to thermally ablate a portion of tissue, meaning the tissue is destroyed using intense heat. The intense heat causes tissue coagulation necrosis, cavitation and heat shock in the cells, meaning that the portion of tissue which is being ablated is destroyed. High power ultrasound can be focused on a targeted point to raise the temperature to 70-80°C. HIFU uses sonication (sound energy) to create this heat. Each sonication heats only a small focal target, so the interventional radiologist will use multiple sonications to ablate the whole affected area. The interventional radiologist may use diagnostic sonography with focused ultrasound (USgFUS or USgHIFU) or magnetic resonance guidance with focused ultrasound (MRgFUS).  HIFU is used to treat fibroids, prostate cancer, kidney cancer and primary and secondary liver cancer.

Histotripsy is the capability of therapeutic ultrasound to generate purely mechanical damage of tissue without thermal coagulation. Boiling Histotripsy occurs when the frequency is higher (one – 3 MHz), the pulses are much longer (3000 – 10000 cycles) and delivered less often (0.5 – 1 Hz). The peak pressures are lower, about p-=10-15 MPa and p+>40MPa. In this regime, boiling is initiated within each millisecond – long pulse due to effective tissue heating by shocks

We intend to conduct a one year research and development program with the following two years for pre-clinical and clinical trials in which we will attempt to demonstrate a functional and acoustically characterized preclinical US-guided transrectal BH therapeutic device for ablation of prostate tissue and to obtain FDA approval as a class III medical device.

RGS Orbiter

Under our license with American Radiosurgery, we intend to market the RGS Orbiter, a gamma knife technology used to treat tumors of the brain as well as the rest of the body. The RGS Orbiter requires FDA approval before it can be sold in the U.S. The RGS Orbiter also requires a CE Mark to be sold in most European countries. There are several countries around the world that do not require an FDA approval or a CE Mark. The Company plans to have the manufacturing of the RGS Orbiter completely subcontracted by a third-party entity that will be a turnkey supplier. The FDA approval will be the responsibility of American Radiosurgery, Inc.

Marketing

Each of the license agreements held by us require a long-term commitment to commercialize and bring the products to market. With the exception of the license/distribution agreement with American Radiosurgery Inc., there are no distribution agreements or plans in place at this time for any of these products.

Government Regulation

The FDA plays a vital role and impacts the development of our patents whether it is medical devices such as our High Intensity Focus Ultrasound product and radiosurgery products, or pharmaceutical drug delivery products. We have separated FDA requirements into two categories: the FDA position on drug development and the FDA position on medical device development.

A.        FDA and Drug Development Process 

The company is developing a unique drug transport nanoparticle technology with its nanotechnology scintillator patent and UCN-01 Intellectual Property. Although the company is not developing a drug to bring to market, we must comply with the same FDA regulations, a review of the FDA process for drug development is as follows:

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and implementing regulations. The process of obtaining regulatory approvals and ensuring compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process, or after approval, may subject an applicant to administrative enforcement or judicial sanctions. This enforcement could include, without limitation, the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, untitled or warning letters, corrective actions, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties. 

The process required by the FDA before a drug may be marketed in the United States generally involves the following: 

Once a pharmaceutical product candidate is identified for development, it enters the preclinical testing stage. Preclinical tests include laboratory evaluations of product chemistry, toxicity, formulation and stability, as well as animal studies. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data and any available clinical data or literature, to the FDA as part of the IND. The sponsor must also include a protocol detailing, among other things, the objectives of the initial clinical trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated if the initial clinical trial lends itself to an efficacy evaluation. Some preclinical testing may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA places the clinical trial on a clinical hold within that 30-day time period. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during trials due to safety concerns regarding the product candidate or non-compliance with applicable requirements. 

All clinical trials of a product candidate must be conducted under the supervision of one or more qualified investigators, in accordance with cGCP regulations. These regulations include the requirement that all research subjects provide informed consent. Further, an institutional review board, or IRB, must review and approve the plan for any clinical trial before it commences at any institution. The IRB’s role is to protect the rights and welfare of human subjects involved in clinical studies by evaluating, among other things, the potential risks and benefits to subjects, processes for obtaining informed consent, monitoring of data to ensure subject safety, and provisions to protect the subjects’ privacy. The IRB approves the information regarding the clinical trial and the consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. 

Once an IND is in effect, each new clinical protocol, and any amendments to the protocol, must be submitted to the IND for FDA review and to the IRBs for approval. Protocols detail, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria and the parameters to be used to monitor subject safety. 

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined: 

Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA, and safety reports must be submitted to the FDA and the investigators for serious and unexpected side effects. Phase I, Phase II and Phase III testing may not be completed successfully within any specified period, if at all. Results from earlier trials are not necessarily predictive of results from later trials. The FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients. Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the product and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life. 

FDA Review of New Drug Applications.    The FDA reviews all NDAs submitted to ensure that they are sufficiently complete for substantive review before it accepts them for filing. If the FDA does not find an NDA to be sufficiently complete for filing, it may request additional information rather than accepting the NDA for filing. In this event, the sponsor must resubmit the NDA with the additional information. The re-submitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether clinical data demonstrates that a product is safe and effective for its intended use and whether its manufacturing process can assure the product’s identity, strength, quality and purity. Before approving an NDA, the FDA will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities follow cGMP requirements and adequate to assure consistent production of the product within required specifications. The FDA may refer the NDA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved and under what conditions. An advisory committee is a panel of independent experts who provide advice and recommendations when requested by the FDA. The FDA is not bound by the recommendation of an advisory committee. 

If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages, or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling, and the agency also may require a Risk Evaluation and Mitigation Strategy, or REMS, if it determines that a REMS is necessary to assure that the benefits of a drug outweigh its risks. In addition, the FDA may require Phase IV testing, which involves clinical trials designed to further assess a drug’s safety and effectiveness after NDA approval, and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized. 

Packaging and Labeling

The FDA has mandated that exact packaging and labeling controls shall be in place. Under section 211.122 “Materials examination and usage criteria”:

(a)       there shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials: such written procedures shall be followed. Labeling and packaging materials shall be represented Tivoli samples, and examined or tested upon receipt and before use in packaging or labeling of a drug product.

(b)        Any labeling or packaging materials meeting appropriate written specifications may be approved and released for use. Any labeling or packaging materials that do not meet such specifications shall be rejected to prevent their use in operations for which they are unsuitable

(c)        record shall be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination of testing, and whether accepted or rejected.

(d)        Labels and other labeling materials for each different drug product, strength, and dosage form, or quantity of contents shall be stored separately with suitable identification. Access to the storage area shall be limited to authorized personnel.

(e)        Obsolete and outdated labels, label lien, and other packaging material shall be destroyed.

(f)        use of gang-printed labeling for different drug products, or different strengths or net contents of the same drug product, is prohibited unless the labeling from gang-printed sheets is adequately differentiated by size, shape, or color.

(g)        If cut labeling is used for immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons, packaging and labeling operation shall include one of the following special control procedures:

(1) Dedication of labeling and packaging lines to each different strength of each different drug product:

(2) use of appropriate electronic or electromechanical equipment to conduct a 100% examination for correct labeling during or after completion of finishing operations: or

(3) use of visual inspection to conduct a 100% examination for correct labeling during or after completion of finishing operations for and apply the labeling. Such examination shall be performed by one person and independently verified by a second person.

(4) use of any automated technique, including differentiation by labeling size and shape, that physically prevent incorrect labeling from being processed by labeling and packaging equipment.

(h)        Printing devices on, or associated with, manufacturing lines used to imprint labeling upon the drug product unit label or case shall be monitored to assure that all imprinting conforms to the print specified in the batch production record.

Sec. 211.125 Labeling issuance.

The FDA has implemented strict labeling standards:

(a) Strict control shall be exercised over labeling issued for use in drug product labeling operations.

(b) Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records.

(c) Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found between the quantity of drug product finished and the quantity of labeling issued when such discrepancies are outside narrow preset limits based on historical operating data. Such discrepancies shall be investigated in accordance with 211.192. Labeling reconciliation is waived for cut or roll labeling if a 100-percent examination for correct labeling is performed in accordance with 211.122(g)(2). Labeling reconciliation is also waived for 360deg. wraparound labels on portable cryogenic medical gas containers.

(d) All excess labeling bearing lot or control numbers shall be destroyed.

(e) Returned labeling shall be maintained and stored in a manner to prevent mixups and provide proper identification.

(f) Procedures shall be written describing in sufficient detail the control procedures employed for the issuance of labeling; such written procedures shall be followed. There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products; such written procedures shall be followed. These procedures shall incorporate the following features:

(a) Prevention of mixups and cross-contamination by physical or spatial separation from operations on other drug products.

(b) Identification and handling of filled drug product containers that are set aside and held in unlabeled condition for future labeling operations to preclude mislabeling of individual containers, lots, or portions of lots. Identification need not be applied to each individual container but shall be sufficient to determine name, strength, quantity of contents, and lot or control number of each container.

(c) Identification of the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch.

(d) Examination of packaging and labeling materials for suitability and correctness before packaging operations, and documentation of such examination in the batch production record.

(e) Inspection of the packaging and labeling facilities immediately before use to assure that all drug products have been removed from previous operations. Inspection shall also be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection shall be documented in the batch production records.

Sec. 211.134 Drug product inspection.

The FDA has developed the following inspection standards for drug development:

(a) Packaged and labeled products shall be examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.

(b) A representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for correct labeling.

(c) Results of these examinations shall be recorded in the batch production or control records.

Sec. 211.137 Expiration dating.

The FDA has developed the following regulations for labeling expiration dates:

a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in 211.166.

(b) Expiration dates shall be related to any storage conditions stated on the labeling, as determined by stability studies described in 211.166.

(c) If the drug product is to be reconstituted at the time of dispensing, its labeling shall bear expiration information for both the reconstituted and unreconstituted drug products.

(d) Expiration dates shall appear on labeling in accordance with the requirements of Chapter 201.17.

(e) Homeopathic drug products shall be exempt from the requirements of this section.

(f) Allergenic extracts that are labeled "No U.S. Standard of Potency" are exempt from the requirements of this section.

(g) New drug products for investigational use are exempt from the requirements of this section, provided that they meet appropriate standards or specifications as demonstrated by stability studies during their use in clinical investigations. Where new drug products for investigational use are to be reconstituted at the time of dispensing, their labeling shall bear expiration information for the reconstituted drug product.

(h) Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this section shall not be enforced for human OTC drug products if their labeling does not bear dosage limitations and they are stable for at least 3 years as supported by appropriate stability data.

Post-Approval Requirements and record keeping 

Any drugs receiving FDA approval are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements. 

The FDA strictly regulates marketing, labeling, advertising, and promotion of products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other government agencies enforce the laws and regulations prohibiting the false or misleading promotion of drugs.  Further, manufacturers of drugs must continue to comply with cGMP requirements, which are extensive and require considerable time, resources and ongoing investment to ensure compliance. In addition, changes to the manufacturing process may require prior FDA approval before being implemented, and other types of changes to the approved product, such as adding new indications and additional labeling claims, are subject to further FDA review and approval. Drug manufacturers and other entities involved in the manufacturing and distribution of approved drugs are required to list their products and to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. The cGMP requirements apply to all stages of the manufacturing process, including the production, processing, sterilization, packaging, labeling, storage and shipment of the drug. Manufacturers must establish validated systems to ensure that products meet specifications and regulatory standards and test each product batch or lot prior to its release The FDA may withdraw a product approval if compliance with regulatory standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market. Further, the failure to maintain compliance with regulatory requirements may result in administrative or judicial actions, such as fines, untitled and warning letters, holds on clinical trials, product recalls or seizures, product detention or refusal to permit the import or export of products, refusal to approve pending applications or supplements, restrictions on marketing or manufacturing, consent decrees, injunctions or the imposition of civil or criminal penalties. 

From time to time, legislation is drafted, introduced and passed in the U.S. Congress that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products regulated by the FDA. In addition to new legislation, the FDA regulations and policies are often revised or reinterpreted by the agency in ways that may significantly affect our business and our product candidates. It is impossible to predict whether further legislative or FDA regulation or policy changes will be enacted or implemented and what the impact of such changes, if any, may be. 

FDA and the U.S. Food & Drug Administration: Enforcement and Sanctions

The Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act or the Act) promotes public health by preventing fraudulent activity with respect to food, drugs, and an array of other public health products that enter interstate commerce. Indeed, the Act’s primary purpose is to “safeguard” and “protect” consumers from exposure to dangerous products affecting public health and safety. The FD&C Act does this by regulating covered articles from their introduction into interstate commerce to their delivery to the ultimate consumer.

The FD&C Act is the main federal law regulating the safety of most foods, food additives, color additives, dietary supplements, prescription and non-prescription drugs, medical devices, cosmetics, and tobacco products. While the Act regulates a host of disparate products, it generally prohibits two basic acts: “adulteration” and “misbranding.” Specifically, the FD&C Act makes it illegal to distribute directly or indirectly a covered product in interstate commerce that is adulterated or misbranded and defines the terms “adulteration” and “misbranding” with respect to specific products.

The FD&C Act is chiefly enforced by the U.S. Food and Drug Administration (FDA), an agency whose general mission is to promote and protect the public health by ensuring the safety, efficacy, and truthful labeling of the products it regulates. FDA enforces the Act through administrative mechanisms, such as pre-market reviews of certain products, examinations and investigations, and dissemination of information to the public. While primarily focused on interstate commerce, FDA’s authority extends to intrastate activities that have a nexus with interstate commerce and concern a product that the Act covers. Supreme Court precedent recognizes that FDA enjoys significant discretion over enforcement of most FD&C Act provisions. Because FDA, like most executive agencies, does not have independent litigating authority, it must coordinate with the Department of Justice (DOJ) to pursue criminal or civil remedies. In addition to DOJ, other federal agencies play a role in enforcing discrete parts of the Act; private parties, however, do not have rights to enforce the FD&C Act through lawsuits.

For serious FD&C Act violations, the FDA, in coordination with DOJ, has a wide range of civil and criminal remedies. For example, the FD&C Act authorizes the government to sue violators of the Act in court in order to punish or prevent future violations. Such civil actions include imposing money penalties, injunctions, and seizures. Other enforcement actions include warning letters, import alerts, recalls, and debarments. For extremely serious violations, FDA and DOJ may collaborate to bring criminal charges. A criminal violation of the FD&C Act does not require that the perpetrator have a “guilty mind.” Intentional or repeated violations of the Act may result in multiple years of imprisonment and significant criminal fines.

The DEA regulates controlled substances under the Controlled Substances Act of 1970. We do not believe any of our products would be subject to this act. 

FDA Import, Export and Foreign Regulation

The FDA states that all FDA-regulated products imported into the United States are required to meet the same laws and regulations as domestic goods. Imported foods must be pure, wholesome, safe to eat and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe for their intended use and properly labeled; radiation-emitting devices must meet established standards; tobacco products must meet U.S. requirements, and all products must contain informative and truthful labeling in English. FDA-regulated products are subject to inspection when offered for import into the United States. Products may be refused entry if they appear, from examination or otherwise, to violate FDA requirements. Some products are subject to certification and/or testing requirements due to a past history of violations; these are identified in import alerts and in certain international cooperative arrangements. In addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our product candidates to the extent we choose to clinically evaluate or sell any products outside of the United States. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence marketing of the product in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country. As in the United States, post-approval regulatory requirements, such as those regarding product manufacture, marketing or distribution, would apply to any product that is approved outside the United States. 

Third Party Payor Coverage and Reimbursement

In both the United States and foreign markets, our ability to commercialize our product candidates successfully, and to attract commercialization partners for our product candidates, depends in significant part on the availability of adequate financial coverage and reimbursement from third party payors, including, in the United States, governmental payors such as the Medicare and Medicaid programs, managed care organizations, and private health insurers. Medicare is a federally funded program managed by the Centers for Medicare and Medicaid Services, or CMS, through local Medicare Administrative Contractors that administer coverage and reimbursement for certain healthcare items and services furnished to the elderly and disabled. Medicaid is an insurance program for certain categories of patients whose income and assets fall below state defined levels and who are otherwise uninsured that is both federally and state funded and managed by each state. The federal government sets general guidelines for Medicaid and each state creates specific regulations that govern its individual program. Each government or private payor has its own process and standards for determining whether it will cover and reimburse a procedure or product and how much it will pay for that procedure or product. Private payors often rely on the lead of the governmental payors in rendering coverage and reimbursement determinations. Therefore, achieving favorable CMS coverage and reimbursement is usually a significant gating issue for successful introduction of a new product. The competitive position of some of our products will depend, in part, upon the extent of coverage and adequate reimbursement for such products and for the procedures in which such products are used. Prices at which we or our customers seek reimbursement for our product candidates can be subject to challenge, reduction or denial by the government and other payors. We beleive that our products, once available for sale, will be reimbursed by government and private agencies.

Summary of Our Pharmaceutical Patent and IP facing FDA Issues

We have two technologies that we believe would be subject to the above referenced FDA regulations. Our “prodrug attached to a nanoCrystal scintillator” patent and our UCN-01 intellectual property (“products”) will likely fall under the FDA’s drug development process.

The timeframe and projected costs for the process should be the same for each technology:

We have not commenced pre-clinical or clinical trials on either of our products. We are currently not impacted by any FDA regulation as we have not commenced commercialization of our products.

B.        FDA and Medical Device Development Process

We are developing a new medical device involving High Intensity Focused Ultrasound (“HIFU”) which we believe will be classified as a medical device. The Federal Food, Drug, and Cosmetic Act (FD&C Act) presents a detailed definition of “device.” Put succinctly, the term refers to “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory” that is 1) recognized in the National Formulary or the US Pharmacopoeia, 2) intended to help diagnose, cure, ease, treat, or prevent a disease or condition, or 3) intended to affect bodily function or structure—but not by metabolism or chemical action within or on the body. The term applies to a broad range of healthcare-related items. As explained in the FDA’s 2006 information sheet guidance Frequently Asked Questions about Medical Devices, that list includes surgical lasers, wheelchairs, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. It also extends to tampons, catheters, and breast implants, and to epidural needles, cardiopulmonary blood pumps, cochlear implants, and implantable prostheses, as noted in another of the FDA’s guidance’s, Significant Risk and Nonsignificant Risk Medical Device Studies. The rules regulating a particular device depend on whether the FDA classifies it as Class I, II, or III. The FDA classifies medical devices based on their intended uses and the level of risk that use poses. Title 21 of the Code of Federal Regulations Part 860 (21 CFR Part 860) contains the provisions pertaining to medical device classification:

Class I devices pose the least risk and are subject only to the baseline, “general controls” authorized under the FD&C Act, including regulations pertaining to adulteration (section 501), misbranding (section 502), device registration (section 510), banned devices (section 516), and records/reports (section 519). Class I includes not only items as simple as elastic bandages, crutches, and thermometers, but also skull plate anvils, which are used for skull reconstruction, and the battery-powered artificial larynx.

General controls apply to each class of medical devices, but many devices require additional measures to ensure safety and effectiveness. When general controls alone are deemed insufficient to guarantee a device’s safety and effectiveness, but there is enough information to establish “special” controls, the FDA places it in Class II. Special controls can include performance standards, post-market surveillance, patient registries, guidance documents, and other recommendations. Examples of Class II devices include tests for sickle cell disease, stationary and mobile x-ray systems, and pneumatic surgical drills. Condoms, air handlers for surgical operating rooms, oxygenators used during cardiopulmonary bypass surgery, and dura substitute (material used to repair the membrane surrounding the brain) are also Class II devices.

Class III devices pose the highest degree of risk. Devices in Class III are used to support or sustain life, or their use “is of substantial importance” to prevent impairment to health or poses “potential unreasonable risk of illness or injury.” To ensure safety and effectiveness, such devices require premarket approval (see below) by the FDA; that is, general and special controls alone are not enough to guarantee safety and efficacy. Devices in Class III include cranial electrotherapy stimulators, replacement heart valves, suctioning devices and tongs used to remove foreign objects from a patient’s airway, intrauterine devices (IUDs) for contraception, and soft contact lenses intended for extended wear. It is a manufacturer’s responsibility to determine a device’s classification. The FDA maintains a product classification database, and 21 CFR Parts 862-892 lists 1,700 types of devices, organized by medical specialty into 19 “panels,” such as “Clinical chemistry and clinical toxicology devices” (part 862), “Gastroenterology-urology devices” (part 876), and “Radiology devices” (part 892). Entries at 21 CFR Parts 862-892 include a description of each device type, its intended use, and its class. We believe that the HIFU product will most likely be classified as a class III device requiring FDA approval for a class III medical device.

Under section 513(g) of the FD&C Act, manufacturers may submit a 513(g) Request for Information to petition the FDA for information about the regulatory requirements for a particular device and its classification. The FD&C Act gives the FDA 60 days to respond in writing to a request; the agency has said it intends to keep to the prescribed timetable.

Device clearance and approval processes

Because of the potential risks they pose, Class III devices face rigorous scientific and regulatory review via the premarket approval (PMA) pathway. Section 515 of the FD&C Act describes the PMA pathway, while regulations governing the process are outlined in 21 CFR Part 814. PMA applications require “many volumes of material,” according to the FDA, including a description of the device and its intended use, the results of both non-clinical and clinical studies, case reports, a description of the manufacturing process, proposed product labeling, and so forth. Following a review of the application, if the FDA determines there is enough scientific evidence to provide reasonable assurance that the device can be used safely and effectively for its intended purpose(s), the agency approves the device for marketing. Class III devices that do not meet PMA requirements are not approved and may not be marketed; the FDA deems them “adulterated” under section 501(f) of the FD&C Act.

As noted, the FDA has determined that the risks associated with Class I and Class II devices can be managed via either general controls or general and special controls combined. Most Class I and II devices require premarket notification via the 510(k) pathway. Less rigorous than the PMA pathway, the 510(k) process is intended to demonstrate that a device is “substantially equivalent” to an existing device—called the predicate device—that is legally marketed for the same indication. Substantial equivalence refers to a product’s safety and efficacy vis à vis its predicate. As explained by the FDA, 2 devices are substantially equivalent when:

As explained in 21 CFR Part 807.81, the FDA requires a 510(k) submission when a device is introduced to the market for the first time, when a change or modification to a marketed device could “significantly affect” its safety or effectiveness, and when there is a “major” change or modification to the intended use of a marketed device.

Following the FDA’s review of a 510(k) submission, the agency may take any of the following actions:

If the FDA declares that a product is not substantially equivalent to an established device, the applicant may not legally market the device. The applicant may:

De novo classification orders

A sponsor filing a de novo petition is asking the FDA to perform a risk-based evaluation to gain Class I or II status for a device. Under the Food and Drug Administration Modernization Act of 1997 (FDAMA), sponsors of low- to moderate-risk novel devices may request de novo classification after receiving a “not substantially equivalent” decision to a 510(k) submission. Sponsors may also take the “direct de novo” pathway, requesting de novo classification without submitting a 510(k) at all. The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) introduced the “direct de novo” option. Novel devices cannot be considered “substantially equivalent” to predicate devices—they do not have predicates. As explained in the FDA’s De Novo Classification Process (Evaluation of Automatic Class III Designation), “devices of a new type that FDA has not previously classified” are automatically considered Class III devices, “regardless of the level of risk they pose or the ability of general and special controls to assure safety and effectiveness.” Not having a predicate does not automatically mean a device is high risk, however. If there are data to support that a novel device poses only low to moderate risk, the sponsor can apply for de novo classification that, if granted, spares them the lengthy PMA process. A de novo petition must include a description of the novel device and reasons for the recommended classification; the FDA has 120 days to make a determination. If the FDA grants the de novo request, the device is assigned to either Class I or Class II, establishing a new device “type” that may be marketed immediately and used as a predicate for future premarket notification 510(k) submissions. The FDA announces the new classification regulation in the Federal Register, specifying any relevant special controls (for Class II devices). If the FDA declines a de novo request, the device remains Class III and may not be marketed without a PMA or a product development protocol filing. We do not anticipate submitting a de novo classification request.

Quality System (QS) Regulation 21 CFR Part 820

The quality system specifies the regulatory requirements related to the methods, facilities, and controls used for the entire medical device lifecycle, including the purchasing, designing, manufacturing, packaging & labeling, storing, installing and servicing of the devices. The FDA mandates to establish and follow quality system requirements for manufacturers to ensure that the devices meet applicable requirements and specifications consistently. The FDA quality system is as current good manufacturing practices (CGMPs) and forced under part 820 (21 CFR part 820), authorized by section 520 (F) and became effective on December 18, 1978

Labeling Requirements – 21 CFR Part 801

It is mandatory to apply labels on each device. Labeling contains labels and literature in the form of description and information that accompanies the device usage. This regulation specifies the requirements in the below form:

The Federal Food, Drug and Cosmetic Act (FFDCA) is the law under which the FDA acts against regulated products. Specifically, section 201(k) defines “label” as a:

Section 201(m) defines “labeling” as:

Under § 812.5 an investigational device or its immediate package must bear a label with the following information:

The label must also describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions. The labeling of an investigational device must not contain any false or misleading statements nor imply that the device is safe or effective for the purposes being investigated.

If the investigational device is used solely for research on laboratory animals, the label must contain the following statement: "CAUTION Device for investigational use in laboratory animals or other tests that do not involve human subjects." The sponsor should provide detailed information on device labeling in the investigational plan. This information may vary depending on the device and the nature of the study. Product labeling should be sufficient to ensure stability of the test article for the duration of the study (storage requirements, calibration procedures), bear sufficient directions for proper administration, and detail procedures to follow in the event of patient injury.

Medical Device Reporting (MDR) – 21 CFR Part 803

The Medical Device Reporting (MDR) regulation ( 21 CFR 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. The regulation specified that reports be filed on FDA Medwatch Form 3500A or an electronic equivalent. The FDA published a final rule on Feb. 14, 2014, requiring manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. This rule will be effective as of Aug.14, 2015. In several cases where a medical device causes a death or a serious injury or in case of certain device malfunction, it is required to report FDA for the same. The goal of this regulation is to timely detect and correct problems by identifying and monitoring significant negative effects of a particular medical device. Here are the reporting rules to be followed by manufacturers, importers and medical facility owners:

International Registration

In order to sell our products in member countries of the EEA our products must comply with the essential requirements of the EU Medical Devices Directive (Council Directive 93/42/EEC). Compliance with these requirements is a prerequisite to be able to affix the CE Mark to our products, without which they cannot be sold or marketed in the EEA. To demonstrate compliance with the essential requirements we must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the essential requirements of the EU Medical Devices Directive, a conformity assessment procedure requires the intervention of an organization accredited by a Member State of the EEA to conduct conformity assessments, or a Notified Body. Depending on the relevant conformity assessment procedure, the Notified Body would typically audit and examine the technical file and the quality system for the manufacture, design and final inspection of our devices. The Notified Body issues a certificate of conformity following successful completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the essential requirements. This certificate entitles the manufacturer to affix the CE Mark to its medical devices after having prepared and signed a related EC Declaration of Conformity.  As a rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence. Upon receipt of FDA approval for the HIFU device, the company will immediately file for a CE mark and undergo that process.

Summary of our Medical Device Patents Facing FDA Issues

Our medical device patent is a High Intensity Focused Ultrasound Device (HIFU) that is under R&D development at the University of Washington in Seattle Washington. It utilizes an entirely new and unique approach which incorporates ‘Boiling Histotripsey’. The U.S. Food and Drug Administration (FDA) has automatically classified focused ultrasound (FUS) devices Class III, which requires sponsors to demonstrate the safety and effectiveness of a device through clinical trials. This requirement adds significant time and cost to the device development process; reclassification to Class II would be highly beneficial for the future of HIFU. The company intends to file a PMA for a class III registration and pursue this pathway to FDA approval. Currently the company is doing preliminary and traditional R& D studies at the University of Washington to perfect the concept. The R&D that needs to be complete before submitting a PMA is as follows:

(i) Design, fabricate, and characterize ultrasound probes for transrectal BH studies. We would simulate nonlinear HIFU fields generated by transrectal probes with different geometries to design a transducer capable of operating in shock-forming conditions relevant to Benign Hyperthophy, or BH.

(ii) Refine BH treatment strategies in ex vivo prostatic tissue. Based on the acoustic characterization results and the derating approach developed by our team for predicting in situ parameters of nonlinear ultrasound field, we would design BH treatment protocols and test them in phantom gels mimicking prostate and ex vivo canine prostate tissue. be used in the in vivo experiments. Mechanically ablated volumes in ex vivo canine prostate tissue would be evaluated grossly and processed for histology.

(iii)Assess feasibility and tolerability of transrectal BH treatment in vivo in clinically relevant canine models of prostate disease. Feasibility, safety, and tolerability of the transrectal BH treatment would be performed first in healthy canine prostate (acute).

Timeline for Clinical Preparation:

After this one year period, we intend to begin the FDA registration for a class III device, which we believe will require an additional two years to complete the FDA approval process.

Total Cost of Clinical Preparation and Deliverable Machine:

We estimate that the research costs would include the following:

At this point of our development, we have completed contracts with University of Washington to develop this technology. There are no preclinical or clinical studies underway currently. We intend to initiate these activities upon successful funding.

With respect to our RGS technology, this is a distribution and licensing agreement. Our company is not the manufacturer of the equipment and all FDA registrations and permits are the responsibility of the manufacturer. The RGS Vertex 360 is currently FDA approved by American Radiosurgery, Inc. and the RGS Orbiter should be submitted for FDA approval under a 510 K program that we believe would be relatively straightforward, and this should occur sometime within the next six months.

SUMMARY OF FDA DRUG AND DEVICE PATHWAYS.

Drug and device approval pathways share common characteristics. Each has special pre-submission opportunities for collaboration with the FDA. Each has three main pathways to approval. For each there is a main pathway requiring significant clinical evidence of efficacy and safety (the Investigational New Drug Application and the PMA, respectively), and a pathway for emergency use (the emergency investigational new drug and the Emergency Use notification, respectively). Deciding which path to initiate is only the first of a series of challenges that face the investigator. Early and regular communication with the FDA is encouraged to avoid pitfalls and problems that may waste time and resources.

Competition

The markets in which we intend to operate are highly competitive and generally highly regulated. Competition is intense in each of our proposed business segments and includes many large and small competitors. Brand, design, quality, safety, ease of use, serviceability, price, product features, warranty, delivery, service, and technical support are important competitive factors to us. We expect to face continued competition in the future as new Nano and other medical products and services enter the market. We believe many organizations are working with a variety of Nano technologies.

The license agreement with American Radiosurgery covering the RGS Orbiter and its development represents the closest to market product that we have. The RGS Orbiter has one major competitor, a Swedish company named Elekta, which manufactures the Gamma knife. An additional smaller competitor is a Chinese company called MASEP, and they produce a gamma-based system that only treats head tumors. We intend to be innovative in creating strategic partnerships with leading medical institutions to establish an RGS Orbiter site.

We believe that in all our business segments our long-term competitive position depends on our success in discovering, developing, and marketing innovative, cost-effective products and services. We devote significant resources to acquiring technology developed at leading universities and one research and development efforts, and we believe we are positioned as a global competitor in the search for technological innovations.

There can be no assurance that we will develop significant products or services, or that the products or services we provide or develop will be more commercially successful than those provided or developed by our competitors. In addition, some of our existing or potential competitors may have greater resources than we have. Therefore, a competitor may succeed in developing and commercializing products more rapidly than we do.

Research and Development

The Company has spent approximately $100,000 in the past two years for research and development purposes and product development. These costs were borne solely by the Company.

Intellectual Property

Nano-Quantum Dot License

Effective October 13, 2016, we entered an exclusive world-wide License Agreement with University of California, San Diego (“UCSD”) for products created under U.S. Patent 9,019,078 issued on April 28, 2015, relating to technology to track hospital instruments using an applied nano-Quantum Dot polymer (nQD) and an optical scanner system. Specifically, the patent covers a method and apparatus for identifying and tracking surgical objects such as needles, scalpels, blades, sponges and instruments in the medical industry using an identifier encoded on a fluorescent paint attached to the object combined with detectors and software capable of retrieving the identifying information on the identifier. The license also grants us the right to grant sublicenses.

We are required to make certain payments to UCSD to maintain the license. In 2017 we paid a license issue fee of $12,500 and are required to pay license maintenance fees of $5,000 in year one of the agreement, $7,500 in year two, and $10,000 in year three and annually thereafter. We are also obligated to pay an earned royalty of 2.5% of net sales of licensed products by us or our sublicensees, or 20% of sublicense fees received that are not earned royalties. We are also obligated to make certain minimum annual royalty payments beginning the calendar year of commercial sales of the first licensed product, which has not occurred, and which will be offset by earned royalty payments. Further, we have agreed to reimburse UCSD for $20,000 of past patent costs which are due 30 days following an equity financing by us of at least $250,000, and all future patent costs. Late payments will incur interest charges of 10%.

We have agreed to diligently develop, manufacture, and sell the licensed products, and have further agreed to accomplish certain tasks or milestones related to the technology. If we fail to perform these tasks, USCD may either terminate the agreement or change the license to a non-exclusive one. We have further agreed to obtain all necessary government approvals for the manufacture, use, and sale of the licensed products and to fill market demand for them.

UCSD may terminate the license agreement generally if we are delinquent in any reports or payments, if we do not diligently develop and commercialize the licensed product, if we breach any provision of the agreement, subject to our right to cure any default within 60 days after receiving notice of default. We may terminate the agreement for any reason upon 90 days’ written notice. The term of the license agreement expires on the date of the longest-lived patent right granted under the license.

We have agreed to indemnify UCSD, its officers, employees, and agents, and to cause any sublicensee to provide indemnification, against any claim or other action resulting from our exercise of the license or any sublicense. We have further agreed to maintain commercial and product liability insurance for activities in connection with the work under the agreement. We intend to obtain insurance upon commencement of work under the agreement.

Nano-Crystal Scintillator License

Effective November 18, 2016, we entered an exclusive world-wide License Agreement with University of California, San Diego (“UCSD”) for products created under U.S. Patent Application serial number 15/052,526 relating to technology to attach an inactive prodrug to a nano-crystal scintillator that is radiosurgically activated at the tumor site releasing the prodrugs energy. The license also grants us the right to grant sublicenses.

We are required to make certain payments to UCSD to maintain the license. In 2017 we paid a license issue fee of $10,000 and are required to pay license maintenance fees of $5,000 in year one of the agreement, $7,500 in year two, and $10,000 in year three and annually thereafter. We are also obligated to pay an earned royalty of 2.5% of net sales of licensed products by us or our sublicensees, or 20% of sublicense fees received that are not earned royalties. We are also obligated to make certain minimum annual royalty payments beginning the calendar year of commercial sales of the first licensed product, which has not occurred, and which will be offset by earned royalty payments. Further, we have agreed to reimburse UCSD for $21,500 of past patent costs which are due 30 days following an equity financing by us of at least $250,000, and all future patent costs. Late payments will incur interest charges of 10%.

We have agreed to diligently develop, manufacture, and sell the licensed products, and have further agreed to accomplish certain tasks or milestones related to the technology. If we fail to perform these tasks, USCD may either terminate the agreement or change the license to a non-exclusive one. We have further agreed to obtain all necessary government approvals for the manufacture, use, and sale of the licensed products and to fill market demand for them.

UCSD may terminate the license agreement generally if we are delinquent in any reports or payments, if we do not diligently develop and commercialize the licensed product, if we breach any provision of the agreement, subject to our right to cure any default within 60 days after receiving notice of default. We may terminate the agreement for any reason upon 90 days’ written notice. The term of the license agreement expires on the date of the longest-lived patent right granted under the license.

We have agreed to indemnify UCSD, its officers, employees, and agents, and to cause any sublicensee to provide indemnification, against any claim or other action resulting from our exercise of the license or any sublicense. We have further agreed to maintain commercial and product liability insurance for activities in connection with the work under the agreement. We intend to obtain an insurance policy

Boiling Histotripsy License

Effective March 8, 2018, we entered into an exclusive world-wide Start-up License Agreement with the University of Washington under certain patents licensed by the university and a non-exclusive world-wide license for certain know-how for the development and commercialization of a new form of High Intensity Focused Ultrasound called ‘Boiling Histotripsy’. We also have the right to grant sublicenses for the licensed technology. Because the inventions covered by the licensed patents arose in whole or in part from federally supported research, the federal government has certain statutory rights to the technology. We have agreed to use our commercially reasonable efforts to commercialize the licensed rights and are obligated within 30 days after each calendar year-end to submit reports describing these efforts. The provisional and non-provisional patents under which the license were filed or issued between 2010 and 2016.

Under the License Agreement we have agreed to meet certain milestones consisting of the following obligations:

We have agreed to pay a running royalty fee of 3.5% on net sales of licensed products, to be credited against minimum annual fees commencing the year of first commercial sale or March 8, 2020, whichever is sooner. We are also required to pay a non-creditable license fee of $250,000 prior to March 8, 2019, unless we create a startup company based on the licensed products, in which case the fee would be waived in exchange for the university receiving equity in the startup company equal to 5% of the outstanding shares on a fully-diluted basis through the time the equity offering of $250,000 is completed. We have also agreed to pay 50% of any sublicense consideration received and a percentage of funds received upon the sale or the company, determined by the number of milestones met. Further, we have agreed to pay to or reimburse the university for its expenses related to the patents.

We may terminate the agreement at any time, or the License Agreement will terminate when all licensed rights have terminated or if we breach any of our material duties under the agreement.

American Radiosurgery Distributorship Agreement

On October 1, 2017, we entered into an exclusive worldwide Technology License Agreement with American Radiosurgery, Inc. (“ARI”) to market and service products developed by ARI, including the Rotating Gamma System Vertex360 (currently FDA approved) and the RGS Orbiter, a Cobalt-60 gamma-based radiosurgery device for treatment of small and midsized lesions of the total body of the patient, including the brain. Under the terms of the agreement, we receive a commission on sales of the devices and are obligated to sell at least one device per year. Since commencement of the agreement, we have not sold any devices. We are also required to provide all warranty work for existing devices sold by ARI and devices sold by us. There are six devices currently installed which are covered by warranty. We are also permitted to provide removal services for existing devices throughout the world. The agreement may be terminated ARI upon 30 days’ prior notice by ARI if we fail to meet our selling quotas, or by either party for breach of the agreement or without cause.

Trademarks

The Company, at this point, has no trademarks and no immediate plans to apply for any trademarks.

Employees

Except for our CEO who devotes his full-time to the business of the Company, we have no other employees.

Office Space

The Company has a mailing address at 16776 Bernardo Center Court Suite 203 San Diego, CA 92128. The Company has no offices or facilities leased or owned at this time.

DESCRIPTION OF PROPERTY

The Company has a mailing address at 16776 Bernardo Center Court Suite 203 San Diego, CA 92128. The Company has no offices or facilities leased or owned at this time.

MANAGEMENT’S DISCUSSION AND ANALYSIS

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our annual and interim financial statements included elsewhere in this offering circular. In addition to historical data, this discussion contains forward-looking statements about our business, operations and financial performance based on current expectations that involve risks, uncertainties and assumptions. Actual results may differ materially from those discussed in the forward-looking statements as a result of various factors. Factors that could or do contribute to these differences include those factors discussed below and elsewhere in this offering circular, particularly under the captions “Risk Factors” and “Forward-Looking Statements.”

Background

We are in the startup phase of our development and have acquired various licenses for the development of innovative technologies in the areas of Nano drug transport, UCN-01, surgical instrument tracking, and a new form of High Intensity Focused Ultrasound. We also have a distribution license with an affiliated company which has developed a gamma-based radiosurgery device for treatment of tumors of the brain as well as the rest of the body. Our business plan is to develop and bring these new technologies to market and to continue the testing and marketing of the radiosurgery device.

From November 2017 through July 2018 we borrowed $202,500 from investors and issued promissory notes in this aggregate amount. Each note bears interest at 7% per annum and matures one year from issuance. We are not permitted to prepay these notes prior to maturity without the consent of the note holders. If we undertake a self-registered IPO prior to maturity, these notes are convertible at the rate of $0.25 to $0.50 per share, or the same terms as the IPO, whichever are more favorable to the note holder. These notes also provide for piggyback registration rights. The borrowed funds were used for general and administrative purposes. The funds were also used to support the accounting and legal costs of the qualification process.

Plan of Operation

We have five unique and distinct technologies under our control.

Nano Quantum Dots and Optical Recording License

We hold a license agreement from UCSD for utilizing nano quantum dots and optical recording to mark and track materials. Our first launch of this technology will be in marking medical instruments with a polymer containing nano quantum dots that we have licensed to our subsidiary, NanoMed Tracking, Inc., to develop and commercialize the product. Our plan of operation for this technology is as follows:

Quantum Dot/Polymer Marker

The beta for this technology has been completed and validated. In the beta process we were able to internally demonstrate and visualize quantum dots that we mixed into a polymer marker substance. Upon illuminance, the quantum dots were easily readable in the polymer solution. We internally validated the findings by confirming and recording the sequence of quantum dots that we illuminated. This technology is planned to be developed and finalized within one year of successful funding from our offering. We will then have a polymer formulation blended with quantum dots that emit a unique fluorescent spectral signature when exposed to a source of light. We plan on internally completing the quantum dot code validation and optimization in the same year with funds raised from this offering. We anticipate successful reliability testing, autocalving and sterilization to also occur within that same year at no additional outlay of expenditures.

Optical Reader

The beta for this technology has been completed and validated. In the beta testing process, we were able to internally visualize and record the quantum dots in the polymer solution We will read the Qdot/Polymer Marker through the use of an amplifier-digitizer configured to filter the spectral signature and digitized the signal into a readable format. Size reduction is currently underway, and we anticipate hi-pass through scanning to be achieved within one year of and the funding needed for these steps will come from funds raised from the offering.

The next steps in order to develop the technology are as follows:

Go to Market Strategy

Our strategy to bringing the technology to market is as follows:

We intend to develop fully both the Quantum Dot/Polymer Marker and the Optical Reader within one year of completion of this offering. At that point, we believe the product would be ready to market. To achieve the above steps in our go to market strategy we will require additional funding. Our projections estimate approximately $3 million in additional funding for successful implementation and scaling of our operations. We plan to seek an additional $3 million through financing provided by institutional partners or venture capitalists, although we currently have no arrangements or agreements for the additional funding.

Attachment of Cancer Drug to a Nano Crystal Scintillator License

We hold a license from UCSD that allows for the attachment of a cancer drug to a nano crystal scintillator, which keeps the cancer drug inactive until it accumulates at the tumor. At the tumor site, the drug is remotely activated using radiosurgery, allowing 100% of the energy of the drug to be available in the tumor. We are the only company in the world working on this novel drug transport approach. Our plan of operation for this technology is as follows:

After these parameters are identified and satisfactory results achieved, we will then go to clinical trials and make all the appropriate applications. The clinical trials will replicate all the testing that has been done in the preclinical trials. It is estimated that the preclinical trials will take approximately one year to finish and that the clinical studies will take approximately three years to finish. We have identified potential partners to assist us in the preclinical phase of this drug transport technology, although we have not entered into any specific arrangements or binding agreements. WE believe most clinical trials will utilize the scientists from UCSD to conduct initial preclinical studies in combination with local private corporations. We have not begun any preclinical studies at this point. Management believes up to $1 million in excess of the funds from this offering will be required to complete the above validations.

Go to Market Strategy

We are actively seeking a strategic partner for initiating our preclinical studies. We are currently in negotiations to enter into an agreement with Imagion Biosystems, a San Diego company who is a leader in the use of nano crystal scintillators and iron oxide particles for a new and advanced imaging technique. If successful, we believe this would create the first nano crystal scintillator carrying the ability to image a tumor and simultaneously treat the tumor with the therapeutic agent. If completed, this partnership with Imagion Biosystems could produce a large part of preclinical data that we could integrate with other strategic partners we are developing for the preclinical work. The exact cost of these activities is undetermined, but we believe proceeds from this offering would cover expenses incurred. Once preclinical testing is accomplished, we would then proceed to the clinical phase trial. This period could take up to two years and cost approximately $3 million. Following this offering, we plan to implement traditional equity or debt funding methods to proceed with clinical trials. It is anticipated that the $3 million necessary for clinical trials would be raised through a financing provided by institutional partners or venture capitalists, although we currently have no commitment for this funding. If we obtain FDA acceptance and approval, we would need to raise additional funds for full marketing implementation, which we estimate could require an additional $5 million or more. We intend to seek a corporate partnership to secure the funding.

Small Molecule and Nanoparticle-Based Radiation Chemotherapy Sensitizers for Solid Tumor Therapy

We hold a license from UCSD for a small molecule and nanoparticle based radiation and chemotherapy sensitizers for solid tumor therapy. UCN-01 is a 7-hydroxy staurosporine that has been in 22 NIH sponsored clinical trials. UCN-01 failed translation because of poor pharmacokinetics and tumor entry caused by binding to AAG human plasma protein. Our approach calls for a unique way to modify UCN-01 as a radiation sensitizer. We will follow the same steps to commercialization with preclinical and clinical studies as we will with our nanocrystal scintillator cancer drug protocol. Both preclinical and clinical studies will confirm:

We have allocated $500,000 from our use of proceeds to meet the financing requirements for the above preclinical studies.

Other considerations are given to the following in both of our pharma projects:

We intend to perform much of the preclinical work on UCN-01 simultaneously with preclinical work stemming from studies in the attachment of a prodrug to a nano Crystal scintillator. We believe this combination preclinical testing could save the company approximately $500,000 in expenses.

To begin the commercialization of the UCN-01, we have incorporated a new subsidiary called MCW Pharmaceuticals. We intend to transfer all patent and IP rights into this new company. We also intend to seek a strategic partner to assist us in bringing the technology to market. Following this offering, we intend to seek an additional $3 million in funding to perform clinical trials on the scintillator. We intend to seek additional funding for this testing and ultimately propose to seek a corporate partner for a full marketing program if FDA approval is achieved.

High Intensity Focus Ultrasound

We hold a license from the University of Washington for 16 different patents involving a new form of high intensity focus ultrasound (“HIFU”). This breakthrough technology is called “Boiling Histotripsy” (“BH”). We intend to commercialize the product primarily for use in prostate disease and then develop the technology for other cancer treatments.

There are three goals to be achieved in the preclinical phase which are:

At the end of our preclinical period we will have demonstrated:

We intend to use funds from this offering for the project and are working towards acquiring a strategic partner for development following preclinical trials.

RGS Orbiter

We have a distribution and licensing agreement for technology related to the treatment of brain tumors and additional tumors outside of the body with a gamma-based device known as the RGS Orbiter. We seek to develop and finalize the placement of systems in the U.S. under an agreement with American Radiosurgery, Inc. We are pursuing a marketing program to install the first system in the U.S. under a partnership agreement with a leading hospital. No such agreement has been signed at this time but several partnership opportunities seem promising. The development cycle that has been completed to date is as follows:

We have several international placements in development but no single installation has been finalized to date. We have allocated $500,000 from proceeds of this offering for the RGS Orbiter development. We believe this amount will be sufficient to bring the RGS Orbiter to market. The technical designs of the RGS Orbiter have been completed and data has been prepared for an FDA submission. We anticipate a 510K approval in approximately four to six months after submission to the FDA, which would permit us to commence accepting orders. The Company believes that it has a foothold and recognized name in the radiosurgery market as a result of placing several previous versions of the RGS Orbiter. We believe this presence will aid and assist our initial marketing efforts.

Results of Operations

The following discussion compares the results for the six-month period ended June 30, 2018 to the six -month period ended June 30 , 2017, and the results for the year ended December 31, 2017 to the year ended December 31, 2016.

Six Months Ended June 30, 2018 Compared to the Six Months Ended June 30, 2017

During the six months ended June 30, 2018 and 2017, the Company had no operating revenues in its primary field of endeavor although it was able broker medical equipment sales of $25,000 in 2017 which resulted in gross profit of $15,000. During the six months ended June 30, 2018, the Company incurred operating expenses of $181,341 consisting primarily of R&D expenses, consulting fees and travel expenses and other general and administrative costs and interest cost of $4,215. During the six months ended June 30, 2017, the Company incurred operating expenses of $214,031. These operating expenses combined with the small gross profits from sales resulted in net losses of $(185,556) and $(199,031) for the six-month periods ended June 30, 2018 and 2017, respectively. As of June 30, 2018, the Company had stockholders' deficit of $(289,406) compared to a stockholders' deficit of $(122,438) as of June 30, 2017.

Year Ended December 31, 2017 Compared to the Year Ended December 31, 2016

During the years ended December 31, 2017 and 2016, the Company had no operating revenues in its primary field of endeavor although it was able broker medical equipment sales of $25,000 and $78,690 in those years, respectively which resulted in gross profit of $15,000 and $25,520, respectively. During the year ended December 31, 2017, the Company incurred operating expenses of $388,791 consisting primarily of R&D expenses, consulting fees and travel expenses and other general and administrative costs and interest cost of $427. During the year ended December 31, 2016, the Company incurred operating expenses of $165,853. These operating expenses combined with the small gross profits from sales resulted in net losses of $(374,218) and $(140,333) for the periods ended December 31, 2017 and 2016, respectively. As of December 31, 2017, the Company had stockholders' deficit of $(214,550) compared to a stockholders' deficit of $(62,407) as of December 31, 2016. The decrease in stockholders' deficit was due to the net loss of $(374,218) for 2017 offset by the additional issuance of $219,075 of common stock, comprised of $77,500 for cash and $144,575 for services.

Liquidity and Capital Resources

We have incurred losses since inception of our business and, as of June 30, 2018, we had an accumulated deficit of $888,681. As of June 30, 2018, we had cash of $32,223 and a negative working capital of $290,354.

To date, we have funded our operations through sales outside of our primary fields of endeavor, short-term debt and equity financing. During the year ended December 31, 2017 through July 2018, the Company received $202,500 of borrowed funds in the form of convertible debt from non-related parties. In addition, during the year ended December 31, 2017 through July 2018, the Company issued the following common stock: 402,400 shares for cash proceeds and 624,800 shares for services.

We expect our expenses will continue to increase during the foreseeable future as a result of increased operational expenses and the development of our products under license. However, we do not expect to start generating revenues from our operations for another 12 months. Consequently, we are dependent on the proceeds from future debt or equity investments to sustain our operations and implement our business plan. If we are unable to raise sufficient capital, we will be required to delay or forego some portion of our business plan, which would have a material adverse effect on our anticipated results from operations and financial condition. There is no assurance that we will be able to obtain necessary amounts of additional capital or that our estimates of our capital requirements will prove to be accurate. As of the date of this Offering Statement we did not have any commitments from any source to provide such additional capital. Even if we are able to secure outside financing, it may not be available in the amounts or the times that we require. Furthermore, such financing would likely take the form of bank loans, private placement of debt or equity securities or some combination of these. The issuance of additional equity securities would dilute the stock ownership of current investors while incurring loans, leases or debt would increase our capital requirements and possible loss of valuable assets if such obligations were not repaid in accordance with their terms.

Off-Balance Sheet Arrangements

Since our inception, we have not engaged in any off-balance sheet arrangements.

Significant Accounting Policies

This summary of significant accounting policies of GCT is presented to assist in understanding the Company's financial statements. The financial statements and notes are representations of the Company's management, which is responsible for their integrity and objectivity. These accounting policies conform to accounting principles generally accepted in the United States and have been consistently applied in the preparation of the financial statements.

Basis of Presentation

The accompanying financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America ("US GAAP") and include the accounts of the Company and its subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.

Cash and Cash Equivalents

Cash and cash equivalents consist of deposits in one large national bank. At December 31, 2017 and 2016 respectively, the Company had $34,850 and $2,204 in cash. The Company has not experienced any losses in such accounts and believes it is not exposed to any risks on its cash in bank accounts.

Use of Estimates

The preparation of financial statements in accordance with generally accepted accounting principles requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities known to exist as of the date the financial statements are published, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates and assumptions and could have a material effect on the reported amounts of the Company's financial position and results of operations.

Property and Equipment

Property and equipment is stated at cost and depreciated using the straight-line method over the estimated useful life of the asset. Equipment at December 31, 2017 consisted of computer equipment.

Fair Value of Financial Instruments

The Company's financial instruments as defined by ASC 825-10-50, include cash, receivables, accounts payable and accrued expenses. All instruments are accounted for on a historical cost basis, which, due to the short-term maturity of these financial instruments, approximates fair value at December 31, 2017 (and 2016).

Earnings (Losses) Per Share

Basic net loss per share was computed by dividing the net loss by the weighted average number of shares outstanding during the year. The weighted average number of shares was calculated by taking the number of shares outstanding and weighting them by the amount of time they were outstanding. Weighted average of number of diluted securities was the same as weighted average of basic securities because the effect of dilutive securities was non-dilutive.

Provision for Taxes

Income taxes are provided based upon the liability method of accounting pursuant to ASC 740-10-25 Income Taxes — Recognition. Under the approach, deferred income taxes are recorded to reflect the tax consequences in future years of differences between the tax basis of assets and liabilities and their financial reporting amounts at each year-end. A valuation allowance is recorded against deferred tax assets if management does not believe the Company has met the "more likely than not" standard imposed by ASC 740-10-25-5 to allow recognition of such an asset.

New Accounting Pronouncements

The Company has evaluated the authoritative guidance issued during the year ended December 31, 2017 and does not expect the adoption of these standards to have a material effect on its financial position or results of operations.

DIRECTORS AND EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Current Management

The following table sets forth as of November 7, 2018, the name and age of, and positions held by, our sole executive officer and director and his employment background:

Term of Office

We are permitted to have not less than one or more than 15 directors, as determined by resolution of the Board of Directors. Directors are elected at the annual meeting of the stockholders and hold office until their successor is elected and qualified. Directors need not be stockholders. As a shareholder owning a majority of the issued and outstanding voting shares of the Company, Mr. Clark has the right to set the number of directors and elect each direct to service on the Board.

No Involvement in Certain Legal Proceedings

Our sole director and executive officer has not, during the past ten years:

Scientific Advisory Board

Central to Global Cancer Technology, Inc.’s strategic direction is the identification and development of proprietary products and platform technologies to better meet identified clinical demand. The Scientific Advisory Group plays a key role in meeting this objective. The charter for this Group is to work with our company to identify and advise on new proprietary devices and consider technologies with broad clinical applications. The following individuals serve at the Company’s discretion on such board:

Dr. Santosh Kesari. Dr. Santosh Kesari is a world-renowned board-certified neurologist and neuro-oncologist and is currently Chair, Department of Translational Neuro-Oncology and Neurotherapeutics, John Wayne Cancer Institute. He is also Director of Neuro-Oncology, Providence Saint John’s Health Center and Member, Los Angeles Biomedical Research Institute. Dr. Kesari is ranked among the top 1% of neuro-oncologists and neurologists in the nation, according to Castle Connolly Medical Ltd and an internationally recognized scientist and clinician. He is a winner of an Innovation Award by the San Diego Business Journal. He is on the advisory board of American Brain Tumor Association, San Diego Brain Tumor Foundation, Chris Elliott Fund, Nicolas Conor Institute, Voices Against Brain Cancer, and Philippine Brain Tumor Alliance. He has been the author of over 250 scientific publications, reviews, or books. He is the inventor on several patents and patent applications, and founder and advisor to many cancer and neurosciences focused biotech start-ups. Dr. Kesari graduated from University of Pennsylvania, School of Arts and Sciences in 1992 and earned a Ph.D. degree in molecular biology and a M.D. from the University of Pennsylvania, School of Medicine. He completed his residency in neurology at the Massachusetts General Hospital/Brigham and Women’s Hospital/Harvard Medical School and his neuro-oncology fellowship at the Dana-Farber Cancer Institute in Boston. He was previously assistant professor of neurology at Harvard Medical School/Dana-Farber Cancer Institute/Brigham and Women’s Hospital and then professor of neurosciences at UC San Diego.

Sadik Esener, PhD. Applied Physics and Electrical Engineering from UCSD Professor of Nanoengineering and Electrical and Computer Engineering at UC San Diego. Internationally known expert in photonics, opto-electronics, and cancer nanotechnology. Sadik served as director of major research centers including NCI funded NanoTumor Center at UCSD. Specializes in cancer nanotechnology, in vivo imaging, optical systems and their interface with electronics and software. Sadik has been closely involved with 12startup companies as co-founder including Genoptix, Nanogen, OriMedix, Devacell, and Ziva. Authored more than 350 publications.

Wolf Wrasidlo, PhD. Organic Chemistry from San Diego State University & University of Erlangen. Highly experienced polymer and organic chemist. Head of the Chemical Biology Program at the Moores Cancer Center at the UC San Diego School of Medicine and a Research Scientist in the Department of Neuroscience. Held senior level positions at The Scripps Research Institute, Humboldt University Berlin Medical School, University of Tuebingen Childrens' Hospital, and Columbia University. Distinguished Research Fellow at TargeGen, a Founder and the Head of Research at Brunswick Biotechnetics, a Research Scientist at General Atomics, and a member of the Member- Macromolecular Chemistry Group at the Boeing Scientific Research Institute.and founder of Neuropore.

Milan Makale, PhD. Radiation Biology at the University of Alberta. Biomedical engineer, faculty member at UC San Diego Moores Cancer Center. Specializes in medical devices and imaging, worked in academia and development stage pharmaceutical companies. A U.S. National Research Council Associate at the U.S. DoD. MS in Biomedical Engineering, at George Washington University, and worked in functional and structural neuroimaging research at NINDS, NIH Bethesda, MD. Co-founded Engineered Medical Devices Inc., Lemma Pharmaceuticals. Member of the American Chemical Society, the Society for Neuro-Oncology, and the Whittaker Institute of Bioengineering.

Dr. Ted Dubinsky. Dr. Ted Dubinsky serves as the Lawrence A. Mack Endowed Professor of Radiology, Obstetrics and Gynecology, University of Washington School of Medicine and as the Editor in Chief of Ultrasound Quarterly.  Dr. Dubinsky is a well-published and highly recognized luminary in the field of High Intensity Focused Ultrasound, having authored over 100 published peer review papers. At the University of Washington, Dr. Dubinsky served as the Director of Body Imaging an Adjunct Associate Professor of Obstetrics and Gynecology. Dr. Dubinsky achieved his medical degree from the University of Maryland after graduating from Johns Hopkins University

Dr. Aizik Wolf. Dr. Wolf is a world-renowned radiosurgery neurosurgeon who has performed more private practice brain cancer treatments with gamma knife radiosurgery than any other neurosurgeon in the world. A member of numerous professional organizations, including the American Medical Association, American Association of Neurological surgeons, and the International Brain Research Organization, Dr. Wolf is also a founding member of the International Radiosurgery Support Association.   Dr. Wolf has been the recipient of numerous grants and research awards.  He has acted as principal investigator for two clinical trials involving treatment for severe head injury, both of which were funded by the National Institutes of Health.  Also, the American College of Surgeons presented Dr. Wolf and his investigative team with a Research Award for an abstract detailing a lobectomy procedure. Widely published, Dr. Wolf has authored and co-authored numerous book chapters and journal articles on neurological surgery, including work published in Advances in Neurology and the Journal of Neurosurgery.  He has presented his research as an honoured speaker and invited lecturer at many medical meeting and conferences around the world, such as the Annual Meeting of the American Association of Neurological Surgeons, the Society for Neuroscience and the International Stereotactic Radiosurgery Society. Dr. Wolf graduated summa cum laude from Yale Medical School and trained at the University of Minnesota Hospitals. Earlier in his career, Dr. Wolf served as chief of epilepsy and skull-base surgery at the University of Maryland and assistant professor of neurology and neurosurgery. He received his Gamma Knife training at Brown University. Dr. Wolf founded the Miami Neuroscience Center in 1993. Over the past two decades, he and his team have performed nearly 7,000 Gamma Knife surgeries, acquiring a level of expertise unmatched in the field. The team's long-time collaboration also led to a number of medical breakthroughs. The team was the first to make extensive use of radiosurgery to manage multiple metastases. It was also one of the first to apply radiosurgery to treat large-sized benign tumors, and the first nationally to provide Gamma Knife treatments on an outpatient basis.

Dr. Maheep Gaur. In 1996 Dr. Gaur joined fellowship program in Stereotactic Functional Neurosurgery and Radiosurgery at Stereotaxis and Gamma Knife Centre, Fujieda Heisei Memorial Hospital, Shizuoka, Japan, under Dr. Tatsuo Hirai and Dr. Takaaki Takizawa. During this fellowship he participated in about 500 Gamma Knife Surgeries and Micro-recording assisted functional neurosurgery procedures for movement disorders. He learned various aspects of stereotactic frame based and frameless neuro navigation. On return to India in 1997 he joined Vidyasagar Institute of Mental Health and Neuro Sciences [Vimhans] at New Delhi India as Consultant Neurosurgeon. In 1998 he established first Gamma Knife centre in a dedicated neuroscience centre in SAARC region. He was designated head of Gamma knife Surgery at Vimhans. He has experience of more than 2000 Gamma Knife Treatments collectively. He is the founder of the Asian Radiosurgery Conference and conducted the first Asian Gamma Knife Training Program at Saitama Japan.

Endre Takacs, Ph.D. Dr. Takacs serves as an Associate Professor, Department Physics and Astronomy, Clemson University. He was an Associate Professor at the University of Debrecen Medical and Health Science Center. While there, he was instrumental in developing the EXPLORER 4Dâ treatment planning system, which is the core operating technology for the family of Rotating Gamma Systems. Dr. Takacs received his Doctorate in Atomic Physics at The University of Debrecen and completed a post Doctorial program in Plasma Radiation from the NIST in Gaithersburg Maryland.

Prof. Dr. Laszlo Bognar. Prof. Bognar graduated from the Semmelweis University in 1982 and then obtained a specialist qualification in neurology and neurosurgery in 1986 and 1989, respectively. As of 2005, he has been director of the Clinic of Neurosurgery at the Center of Medical and Health Sciences of Debrecen University, Associate professor, as of 2006, professor. Apart from leading the clinic, he is an external consultant in child neurosurgery at the Institute. His key area of specialization is the research and treatment of brain tumors. He is greatly experienced in the surgical treatment of cerebralspinal fluid (CSF) circulation disorders, In epileptic surgery and in the operative treatment of cranial deformities. Professor Bognar founded the Rotating Gamma Institute – Debrecen and place the first Rotating Gamma System (RGS) in Eastern Europe. Professor Bognár lectures around the world on stereotactic radiosurgery.

Everett C. Burdette, Ph.D. Dr. Burdette is President and CEO of Acoustic MedSystems, Inc., a company developing image guided interventions for brachytherapy and localized therapies using high intensity ultrasound. He serves on the corporate boards of Provena Health Systems Central Illinois Region, Oncology Systems, Inc. and Acoustic MedSystems Inc. Previously he was vice president of research and clinical design at computerized medical systems (CMS) and president of the image guidance division of CMS. He was president and chief executive officer of Burdett Medical Systems from its inception in 1997 until its acquisition by Advanced Technology Development for Donier Medical Systems, Inc., a Daimler –Benz company, 1992 – 97. He was president of Labthermics Technologies capping, a medical therapeutic equipment company from 1986 to 1992. He was a faculty member at the University of Illinois at Urbana – Champaign, Emery University school of Medicine, and Georgia Tech. He has worked in the radiation oncology, hyperthermic oncology, ultrasound imaging, and urological feels for 27 years and prior to that worked in the development of radar systems in microwave devices for military applications for seven years. He has managed the development of ultrasound and electromagnetic medical devices for therapeutic and diagnostic applications for 25 years. He has authored more than 170 technical reports and scientific publications and seven book chapters and holds 34 patents.

Committees of the Board

Our Company currently does not have nominating, compensation or audit committees or committees performing similar functions nor does our Company have a written nominating, compensation or audit committee charter. Our Directors believe that it is not necessary to have such committees, at this time, because the Board of Directors can adequately perform the functions of such committees.

Our Company does not have any defined policy or procedural requirements for shareholders to submit recommendations or nominations for Directors. The Board of Directors believes that, given the stage of our development, a specific nominating policy would be premature and of little assistance until our business operations develop to a more advanced level. Our Company does not currently have any specific or minimum criteria for the election of nominees to the Board of Directors and we do not have any specific process or procedure for evaluating such nominees. The Board of Directors will assess all candidates, whether submitted by management or shareholders, and make recommendations for election or appointment.

A shareholder who wishes to communicate with our Board of Directors may do so by directing a written request addressed to our CEO and Director, at the address appearing on the first page of this filing.

Independence of Directors

Our securities are not listed on a national securities exchange or in an inter-dealer quotation system which has requirements that directors be independent. As a result, we have adopted the independence standards of the NYSE MKT LLC to determine the independence of our directors and any directors serving on a committee. These standards provide that a person will be considered an independent director if he or she is not an officer of the company and is, in the view of the company’s board of directors, free of any relationship that would interfere with the exercise of independent judgment. Our board of directors has determined that our sole director, Mr. Clark, would meet this standard, and therefore, all would be considered not to be independent.

EXECUTIVE COMPENSATION

The following table sets forth the compensation of the named executive officer for each of the two fiscal years ended December 31, 2017 and 2016:

Summary Compensation Table

From January 2013 through April 30, 2018 we compensated Mr. Clark with a yearly salary of $75,000, but we had no formal employment agreement with him. As of December 31, 2017 and 2016, the balance of accrued and unpaid compensation for Mr. Clark was $101,224 and $43,242, respectively. On May 1, 2018, we entered into a full-time five-year employment agreement with Mr. Clark to serve as our chief executive officer. This agreement is automatically extended for additional one-year terms unless terminated at least 90 days prior to the expiration of any term. Under the terms of the agreement we have agreed to pay him a base salary of $100,000 per year. In addition, we issued him 100,000 shares of common stock as a signing bonus. He is also eligible to receive an annual bonus of a minimum of 50% and a maximum of 400% upon achievement of performance objectives, none of which have yet been determined. He is also entitled to participate in employee benefits available to other senior executives and 12 weeks paid vacation per year.

The employment agreement is terminable upon the death or disability of Mr. Clark, and for cause. We have agreed to provide a disability policy equal to at least two-thirds of the highest monthly salary. If we otherwise terminate the employment contract, we have agreed to pay Mr. Clark a severance benefit equal to three times his largest base salary if termination occurs prior to December 31, 2020, and four times the largest base salary if the termination occurs after that date.

We have further agreed to indemnify Mr. Clark in the event of certain legal actions by reason of his service as a director, officer, or employee of our company or for his service at our request as a director, officer, member, employee or agent of another company. We have also agreed to advance to Mr. Clark the costs of any such actions provided that he provides us with an undertaking to repay the amounts if it is ever determined that he was not entitled to such costs advances.

Outstanding Equity Awards at Fiscal Year-End

No equity awards were granted to or held by the above-named executive officer during the years ended December 31, 2017 or 2016.

Director Compensation

We did not compensate any directors during the year ended December 31, 2017, and we have not adopted a policy to compensate directors in the future. Our bylaws permit us to pay director’s expenses of attendance at each meeting of the Board of Directors and a fixed sum for attendance at each meeting of the Board of Directors or a stated salary as director. Receiving compensation as a director does not preclude that party from serving in any other capacity and receiving compensation therefor. Members of special or standing committees may also be allowed like reimbursement and compensation for attending committee meetings.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

The following table sets forth certain information furnished by current management and others, concerning the ownership of our common stock as of November 7, 2018, of (i) each person who is known to us to be the beneficial owner of more than 5 percent of our common stock, without regard to any limitations on conversion or exercise of convertible securities or warrants; (ii) all directors and executive officers; and (iii) our directors and executive officers as a group:

INTEREST OF MANAGEMENT AND OTHERS IN CERTAIN TRANSACTIONS

On May 18, 2017, in connection with the conversion of our Texas limited liability company into our Nevada corporation we issued 9,800,000 shares to John Clark, our sole officer and director, and our principal shareholder, in return for his interest in the Texas company. Mr. Clark received his interest in the limited liability company for services performed as founder of the company.

On October 1, 2017, we entered into an exclusive distributorship agreement with American Radiosurgery, Inc., an entity controlled by Mr. Clark. Under the terms of the agreement, we have not made any payments to American Radiosurgery since commencement of the agreement.

DESCRIPTION OF SECURITIES

Common Stock

We are authorized to issue up to 100,000,000 shares of $.001 par value common stock. The holders of common stock, including the shares offered hereby, are entitled to equal dividends and distributions, per share, with respect to the common stock when, as and if declared by the Board of Directors from funds legally available therefore. No holder of any shares of common stock has a pre-emptive right to subscribe for any securities of our company nor are any common shares subject to redemption or convertible into other securities of our company. Upon liquidation, dissolution or winding up of our company, and after payment of creditors and preferred stockholders, if any, the assets will be divided pro-rata on a share-for-share basis among the holders of the shares of common stock.

Each share of common stock is entitled to one vote with respect to the election of any director or any other matter upon which shareholders are required or permitted to vote. Under Nevada corporate law, holders of our company’s common stock do not have cumulative voting rights, so that the holders of more than 50% of the combined shares voting for the election of directors may elect all of the directors, if they choose to do so and, in that event, the holders of the remaining shares will not be able to elect any members to our board of directors.

Status as a Pseudo California Corporation

Section 2115 of the California General Corporation Law subjects certain foreign corporations doing business in California to various substantive provisions of the California General Corporation Law in the event that the average of its property, payroll and sales is more than 50% in California and more than one-half of its outstanding voting securities are held of record by persons residing in the State of California. Currently, we believe our Company meets this test and would be considered a pseudo California corporation, even though it was incorporated under the laws of the State of Nevada. Our designation as a pseudo California corporation would continue until the end of the first year following a year in which we did not meet one of these tests.

Some of the substantive provisions applicable to a pseudo California corporation include laws relating to the annual election of directors; the removal of directors without cause; the removal of directors by court proceedings; the filling of director vacancies where less than a majority in office were elected by shareholders; directors' standard of care; the liability of directors for unlawful distributions; indemnification of directors, officers and others; limitations on corporate distributions; the liability of shareholders who receive unlawful distributions; annual shareholders' meetings and remedies if such meetings are not timely held; supermajority vote requirements; limitations on the sale of assets; limitations on mergers; board and shareholder approvals required in reorganizations; dissenters' rights; records and reports; special jurisdiction of the state attorney general if certain shareholder protective provisions are not being complied with; and shareholders' and directors' rights of inspection. Section 2115 would also subject us to Section 708 of the California General Corporation Law which mandates that shareholders have the right of cumulative voting at the election of directors.

We believe our business is currently being conducted in compliance with all of these applicable laws.

Penny Stock

The Securities Exchange Commission 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 quoted on the NASDAQ system, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock, to deliver a standardized risk disclosure document prepared by the Commission, that: (a) contains a description of the nature and level of risk in the market for penny stocks in both public offerings and secondary trading;(b) contains a description of the broker's or dealer's duties to the customer and of the rights and remedies available to the customer with respect to a violation to such duties or other requirements of Securities' laws; (c) contains a brief, clear, narrative description of a dealer market, including bid and ask prices for penny stocks and the significance of the spread between the bid and ask price;(d) contains a toll-free telephone number for inquiries on disciplinary actions;(e) defines significant terms in the disclosure document or in the conduct of trading in penny stocks; and;(f) contains such other information and is in such form, including language, type, size and format, as the Commission shall require by rule or regulation.

The broker-dealer also must provide, prior to effecting any transaction in a penny stock, the customer with; (a) bid and offer quotations for the penny stock;(b) the compensation of the broker-dealer and its salesperson in the transaction;(c) the number of shares to which such bid and ask prices apply, or other comparable information relating to the depth and liquidity of the market for such stock; and (d) a monthly account statements showing the market value of each penny stock held in the customer's account.

In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from those rules; the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser's written acknowledgment of the receipt of a risk disclosure statement, a written agreement to transactions involving penny stocks, and 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 stock if it becomes subject to these penny stock rules. Therefore, because our common stock is subject to the penny stock rules, stockholders may have difficulty selling those securities.

Holders of Our Common Stock

As of September 5, 2018, we had 71 holders of record of our common stock.

Dividends

There are no restrictions in our articles of incorporation or bylaws that prevent us from declaring dividends. Nevada law, however, does prohibit us from declaring dividends where after giving effect to the distribution of the dividend we would not be able to pay our debts as they become due.

We have not declared any dividends and we do not plan to declare any dividends in the foreseeable future.

Securities Authorized for Issuance under Equity Compensation Plans

On May 1, 2018, our board of directors adopted the 2018 Stock Incentive Plan (the “Plan”) which was subsequently approved by a majority of the outstanding votes of our shareholders. The purposes of the Plan are (a) to enhance our ability to attract and retain the services of qualified employees, officers, directors, consultants, and other service providers upon whose judgment, initiative and efforts the successful conduct and development of our business largely depends, and (b) to provide additional incentives to such persons or entities to devote their utmost effort and skill to the advancement and betterment of our company, by providing them an opportunity to participate in the ownership of our Company and thereby have an interest in the success and increased value of our Company.

There are 500,000 shares of common stock authorized for non-qualified and incentive stock options, restricted stock units, restricted stock grants, and stock appreciation rights under the Plan, which are subject to adjustment in the event of stock splits, stock dividends, and other situations.

The Plan is administered by our board of directors; however, the board of directors may designation administration of the Plan to a committee consisting of at least two independent directors. Only employees of our Company or of an “Affiliated Company”, as defined in the Plan, (including members of the board of directors if they are employees of our Company or of an Affiliated Company) are eligible to receive incentive stock options under the Plan. Employees of our Company or of an Affiliated Company, members of the board of directors (whether or not employed by our company or an Affiliated Company), and “Service Providers”, as defined in the Plan, are eligible to receive non-qualified options, restricted stock units, and stock appreciation rights under the Plan. All awards are subject to Section 162(m) of the Internal Revenue Code.

No option awards may be exercisable more than ten years after the date it is granted. In the event of termination of employment for cause, the options terminate on the date of employment is terminated. In the event of termination of employment for disability or death, the optionee or administrator of optionee’s estate or transferee has six months following the date of termination to exercise options received at the time of disability or death. In the event of termination for any other reason other than for cause, disability or death, the optionee has 30 days to exercise his or her options.

The Plan will continue in effect until all of the stock available for grant or issuance has been acquired through exercise of options or grants of shares, or until ten years after its adoption, whichever is earlier. Awards under the Plan may also be accelerated in the event of certain corporate transactions such as a merger or consolidation or the sale, transfer or other disposition of all or substantially all of our assets.

Under the terms of the Employment Agreement with Mr. Clark, on May 1, 2018, the Board granted 100,000 shares to Mr. Clark as a restricted stock award.

SELLING SHAREHOLDERS

The shares being offered for resale by the selling stockholders consist of 499,200 shares of our common stock held by 24 shareholders.

The following table sets forth the name of the selling stockholders, the number of shares of common stock beneficially owned by each of the selling stockholders as of September 5, 2018 and the number of shares of common stock being offered by the selling stockholders. The shares being offered hereby are being qualified to permit public secondary trading, and the selling stockholders may offer all or part of the shares for resale from time to time. However, the selling stockholders are under no obligation to sell all or any portion of such shares nor are the selling stockholders obligated to sell any shares immediately upon qualification of this offering circular. All information with respect to share ownership has been furnished by the selling stockholders.

* Less than 1%

The number and percentage of shares beneficially owned is determined in accordance with Rule 13d-3 of the Exchange Act, and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rule, beneficial ownership includes any shares as to which the selling stockholders has sole or shared voting power or investment power and also any shares, which the selling stockholders has the right to acquire within 60 days.

INTERESTS OF NAMED EXPERTS AND COUNSEL

Our financial statements for the years ended December 31, 2017 and 2016, appearing in this Offering Statement have been audited by Ankit Consulting Inc., and are included in reliance upon such reports given upon the authority of Ankit Consulting Inc., as experts in accounting and auditing.

The validity of the shares of common stock offered under this Offering Statement is being passed upon for us by Pearson, Butler & Carson, PLLC, Attorneys at Law, South Jordan, Utah.

LEGAL PROCEEDINGS

From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. However, litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. We are currently not aware of any such legal proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or operating results.

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

UNAUDITED AND UNREVIEWED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE 6-MONTH PERIODS ENDED JUNE 30, 2018 AND 2017

FOR THE PERIODS ENDED DECEMBER 31, 2017 AND 2016

Global Cancer Technology, Inc.

Consolidated Balance Sheets (Unaudited and Unreviewed)

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

Global Cancer Technology, Inc.

Consolidated Statement of Operations (Unaudited and Unreviewed)

For the Six Months Ended June 30, 2018 and 2017

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

Global Cancer Technology, Inc.

Consolidated Statement of Stockholders' Deficit (Unaudited and Unreviewed)

For the Six Months ended June 30, 2018

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

Global Cancer Technology, Inc.

Consolidated Statement of Cash Flows (Unaudited and Unreviewed)

For the Six Months Ended June 30, 2018 and 2017 

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

Global Cancer Technology, Inc.

Notes to Consolidated Unaudited and Unreviewed Financial Statements

For the Six Months Ended June 30, 2018

NOTE 1 - ORGANIZATION AND DESCRIPTION OF BUSINESS

Global Cancer Technology, Inc. (GCT or The Company) was incorporated under the laws of the State of Nevada on May 18, 2017. It was originally formed as a limited liability company in the State of Texas on January 2, 2013 and converted to its present corporate status on May 18, 2017.

On July 12, 2017 the Company filed Articles of Incorporation in the State of Nevada for a subsidiary called NanoMed Tracking Inc. (NanoMed). GCT is a 51% owner of NanoMed and the minority owners are scientists integral to the development of the licensed products.

On June 11, 2018 the Company filed Articles of Incorporation in the State of Montana for a subsidiary called MCW Pharmaceuticals Inc.(MCW). The Company intends to transfer into this subsidiary a license obtained from UCSD. GCT is a 51% owner of MCW and the minority owners are scientists integral to the develop of the licensed products.

Business Overview

GCT has no products or services which we provide, except in connection with our license agreement with American Radiosurgery described below. We have acquired licenses from universities which permit us to market certain technologies.

GCT was formed to acquire a portfolio of various medical licenses for unique and promising patents and intellectual properties. The company has acquired licenses from the University of California, San Diego - John Moores Cancer Center and from the University of Washington. In addition, GCTholds an exclusive technology license from American Radiosurgery, Inc., an affiliated entity, to promote and sell high technology radiosurgery and cancer treatment products.

GCT is a startup stage company and has not yet achieved meaningful operating status.

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES

This summary of significant accounting policies of GCT is presented to assist in understanding the Company's financial statements. The financial statements and notes are representations of the Company's management, which is responsible for their integrity and objectivity. These accounting policies conform to accounting principles generally accepted in the United States and have been consistently applied in the preparation of the financial statements.

Basis of Presentation

The accompanying financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America ("US GAAP") and include the accounts of the Company and its subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.

Cash and Cash Equivalents

Cash and cash equivalents consist of deposits in one large national bank. At June 30, 2018 and 2017, the Company had $32,223 and $2,940 in cash, respectively. The Company has not experienced any losses in such accounts and believes it is not exposed to any risks on its cash in bank accounts.

Use of Estimates

The preparation of financial statements in accordance with generally accepted accounting principles requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities known to exist as of the date the financial statements are published, and the reported amounts of revenues and expenses during the reporting period. Uncertainties with respect to such estimates and assumptions are inherent in the preparation of the Company's financial statements; accordingly, it is possible that the actual results could differ from these estimates and assumptions and could have a material effect on the reported amounts of the Company's financial position and results of operations.

Property & Equipment

Property and equipment is stated at cost and depreciated using the straight-line method over the estimated useful life of the asset. Equipment at June 30,2018 consisted of computer equipment.

Fair Value of Financial Instruments

The Company's financial instruments as defined by ASC 825-10-50, include cash, receivables, accounts payable and accrued expenses. All instruments are accounted for on a historical cost basis, which, due to the short-term maturity of these financial instruments, approximates fair value at June 30, 2018 and 2017.

Earnings (Losses) Per Share

Basic net loss per share was computed by dividing the net loss by the weighted average number of shares outstanding during the year. The weighted average number of shares was calculated by taking the number of shares outstanding and weighting them by the amount of time they were outstanding. Weighted average of number of diluted securities was the same as weighted average of basic securities because the effect of dilutive securities was non-dilutive.

Provision for Taxes

Income taxes are provided based upon the liability method of accounting pursuant to ASC 740-10-25 Income Taxes — Recognition. Under the approach, deferred income taxes are recorded to reflect the tax consequences in future years of differences between the tax basis of assets and liabilities and their financial reporting amounts at each year-end. A valuation allowance is recorded against deferred tax assets if management does not believe the Company has met the "more likely than not" standard imposed by ASC 740-10-25-5 to allow recognition of such an asset.

New Accounting Pronouncements

The Company has evaluated the authoritative guidance issued during the six-month period ended June 30, 2018 and does not expect the adoption of these standards to have a material effect on its financial position or results of operations.

Note 3 - Going Concern

The accompanying financial statements have been prepared on a going concern basis, which assumes the Company will be able to realize its assets and settle its liabilities in the ordinary course of business. In the foreseeable future.

As shown in the accompanying financial statements, the Company has incurred operating losses since inception. As of June 30, 2018, the Company has limited financial resources with which to achieve its objectives and obtain profitability and positive cash flows. As shown in the accompanying balance sheets and statements of operations, as of June 30, 2018 the Company has an Accumulated Deficit $888,681 and a working capital deficit of $286,239. Achievement of the Company's objectives will be dependent upon the ability to obtain additional financing, and generate revenue from current and planned business operations, and control costs. The Company is in the development stage and has generated no operating income.

The Company plans to fund its future operations by joint venturing or obtaining additional financing from investors and/or lenders. However, there is no assurance that the Company will be able to achieve these objectives, therefore substantial doubt about its ability to continue as a going concern exists. The financial statements do not include adjustments relating to the recoverability of recorded assets nor the implication of associated bankruptcy costs should the Company be unable to continue as a going concern.

NOTE 4 – COMMON STOCK

As of June 30, 2018, GCT had 100,000,000 authorized shares of common stock of which 11,338,700 was issued and outstanding. Although the Company has had difficulty in obtaining working lines of credit from financial institutions and trade credit from vendors, management has been able to raise capital from private placements and further expand the Company's operations to continue its growth. In addition, The Company has issued shares as compensation for services provided.

Since inception, the Company has issued stock (initially membership interests in the Texas LLC which were subsequently converted into shares of the Company) as follows:

During the year ended December 1, 2013, 9,800,000 shares were awarded to the Founder for his efforts in starting the Company. These shares were issued at a discount to par value. Also, during that same year 131,000 shares were issued for cash of $56,500 and 102,000 shares valued at $49,750 were issued in payment of services provided to the Company.

During the year ended December 31, 2014, an additional 20,000 shares were issued for $5,000 cash and 50,000 shares valued at $25,000 were issued in payment of services provided to the Company.

During the year ended December 31, 2015, an additional 230,000 shares were issued for cash of $57,500 and 3,000 shares valued at $750 were issued as payment of services provided to the Company.

During the year ended December 31, 2016, an additional 108,000 shares were issued for cash of $44,500 and 80,000 shares valued at $27,500 were issued as payment of services provided to the Company.

During the year ended December 31, 2017, an additional 331,000 shares were issued for cash of $77,500 and 342,300 shares valued at $144,575 were issued as payment of services provided to the Company.

During the period ended June 30, 2018, the Company has issued 71,400 shares of common stock for $25,700 in cash and 282,500 shares for payment of services provided to the Company.

NOTE 5 – RELATED PARTY TRANSACTIONS

On January 2, 2013, Global Cancer Technology LLC, a Texas limited liability company awarded membership interests of 9,800,000 share equivalents to its Founder and Chief Executive Officer. The Founder shares were issued at a discount to par value

On May 18, 2017, in connection with the conversion of the Texas limited liability company into Global Cancer Technology, Inc., a Nevada Corporation, the Company converted the Founder membership interests into 9,800,000 shares of common stock in return for his interest in the Texas company.

On October 1, 2017, GCT entered into an exclusive distributorship agreement with American Radiosurgery, Inc., an entity controlled by the Founder. No payments have been made to American Radiosurgery since commencement of the agreement.

The Company has been accruing compensation of $75,000 per annum for its sole officer from inception to April 30, 2018. On May 1,2018 the Company entered into an executive agreement with the officer for an annual compensation of $100,000 per annum. At June 30, 2018 and 2017, the balance of unpaid compensation was $76,630 and $92,527, respectively.

NOTE 6 – COMMITMENTS AND CONTINGENCIES

GCT was formed to acquire a portfolio of various medical licenses for unique and promising patents and intellectual properties. The company has acquired licenses from the University of California, San Diego, John Moores Cancer Center (USCD) and from the University of Washington (UW) for several patents governing the use of advanced High Intensity Focused Ultrasound to treat cancer. In addition, we hold an exclusive technology license from American Radiosurgery, Inc (ARI)., an affiliated entity, to promote and sell high technology radiosurgery and cancer treatment products. The licenses we hold have financial terms that require certain minimum payments and include:

Licenses with UCSD

GCT is required to make certain payments to UCSD to maintain the license the two licenses it has with them. The financial obligations are as follows:

GCT has agreed to diligently develop, manufacture, and sell the licensed products, and have further agreed to accomplish certain tasks or milestones related to the technology. If GCT fails to perform these tasks, USCD may either terminate the agreement or change the license to a non-exclusive one. GCT has further agreed to obtain all necessary government approvals for the manufacture, use, and sale of the licensed products and to fill market demand for them.

UCSD may terminate the license agreement generally if GCT is delinquent in any reports or payments, if it does not diligently develop and commercialize the licensed product, if it breaches any provision of the agreement, subject to the right to cure any default within 60 days after receiving notice of default. GCT may terminate the agreement for any reason upon 90 days’ written notice. The term of the license agreement expires on the date of the longest-lived patent right granted under the license.

License with American Radiosurgery Distributorship Agreement

On October 1, 2017, GCT entered into an exclusive worldwide Technology License Agreement with American Radiosurgery, Inc. (ARI) to market and service products developed by American Radiosurgery, a related party via common ownership of our principal shareholder. Under the terms of the agreement, GCT will receive a commission on sales of the devices and are obligated to sell at least one device per year. Since commencement of the agreement, GCT has not sold any ARI devices.

GCT is also required to provide all warranty work for existing devices sold by American Radiosurgery and devices sold by GCT. There are 6 devices currently installed which are covered by warranty.

GCT is also permitted to provide removal services for existing devices throughout the world.

The agreement may be terminated by American Radiosurgery upon 30 days’ prior notice by American Radiosurgery if GCT fails to meet its selling quotas, or by either party for breach of the agreement or without cause.

Note 7 – Convertible Notes Payable

On November 20, 2017, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued

interest earned are due and payable on November 20, 2018 unless the option to convert into common shares at the rate of $0.25 per share is exercised. At December 31, 2017, the note has earned interest of $197.

On November 22, 2017, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on November 22, 2018 unless the option to convert into common shares at the rate of $0.25 per share is exercised. At December 31, 2017, the note has earned interest of $187.

On December 22, 2017, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on December 22, 2018 unless the option to convert into common shares at the rate of $0.25 per share is exercised. At December 31, 2017, the note has earned interest of $43.

On January 18, 2018, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on January 18, 2019 unless the option to convert into common shares at the rate of $0.25 per share is exercised.

On April 5, 2018, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on April 5, 2019 unless the option to convert into common shares at the rate of $0.25 per share is exercised.

On April 16, 2018, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on April 16, 2019 unless the option to convert into common shares at the rate of $0.25 per share is exercised.

On June 22, 2018, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on June 22, 2019 unless the option to convert into common shares at the rate of $0.25 per share is exercised.

Note 8 - 2018 Stock Incentive Plan

On May 1, 2018, our board of directors adopted the 2018 Stock Incentive Plan (the “Plan”) which was subsequently approved by a majority of the outstanding votes of our shareholders. The purposes of the Plan are (a) to enhance our ability to attract and retain the services of qualified employees, officers, directors, consultants, and other service providers upon whose judgment, initiative and efforts the successful conduct and development of our business largely depends, and (b) to provide additional incentives to such persons or entities to devote their utmost effort and skill to the advancement and betterment of our company, by providing them an opportunity to participate in the ownership of our Company and thereby have an interest in the success and increased value of our Company.

There are 500,000 shares of common stock authorized for non-qualified and incentive stock options, restricted stock units, restricted stock grants, and stock appreciation rights under the Plan, which are subject to adjustment in the event of stock splits, stock dividends, and other situations.

Note 9 – Subsequent Events

Subsequent to June 30, 2018, an additional 112,500 shares of common stock were issued for services rendered.

On July 27, 2018, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on July 27, 2019 unless the option to convert into common shares at the rate of $0.25 per share is exercised.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and
Stockholders of Global Cancer Technologies, Inc. and Subsidiaries

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheet of Global Cancer Technologies, Inc. and Subsidiaries (the “Company”) as of December 31, 2017 and 2016, and the related consolidated statements of operations, stockholders’ deficit, and cash flows for each of the years in the two-year period ended December 31, 2017, and the related consolidated notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2017 and 2016, and the consolidated results of its operations and its cash flows for the years in the two-year period ended December 31, 2017, in conformity with accounting principles generally accepted in the United States of America.

Emphasis of Matter – Going Concern

The accompanying consolidated financial statements have been prepared to assume the Company will continue as a going concern. As discussed in Note 3 to the consolidated financial statements, the Company’s losses from operations raise doubt about its ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Ankit Consulting Services, Inc.

We have served as the Company’s auditor since December 2017.

Rancho Santa Margarita, California

August 29, 2018

Global Cancer Technology, Inc.

Consolidated Balance Sheets

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

Global Cancer Technology, Inc.

Consolidated Statements of Operations

For the Years Ended December 31, 2017 and 2016

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

Global Cancer Technology, Inc.

Consolidated Statement of Stockholders' Deficit

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

Global Cancer Technology, Inc.

Consolidated Statement of Cash Flows

For the Years Ended December 31, 2017 and 2016

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

Global Cancer Technology, Inc.

Notes to Consolidated Financial Statements

NOTE 1 - ORGANIZATION AND DESCRIPTION OF BUSINESS

Global Cancer Technology, Inc. (GCT or The Company) was incorporated under the laws of the State of Nevada on May 18, 2017. It was originally formed as a limited liability company in the State of Texas on January 2, 2013 and converted to its present corporate status on May 18, 2017.

On July 12, 2017 the Company filed Articles of Incorporation in the State of Nevada for a subsidiary called NanoMed Tracking Inc. (NanoMed). GCT is a 51% owner of NanoMed and the minority owners are scientists integral to the development of the licensed products.

Business Overview

GCT has no products or services which we provide, except in connection with our license agreement with American Radiosurgery described below. We have acquired licenses from universities which permit us to market certain technologies.

GCT was formed to acquire a portfolio of various medical licenses for unique and promising patents and intellectual properties. The company has acquired licenses from the University of California, San Diego - John Moores Cancer Center and from the University of Washington. In addition, GCTholds an exclusive technology license from American Radiosurgery, Inc., an affiliated entity, to promote and sell high technology radiosurgery and cancer treatment products.

GCT is a startup stage company and has not yet achieved meaningful operating status.

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES

This summary of significant accounting policies of GCT is presented to assist in understanding the Company's financial statements. The financial statements and notes are representations of the Company's management, which is responsible for their integrity and objectivity. These accounting policies conform to accounting principles generally accepted in the United States and have been consistently applied in the preparation of the financial statements.

Basis of Presentation

The accompanying financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America ("US GAAP") and include the accounts of the Company and its subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.

Cash and Cash Equivalents

Cash and cash equivalents consist of deposits in one large national bank. At December 31, 2017 and 2016 respectively, the Company had $34,850 and $2,204 in cash. The Company has not experienced any losses in such accounts and believes it is not exposed to any risks on its cash in bank accounts.

Use of Estimates

The preparation of financial statements in accordance with generally accepted accounting principles requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities known to exist as of the date the financial statements are published, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates and assumptions and could have a material effect on the reported amounts of the Company's financial position and results of operations.

Property and Equipment

Property and equipment is stated at cost and depreciated using the straight-line method over the estimated useful life of the asset. Equipment at December 31, 2017 consisted of computer equipment.

Fair Value of Financial Instruments

The Company's financial instruments as defined by ASC 825-10-50, include cash, receivables, accounts payable and accrued expenses. All instruments are accounted for on a historical cost basis, which, due to the short-term maturity of these financial instruments, approximates fair value at December 31, 2017 and 2016.

Earnings (Losses) Per Share

Basic net loss per share was computed by dividing the net loss by the weighted average number of shares outstanding during the year. The weighted average number of shares was calculated by taking the number of shares outstanding and weighting them by the amount of time they were outstanding. Weighted average of number of diluted securities was the same as weighted average of basic securities because the effect of dilutive securities was non-dilutive.

Provision for Taxes

Income taxes are provided based upon the liability method of accounting pursuant to ASC 740-10-25 Income Taxes — Recognition. Under the approach, deferred income taxes are recorded to reflect the tax consequences in future years of differences between the tax basis of assets and liabilities and their financial reporting amounts at each year-end. A valuation allowance is recorded against deferred tax assets if management does not believe the Company has met the "more likely than not" standard imposed by ASC 740-10-25-5 to allow recognition of such an asset.

New Accounting Pronouncements

The Company has evaluated the authoritative guidance issued during the year ended December 31, 2017 and does not expect the adoption of these standards to have a material effect on its financial position or results of operations.

Note 3 - Going Concern

The accompanying financial statements have been prepared on a going concern basis, which assumes the Company will be able to realize its assets and settle its liabilities in the ordinary course of business. In the foreseeable future. As shown in the accompanying financial statements, the Company has incurred operating losses since inception. As of December 31, 2017, the Company has limited financial resources with which to achieve its objectives and obtain profitability and positive cash flows. As shown in the accompanying balance sheets and statements of operations, as of December 31, 2017 the Company has an accumulated deficit of $703,125 and The Company's working capital is a deficit of $215,598. Achievement of the Company's objectives will be dependent upon the ability to obtain additional financing, and generate revenue from current and planned business operations, and control costs. The Company is in the development stage and has generated no operating income.

The Company plans to fund its future operations by obtaining additional financing from investors and/or lenders. However, there is no assurance that the Company will be able to achieve these objectives, therefore substantial doubt about its ability to continue as a going concern exists. The financial statements do not include adjustments relating to the recoverability of recorded assets nor the implication of associated bankruptcy costs should the Company be unable to continue as a going concern.

Note 4 – Common Stock

As of December 31,2017, GCT had 100,000,000 authorized shares of common stock, par value $.001 per share, of which 11,197,300 was issued and outstanding. Although the Company has had difficulty in obtaining working lines of credit from financial institutions and trade credit from vendors, management has been able to raise capital from private placements and further expand the Company's operations to continue its growth. In addition, The Company has issued shares as compensation for services provided.

Since inception through December 31, 2015, the Company has issued stock (initially membership interests in the Texas LLC which were subsequently converted into shares of the Company) as follows:

During the year ended December 1, 2013, 9,800,000 shares were awarded to the Founder for his efforts in starting the Company. These shares were issued at a discount to par value. Also, during that same year 131,000 shares were issued for cash of $56,500 and 102,000 shares valued at $49,750 were issued in payment of services provided to the Company.

During the year ended December 31, 2014, an additional 20,000 shares were issued sold for $5,000 cash and 50,000 shares valued at $25,000 were issued in payment of services provided to the Company.

During the year ended December 31, 2015, an additional 230,000 shares were issued for cash of $57,500 and 3,000 shares valued at $750 were issued as payment of services provided to the Company.

During the year ended December 31, 2016, an additional 108,000 shares were issued for cash of $44,500 and 80,000 shares valued at $27,500 were issued as payment of services provided to the Company.

During the year ended December 31, 2017, an additional 331,000 shares were issued for cash of $77,500 and 342,300 shares valued at $144,575 were issued as payment of services provided to the Company.

NOTE 5 – RELATED PARTY TRANSACTIONS

On January 2, 2013, Global Cancer Technology LLC, a Texas limited liability company awarded membership interests of 9,800,000 share equivalents to its Founder and Chief Executive Officer. The Founder shares were issued at a discount to par value

On May 18, 2018, in connection with the conversion of the Texas limited liability company into Global Cancer Technology, Inc., a Nevada Corporation, the Company converted the Founder membership interests into 9,800,000 shares of common stock in return for his interest in the Texas company.

On October 1, 2017, GCT entered into an exclusive distributorship agreement with American Radiosurgery, Inc., an entity controlled by the Founder. No payments have been made to American Radiosurgery since commencement of the agreement.

The Company has been accruing compensation of $75,000 per annum for its sole officer from inception to April 30, 2018. Subsequent to year end the Company entered into an executive agreement with the officer for an annual compensation of $100,000 per annum. At December 31, 2017 and 2016, the balance of unpaid compensation was $101,224 and $43,242, respectively.

In 2016, commissions of $10,000 were paid to a relative of its sole officer as a consulting fee for securing the sale of equipment.

NOTE 6 – COMMITMENTS AND CONTINGENCIES

GCT was formed to acquire a portfolio of various medical licenses for unique and promising patents and intellectual properties. The company has acquired licenses from the University of California, San Diego, John Moores Cancer Center (USCD) and from the University of Washington (UW) for several patents governing the use of advanced High Intensity Focused Ultrasound to treat cancer. In addition, we hold an exclusive technology license from American Radiosurgery, Inc (ARI)., an affiliated entity, to promote and sell high technology radiosurgery and cancer treatment products. The licenses we hold have financial terms that require certain minimum payments and include:

Licenses with UCSD

GCT is required to make certain payments to UCSD to maintain the license the two licenses it has with them. The financial obligations are as follows:

GCT has agreed to diligently develop, manufacture, and sell the licensed products, and have further agreed to accomplish certain tasks or milestones related to the technology. If GCT fails to perform these tasks, USCD may either terminate the agreement or change the license to a non-exclusive one. GCT has further agreed to obtain all necessary government approvals for the manufacture, use, and sale of the licensed products and to fill market demand for them.

UCSD may terminate the license agreement generally if GCT is delinquent in any reports or payments, if it does not diligently develop and commercialize the licensed product, if it breaches any provision of the agreement, subject to the right to cure any default within 60 days after receiving notice of default. GCT may terminate the agreement for any reason upon 90 days’ written notice. The term of the license agreement expires on the date of the longest-lived patent right granted under the license.

License with American Radiosurgery Distributorship Agreement

On October 1, 2017, GCT entered into an exclusive worldwide Technology License Agreement with American Radiosurgery, Inc. (ARI) to market and service products developed by American Radiosurgery, a related party via common ownership of our principal shareholder. Under the terms of the agreement, GCT will receive a commission on sales of the devices and are obligated to sell at least one device per year. Since commencement of the agreement, GCT has not sold any ARI devices.

GCT is also required to provide all warranty work for existing devices sold by American Radiosurgery and devices sold by GCT. There are 6 devices currently installed which are covered by warranty.

GCT is also permitted to provide removal services for existing devices throughout the world.

The agreement may be terminated by American Radiosurgery upon 30 days’ prior notice by American Radiosurgery if GCT fails to meet its selling quotas, or by either party for breach of the agreement or without cause.

Note 7 – Convertible Notes Payable

On November 20, 2017, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on November 20, 2018 unless the option to convert into common shares at the rate of $0.25 per share is exercised. At December 31, 2017, the note has earned interest of $197.

On November 22, 2017, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on November 22, 2018 unless the option to convert into common shares at the rate of $0.25 per share is exercised. At December 31, 2017, the note has earned interest of $187.

On December 22, 2017, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on December 22, 2018 unless the option to convert into common shares at the rate of $0.25 per share is exercised. At December 31, 2017, the note has earned interest of $43.

NOTE 8 – SUBSEQUENT EVENTS

Issuance of Additional Convertible Promissory Notes

On January 18, 2018, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on January 18, 2019 unless the option to convert into common shares at the rate of $0.25 per share is exercised.

On April 5, 2018, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on April 5, 2019 unless the option to convert into common shares at the rate of $0.25 per share is exercised.

On April 16, 2018, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on April 16, 2019 unless the option to convert into common shares at the rate of $0.25 per share is exercised.

On June 22, 2018, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on June 22, 2019 unless the option to convert into common shares at the rate of $0.25 per share is exercised.

On July 27, 2018, the Company received $25,000 cash in exchange for an unsecured convertible note agreement. The $25,000 note bears interest at 7% per annum. The note balance and accrued interest earned are due and payable on July, 2019 unless the option to convert into common shares at the rate of $0.25 per share is exercised.

License with the University of Washington

Effective March 8, 2018, GCT entered into an exclusive world-wide Start-up License Agreement with the University of Washington under certain patents licensed by the university and a non-exclusive world-wide license for certain know-how for the development and commercialization of a new form of High Intensity Focused Ultrasound called ‘Boiling Histotripsy’. GCT has the right to grant sublicenses for the licensed technology. Because the inventions covered by the licensed patents arose in whole or in part from federally supported research, the federal government has certain statutory rights to the technology. GCT has agreed to use commercially reasonable efforts to commercialize the licensed rights and is obligated within 30 days after each calendar year-end to submit reports describing these efforts.

GCT may terminate the agreement at any time, or the License Agreement will terminate when all licensed rights have terminated or if GCT breaches any of our material duties under the agreement.

Emyployment Agreement

On May 1, 2018 the Company entered into an employment agreement with its sole officer. Under the terms of agreement, the officer is entitled to compensation of $100,000 per annum. In addition, GCT issued the officer 100,000 shares of common stock as a signing bonus. He is also eligible to receive an annual bonus of a minimum of 50% and a maximum of 400% upon achievement of performance objectives, none of which have yet been determined. He is also entitled to participate in employee benefits available to other senior executives and 12 weeks paid vacation per year.

2018 Stock Incentive Plan

On May 1, 2018, our board of directors adopted the 2018 Stock Incentive Plan (the “Plan”) which was subsequently approved by a majority of the outstanding votes of our shareholders. The purposes of the Plan are (a) to enhance GCT’s ability to attract and retain the services of qualified employees, officers, directors, consultants, and other service providers upon whose judgment, initiative and efforts the successful conduct and development of the business largely depends, and (b) to provide additional incentives to such persons or entities to devote their utmost effort and skill to the advancement and betterment of the company, by providing them an opportunity to participate in the ownership of the Company and thereby have an interest in the success and increased value of the Company.

There are 500,000 shares of common stock authorized for non-qualified and incentive stock options,

restricted stock units, restricted stock grants, and stock appreciation rights under the Plan, which are subject to adjustment in the event of stock splits, stock dividends, and other situations.

Additional Issuance of Common Stock

Subsequent to December 31, 2017, the Company has issued 71,400 shares of common stock for $25,700 in cash and 282,500 shares for payment of services provided to the Company.

Incorporation of Subsidiary

On June 11, 2018 the Company filed Articles of Incorporation in the State of Montana for a subsidiary called MCW Pharmaceuticals Inc. (MCW). The Company intends to transfer into this subsidiary a license obtained from UCSD. GCT is a 51% owner of MCW and the minority owners are scientists integral to the develop of the licensed products.

PART III

EXHIBITS TO OFFERING STATEMENT

SIGNATURES

Pursuant to the requirements of Regulation A, the issuer certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form 1-A and has duly caused this offering statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Diego, CA on November 7, 2018 .

This offering statement has been signed by the following persons in the capacities and on the dates indicated.