1035 Pearl Street, Suite 403

Boulder, CO 80302

Tel. (720) 259-3393

Fax. (303) 845-7315

Approximate date of commencement of proposed sale to the public: As soon as practicable and from time to time after the effective date of this Registration Statement.

We expect to incur operating losses in future periods. These losses will occur because we do not yet have anysubstantial expenses without corresponding revenues to offset the expenses associated with the development of our composite materialsunless and our business operations, generally. We cannot guarantee that we will ever be successful in generating revenues in the future. We recognize that ifuntil we are unableable to generate revenues, we will notobtain regulatory approval and successfully commercialize the proposed products.

We may never be able to earn profitsobtain regulatory approval for one or continue operations. Theremore of the products in any indication in the United States or internationally. Even if our regulatory process is no history upon which to base any assumption as to the likelihood that we will prove successful and wewith one or more of our product candidates, there can provide investors withbe no assurance that we will generate any operatingsignificant revenues or ever achieve profitableprofitability.

The ongoing COVID-19 pandemic may adversely affect our business.

In December 2019, a strain of coronavirus was reported to have surfaced in Wuhan, China, and has spread globally, and on March 12, 2020, the WHO declared COVID-19 to be a pandemic. In an effort to contain and mitigate the spread of COVID-19, many countries, including the United States, have imposed unprecedented restrictions on travel, quarantines, and other public health safety measures. Such government-imposed precautionary measures may have been relaxed in certain countries or states, but there is no assurance that more strict measures will be put in place again due to a resurgence in COVID-19 cases. The rapidly evolving nature of the circumstances is such that it is impossible, at this stage, to determine the full and overall impact the COVID-19 pandemic may have, but it could disrupt production and cause delays in the supply and delivery of products used in our research and development efforts, adversely affect our employees, and disrupt our operations, all of which may have a material adverse effect on our business. In addition, the pandemic may have an adverse effect on the ability of regulatory bodies to grant approvals or supervise our candidates and products, may further divert the attention and efforts of the medical community to coping with the coronavirus and disrupt the marketplace in which we operate and may have a material adverse effects on our operations. If we are unsuccessful

Moreover, the COVID-19 pandemic has created significant economic uncertainty and volatility in addressing these risks,the credit and capital markets. Management plans to secure the necessary financing through the issue of new equity and/or the entering into of strategic partnership arrangements; however, there is no assurance that our businessmanagement will almost certainly fail.

In addition, a significant strain on our limited personnel, management, andoutbreak of COVID-19 or other resources. Our future success depends upon the continued services of our executive officers who are developing our business, and on our ability to identify and retain competent consultants and employees with the skills required to execute our business objectives. The loss of the services of Michael Winterhalter or our failure to timely identify and retain competent personnelinfectious diseases could negatively impact our ability to develop our website and sell our services, whichresult in a widespread health crisis that could adversely affect our financial results and impair our growth.

Clinical drug development involves a lengthy and expensive process with U.S. Department of Commerce regulations in shipping exporting technologies outside the United States. Any significant future difficulty in complying with such regulations could harm our business, financial conditionan uncertain outcome, and results of operations.

In addition, even if we obtain regulatory approvals, the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approvaltiming or scope of any golden parachute payments not previously approved. We cannot predictapprovals may prohibit or reduce our ability to successfully commercialize these products. For example, if investors will find our common stock less attractive becausethe approval process takes too long, the Company may miss market opportunities and give other companies the ability to develop competing products or establish market dominance. Any regulatory approval we will rely on these exemptions. If some investors find our common stock less attractive as a result, thereultimately obtain may be limited or subject to restrictions or post-approval commitments that render one or more products not commercially viable. For example, regulatory authorities may approve a less active trading marketproduct for fewer or more limited indications than requested, may not approve the price we intend to charge, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that indication. Further, the FDA or comparable foreign regulatory authorities may place conditions on approvals, such as risk management plans and a Risk Evaluation and Mitigation Strategy, or REMS, to assure the safe use of the drug. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS; the FDA will not approve the NDA without an approved REMS, if required. A REMS could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA may also require a REMS for an approved product when new safety information emerges. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of our common stock and our stock priceproducts. Moreover, product approvals may be more volatile.

Even once marketing approval is obtained, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, these products could be subject to labeling and other restrictions and withdrawal from the same newmarket and we may be subject to penalties if we fail to comply with regulatory requirements or revised accounting standards asif we experience unanticipated problems with the proposed products.

Even if we obtain marketing approval for our drug candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our drug candidates could be subject to labeling and other public companiesrestrictions and withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our drug candidates.

Even if we obtain United States regulatory approval of for a specific indication, the FDA may still impose significant restrictions on indicated uses or marketing or the conditions of approval, or impose ongoing requirements for potentially costly and time-consuming post-approval studies, including Phase 4 clinical trials, and post-market surveillance to monitor safety and efficacy. The proposed products will also be subject to ongoing regulatory requirements governing the manufacturing, labeling, packaging, storage, distribution, safety surveillance, advertising, promotion, recordkeeping and reporting of adverse events and other post-market information. These requirements include registration with the FDA, continued compliance with current Good Clinical Practices regulations, or cGCPs, for any clinical trials that we conduct post-approval, continued compliance with the CSA and ongoing review by the DEA. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current Good Manufacturing Practices, or cGMP, requirements relating to quality control, quality assurance and corresponding maintenance of records and documents.

With respect to sales and marketing activities by us or any future partner, advertising and promotional materials must comply with FDA rules in addition to other applicable federal, state and local laws in the United States and similar legal requirements in other countries. In the United States, the distribution of product samples to physicians must comply with the requirements of the U.S. Prescription Drug Marketing Act. Application holders must obtain FDA approval for product and manufacturing changes, depending on the nature of the change. We may also be subject, directly or indirectly through our customers and partners, to various fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute, U.S. False Claims Act, and similar state laws, which impact, among other things, our proposed sales, marketing, and scientific/educational grant programs. If we participate in the U.S. Medicaid Drug Rebate Program, the Federal Supply Schedule of the U.S. Department of Veterans Affairs, or other government drug programs, we will be subject to complex laws and regulations regarding reporting and payment obligations. All of these activities are also potentially subject to U.S. federal and state consumer protection and unfair competition laws. Similar requirements exist in many of these areas in other countries.

In addition, if the product(s) are approved for an indication, our product labeling, advertising and promotion would be subject to regulatory requirements and continuing regulatory review. The FDA strictly regulates the promotional claims that may be made about prescription products. In particular, a product may not be promoted for uses that are not “emerging growth companies.”

The occurrence of any golden parachute payments not previously approved. event or penalty described above may inhibit our ability to commercialize these products and generate revenue. Adverse regulatory action, whether pre- or post-approval, can also potentially lead to product liability claims and increase our product liability exposure.

We intend to take advantage of these reporting exemptions untilcurrently have no sales and marketing organization. If we are no longer an “emerging growth company.”

We currently have no sales and marketing organization. If we are unable to secure a sales and marketing partner or establish satisfactory sales and marketing capabilities, we may not successfully commercialize the proposed products.

The Company may not be able to enter into collaboration agreements on terms acceptable to us or at all. In addition, even if we enter into such relationships, we may have limited or no control over the sales, marketing and distribution activities of these third parties. Our future revenues may depend heavily on the success of the efforts of these third parties. If we elect to establish a sales and marketing infrastructure we may not realize a positive return on this investment. In addition, we will have to compete with established and well-funded pharmaceutical and biotechnology companies to recruit, hire, train and retain sales and marketing personnel. Factors that may inhibit our efforts to commercialize the products without strategic partners or licensees include:

The Company faces competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.

The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. We have competitors in a number of jurisdictions, many of which have substantially greater name recognition, commercial infrastructures and financial, technical and personnel resources than we have. Established competitors may invest heavily to quickly discover and develop novel compounds that could make these product candidates obsolete or uneconomical. Any new product that competes with an approved product may need to demonstrate compelling advantages in efficacy, cost, convenience, tolerability and safety to be commercially successful. Other competitive factors, including generic competition, could force us to lower prices or could result in reduced sales. In addition, new products developed by others could emerge as competitors. If we are not able to compete effectively against our common stock quoted on a public trading market, your common stockcurrent and future competitors, our business will not have a quantifiable valuegrow and itour financial condition and operations will suffer.

We may be difficult, if not impossible,involved in legal proceedings that may result in adverse outcomes.

We may be involved in claims, suits, government investigations, and proceedings arising in the ordinary course of our business, including actions with respect to ever resell your shares, resulting in an inability to realize any value from your investment.

Financial and Other Risk Factors

Any market that develops in shares of money to you. If that happens, you will lose your investment and your funds will be used to pay creditors.

The trading of our securities, if any, will be in the over-the-counter market which is commonly referred to as the “OTC”. As a result, an investor may find it difficult to dispose of, or to obtain accurate quotations as to the price of our securities.

Broker-dealer practices in connection with transactions in “penny stock”. Pennystocks” are regulated by penny stock rules adopted by the SEC. The term “penny stock” is any equity security that hasdefined in Exchange Act Rule 3a51-1 as, among other things, as having a market price of less than $5.00 per share subject to certain exceptions. For any transaction involving aas set forth in Exchange Act Rule 3a51-(1)(d). The penny stock unless exempt, the rules require that a broker or dealer approve a potential investor’s account for transactions in penny stocks, and the broker or dealer receive from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased. In order to approve an investor’s account for transactions in penny stocks, the broker or dealer must obtain financial information and investment experience objectives of the person, and make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks. The broker or dealer must also deliver,broker-dealer, prior to anya transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure schedule prepared bydocument that provides information about penny stocks and the Commission relatingnature and level of risks in the penny stock market.

The broker-dealer also must 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, and, if the broker-dealer is the sole market maker, the broker-dealer must disclose this fact and the broker-dealer’s presumed control over the market, and monthly account statements showing the market value of each penny stock held in the customer’s account. In addition, broker-dealers who sell these securities to persons other than established customers and “accredited investors” must 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. Consequently, these requirements may have the effect of reducing the level of trading activity, if any, in the secondary market for a security subject to the penny stock market, which,rules, and investors in highlight form sets forth the basis on which the broker or dealer made the suitability determination. Brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more difficult for investors to dispose of our common stock and cause a decline in the market value of our stock. may find it difficult to sell their shares.

Disclosure also has to be made about the risks of investing in penny stocksstock in both public offerings and in secondary trading and about the commissions payable to both the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies available to an investor in cases of fraud in penny stock transactions. Finally,Additionally, monthly statements have to be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks.

If we are unable to implement and maintain effective internal control over financial reporting in the future, the accuracy and timeliness of us, which in turn could reduce our stock price or prevent our stockholders from realizing a premium over our stock price.

We do not intend to seek registrationpay dividends for the foreseeable future.

We have never declared or qualification of its shares ofpaid any cash dividends on our common stock the subject of this offering in any State or territory of the United States. Aside from a “secondary trading” exemption, other exemptions under state law and the laws of US territories may be available to purchasers of the shares of common stock sold in this offering,

Prospective investors need to conduct an independent investment analysis and due diligence review.

No independent legal, accounting or business advisors have been appointed to represent the interests of prospective investors in the Company. Neither the Company nor any of its officers, directors, employees or agents makes any representation or expresses any opinion with respect to the merits of an investment in the shares unless they sell them. Stockholdersof the Company, including, without limitation, the proposed value of the Company or the shares. Each prospective investor is therefore encouraged to engage independent accountants, appraisers, attorneys and other advisors to (i) conduct such due diligence review as such prospective investor may never be abledeem necessary and advisable, and (ii) provide such opinions with respect to sell shares when desired. Before you investthe merits of an investment in our securities, you should be aware that there are various risks. You should consider carefully thesethe Company and applicable risk factors togetheras such prospective investor may deem necessary and advisable. The Company will cooperate fully with any prospective investor who desires to conduct such an independent analysis, so long as the Company determines, in its sole discretion, that such cooperation is not unduly burdensome.

Prospective investors need to review individual tax consequences of an investment in the Company.

An investment in the Company will have certain tax consequences that will be unique to each investor, depending upon his/her/its personal tax situation, his/her/its nationality and/or place of domicile, and other unique personal circumstances. The Company cannot and does not make any representations or assurances as to individual tax consequences. Investors are encouraged to consult with their own tax advisors in connection with any investment decision with respect to the shares.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward looking statements reflecting our current expectations that involve risks and uncertainties. These forward-looking statements include, but are not limited to, statements related to industry prospects, our future economic performance including anticipated revenues and expenditures, results of operations or financial position, and other financial items, our business plans and objectives, including our growth strategies and intended product releases, and may include certain assumptions that underlie the forward-looking statements. Forward-looking statements often include words such as “outlook,” “projected,” “intends,” “will,” “anticipate,” “believe,” “target,” “expect,” and statements in the future tense are generally forward-looking.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. The achievement or success of the matters covered by such forward-looking statements involves significant risks, uncertainties and assumptions, including those described in “Risk Factors” beginning on page 3 of this prospectus. Moreover, we operate in a very competitive and rapidly changing environment and industry. New risks may also emerge from time to time. It is not possible for our management to predict all of the other information includedrisks related to our business and operations, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this annual report before you decide to purchase our securities. If anyprospectus may not occur and actual results could differ materially and adversely from those anticipated, predicted or implied in the forward-looking statements.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the followingforward-looking statements will be achieved or occur, and reported results should not be considered as an indication of future performance. Given these risks and uncertainties, develop intoreaders are cautioned not to place undue reliance on such forward-looking statements.

Except as required by law, we undertake no obligation to update any forward-looking statements for any reason to conform these statements to actual events,results or to changes in our business, financial condition or results of operations could be materially adversely affected.

All shares of 750,000 isour common stock offered by this prospectus are being made on a self-underwritten basis: no minimum number of shares must be sold in orderregistered for the offering to proceed. The net proceeds to us from the sale of up to 750,000 shares offered at a public offering price of $1.00 per share will vary depending upon the total number of shares sold. Regardlessaccounts of the number of shares sold,selling stockholders and we expect to incur offering expenses estimated at $4,726 for legal, accounting, printing and other costs in connection with this offering (see “Other Expenses of Issuance and Distribution” in Part II). We will not receive any proceeds from the sale of shares by the selling shareholders. We will not maintain an escrow account for the receipt of proceeds from the sale of ourthese shares.

DIVIDENDS

Historically, we have not register as a broker-dealer pursuant to Section 15 of the Exchange Act, but rather will rely upon the “safe harbor” provisions of SEC Rule 3a4-1, promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Generally speaking, Rule 3a4-1 provides an exemption from the broker-dealer registration requirements of the Exchange Act for persons associated with an issuer that participate in an offering of the issuer’s securities. Mr. Winterhalter is not subject topaid any statutory disqualification, as that term is defined in Section 3(a)(39) of the Exchange Act.

TRANSFER AGENT

Our transfer agent for our common stock is West Coast Stock Transfer, located atInc. (“West Coast Stock Transfer”), whose address 721 N. Vulcan Ave., Suite 205,Ave, Encinitas, California 92024. The agent’sWest Coast Stock Transfer’s telephone number is (619) 664-4780.

Overview

The Company was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by orincorporated in the rightState of the corporation) by reason of the fact that he or she is or was a director, officer, employee or agent of the corporation or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise (any such person, a “Covered Person”), against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the Covered Person in connection with such action, suit or proceeding if the Covered Person is not liable pursuant to Section 78.138 of the Nevada Law or the Covered Person acted in good faith and in a manner the Covered Person reasonably believed to be in or not opposed to the best interests of the corporation and, with respect to any criminal action or proceedings, had no reasonable cause to believe the Covered Person’s conduct was unlawful.

The Company accounts for income taxes under Section 740-10-30 of the FASB Accounting Standards Codification. Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than not that the assets will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the statements of operations in the period that includes the enactment date.

The Company adopted section 740-10-25 of the FASB Accounting Standards Codification (“Section 740-10-25”). Section 740-10-25 addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under Section 740-10-25, the Company may obtain copies of our reportsrecognize the tax benefit from an uncertain tax position only if it is more likely than not that the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549,tax position will be sustained on official business days duringexamination by the hours of 10 A.M. to 3 P.M. ortaxing authorities, based on the SEC’s website, at www.sec.gov. You may obtain informationtechnical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.

Results of Operations

Year Ended Periods Ended August 31, 2019 and August 31, 2018

For the year ended August 31, 2019, we generated revenues of $0. For the year ended August 31, 2018, we generated revenues of $0.

For the year ended August 31, 2019, we incurred operating expenses of $121,317, consisting of professional fees of $57,322, salary and wages of $60,000, and general and administrative expenses of $3,995. By way of comparison, for the year ended August 31, 2018, we incurred operating expenses of $134,376, consisting of professional fees of $45,593, salary and wages of $80,000, and general and administrative expenses of $8,783.

We incurred net losses of $132,652 and $42,788,953 for the years ended August 31, 2019 and 2018, respectively. The JOBS Act permits an “emerging growth company” such asfollowing table provides selected financial data about our company at August 31, 2019 and 2018.

Liquidity and Capital Resources

At August 31, 2019, we had a cash balance of $93, total current liabilities of approximately $40,878. Total expenditures over the next 12 months are expected to be approximately $350,000, in order to complete our 12-month plan of operation, more fully described in the paragraph below. If we experience a shortage of funds prior to generating revenues from operations we may utilize funds from our director, who has informally agreed to advance funds to allow us to take advantagepay for operating costs, however they have no formal commitment, arrangement or legal obligation to advance or loan funds to us. Management believes our current cash balance will not be sufficient to fund our operations for the next twelve months.

Off-Balance Sheet Arrangements

The Company has no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on the financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to stockholders.

BUSINESS

History

The Company was incorporated in the State of Nevada on April 18, 2013 and established a fiscal year end of August 31.Effective June 17, 2019, we changed our name from FairWind Energy, Inc. to better reflect the new focus of our business. We are a development stage corporation and have not yet generated or realized meaningful revenues from our business.

Until recently, our business plan focused on the design, engineering and manufacturing of composite products, specifically the supply products to the oil and gas industry. However, on May 28, 2020, entered into a Share Exchange Agreement (the “Share Exchange Agreement”) with GSL Healthcare, Inc., a Nevada corporation (“GSL Healthcare”), and the holders of common stock of GSL Healthcare, which consisted of two stockholders. The closing date occurred on June 1, 2020.

Under the terms and conditions of the Share Exchange Agreement, the Company offered and sold 27,932,271 shares of common stock of the Company in consideration for all of the issued and outstanding shares of common stock of GSL Healthcare. The effect of the issuance is that former two GSL Healthcare shareholders now hold approximately 88.0% of the issued shares of common stock of the Company, and GSL Healthcare is now a wholly-owned subsidiary of the Company. GSL Healthcare has a general plan to be a health and wellness business.

Overview

As a result of the Share Exchange Agreement, we plan to focus our business plan on the development and commercialization of novel therapeutics to treat metabolic diseases, peripheral neuropathy, progressive lung disease and ischemic reperfusion injury. Our principal business objective is to develop both science-driven synthetic and natural cannabinoid therapeutics that address unmet medical needs and continue to drive innovations in the endocannabinoid space.

Specifically, we have identified a targeted collection of wellness and pharmaceutical product opportunities, the majority of which will be designed to offer a more sophisticated and intelligent product offering in the multibillion dollar global biopharmaceutical industry.

Additionally, as a result of a Mater Development, License and Supply Agreement dated March 26, 2020, we have an extended transition periodexclusive partnership agreement with BIONOVA Labs, Inc., located in Long Island City, NY, surrounding the co-development and commercialization of a proprietary nanotechnology based on BIONOVA’s NuCell Technology.This technology was first developed by Dr. Michael Danielov (CEO and Founder) at the Institute of Experimental Morphology Academy of Science located in Georgia, Tbilisi of the USSR. This award-winning development was identified as a new scientific “Concept of Biological Information Transfer” which reshaped conventional approaches in medicine. With government funding, he recruited top scientists, engineers, mathematicians, physiologists, and biochemists to develop a new science and methodology surrounding the nano-structuring of bioactive substances. Dr. Danielov published a series of articles related to this proprietary Scientific Concept of “Biological Information Transfer” and to Life Science Nanotechnology in “Critical Care & Catastrope Medicine” magazines which can be found at http://www.cccm.ge/index_en.htm.

The bioactive ingredients, called NANO-COMPLEXES™, are delivered in ‘Nano’ quantities to be effectively utilized by the body; (http://www.bionovalab.com/bionova/Customer/bionovaAndNanotechnology.ms).Based on fundamental scientific research Dr. Danielov and his team of scientists developed several proprietary nanotechnologies for Life Science Industries, which currently are in use as a technological platform for creating multiple products oriented toward enhancement of self-healing processes. This technological platform is based on the development of Bioactive Complexes Modeling, which gives the ability to manipulate not only with Nano (10-9), but also with Pico (10-12) quantities of active substances, targeting the problem-specific biochemical pathway.

The ingredients in BIONOVA’s products are called NANO-COMPLEXES™ and include replicas of bioactive ingredients either existing in the human body or known to biologically react with natural receptors in the body that are vital for reestablishing or regulating cellular communication. These NANOCOMPLEXES ™ are easily recognized, absorbed and metabolized. Each BIONOVA product is composed of 150 to 300 ingredients that are specially selected for each individual’s personalized profile. The NANO-COMPLEXES™ are delivered into the targeted place with proprietary NuCell Direct™ Delivery System, a trademarked imitation of a human cell membrane, and based on molecular structure and densities, can be designed for a timed-controlled-release.

BIONOVA approach differs from the industrial nanotechnology, as well as from nanotechnological approach in health care industry, which is focusing today its attention only to the particle sizes of matter. BIONOVA products do not contain any engineered nanomaterials but include a combination of many ingredients (most ordinarily produced by the human body).These ingredients are presented in “nano and pico-amounts” (physiological amounts) - at a level that is most efficient for metabolic uptake in the tissue(s). This is the distinctive technology that is utilized only by BIONOVA.

This partnership with BIONOVA’s includes the development of novel Cannabinoid-Biocomplexes that shall include customized formulations for targeted delivery of bio-pharmacological elements for a variety of clinical indications identified in our business plan.

Biopharma Industry

The global demand for biopharmaceuticals is driven by a number of factors like increase in the elderly population, an increase in the prevalence of chronic diseases like cancer and diabetes, and an increase in the global acceptance of biopharmaceuticals. In addition, an increase in strategic partnerships between biopharmaceutical companies is also expected to complement the growth of the biopharmaceuticals industry. Furthermore, clearance for newer biopharmaceutical products and continuous R&D is also expected to improve this market positively. However, the high costs of these medications are one of the main constraints on this industry and, in order to make them economically viable, the cost needs to be reduced greatly.

The global market for the biopharma is segmented into product, therapeutic area, application, and region. Based on product, the market is for biopharma is segmented into recombinant growth factors, monoclonal antibodies, recombinant proteins, vaccines, purified proteins, recombinant hormones, and other product types. The monoclonal antibodies market is further divided into anti-inflammatory monoclonal antibodies, anti-cancer monoclonal antibodies, and other monoclonal antibodies. The purified proteins market is further bifurcated into P38 protein, leukemia inhibitory factor, P53 protein, and other purified proteins. The recombinant proteins market is further divided into serum albumin, defensin, amyloid protein, and transferrin. Vaccines are further divided into conventional vaccines, recombinant vaccines, and recombinant enzymes. The recombinant growth factors are further divided into granulocyte colony stimulating factors, and erythropoietin. The recombinant hormones market is further divided into recombinant human growth hormones, recombinant insulin, and other recombinant hormones. The market for monoclonal antibodies held almost 28% share of the market in 2019. Monoclonal antibodies are used in cancer treatment areas. Their usage is becoming increasingly widespread in developed countries like the U.S. and the U.K. Contrary, the recombinant proteins segment is expected to show rapid growth over the forecast period.

Segmentation Analysis

Based on therapeutic application, the market is categorized into oncology, inflammatory and infectious diseases, neurological diseases, infectious diseases, cardiovascular diseases, metabolic disorders, hormonal disorders, and other diseases. The oncology segment held almost 25% share of the market in 2019. According to the International Agency for Cancer Research (IARC), there were almost 18 million new cases of cancer and 10 million deaths in 2018. In fact, the United Nations Program on HIV and AIDS (UNAIDS) estimated that 37 million people were living with HIV in 2017. Such disquieting statistics has raised an urgent need to change the situation by innovating new and successful medicines that can cure such deadly diseases consequently raising the number of deaths. Apparently, biopharmaceutical drugs are considered to be effective in curing these chronic diseases rather than merely treating the same symptoms.

Regional Analysis

Regionally, the market is divided into Asia Pacific, Europe, Latin America, North America, and Middle East & Africa. North America held almost 37% in 2019 due to the presence of sophisticated healthcare facilities, increasing geriatric population base, and increased healthcare expenditure in the country. Asia Pacific is likely to grow at high CAGR in the forecast period. Increased investment in R&D, increased acceptance and availability of biopharmaceuticals for disease treatment and increased understanding of disease diagnosis are some of the factors of market growth in this region. Moreover, this area offers tremendous prospects for venture capitalists and investors as developed markets are largely saturated.

Competition

The biopharma industry is characterized by fierce competition, is growing rapidly, evolving constantly, and the possibility for innovative companies to succeed within it is significant. The biopharma industry is, in all respects, global and Agentix will have competitors around the world, including but not limited to the following: Novo Nordisk A/S (Denmark), Johnson & Johnson (U.S.), Pfizer, Inc., (U.S.), Hoffmann-La Roche (Switzerland), Eli Lilly and Company, Ltd. (U.K.), Biogen, Inc. (U.S.), Merck & Co., Inc. (U.S.), Sanofi (France), Bristol Myers Squibb Company (U.S.), and Bayer AG (Germany) among others.

Intellectual Property

We will rely on a combination of trademark laws, trade secrets, confidentiality provisions and other contractual provisions to protect our proprietary rights, which are primarily our brand names, product designs and marks. We do not own any patents, although we may apply for some in the future based on the success of our business plan.

Government Regulation

The process of obtaining regulatory approvals and the subsequent 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 requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. These sanctions could include the US FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.

Any product development activities related to Agentix or products that we may develop or acquire in the future will be subject to extensive regulation by various government authorities, including the FDA, other federal, state and local agencies and comparable regulatory authorities in other countries, which regulate the design, research, clinical and non-clinical development, testing, manufacturing, storage, distribution, import, export, labeling, advertising and marketing of pharmaceutical products and devices. Generally, before a new drug can be sold, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific to each regulatory authority, submitted for review and approved by the regulatory authority. The data are often generated in two distinct development states: pre-clinical and clinical.

The products that Agentix may develop or revised accountingacquire in the future must be approved by the FDA before they may be legally marketed in the United States. For new chemical entities, the pre-clinical development stage generally involves synthesizing the active component, developing the formulation and determining the manufacturing process, as well as carrying out non-human toxicology, pharmacology and drug metabolism studies that support subsequent clinical testing. These pre-clinical laboratory and animal tests are often performed under the FDA’s Good Laboratory Practices regulations. A drug’s sponsor must submit the result of the pre-clinical tests, together with manufacturing information, analytical data and any available clinical data or literature and a proposed clinical protocol to the FDA as part of an IND application, which is a request for authorization from the FDA to administer an investigational drug or biological product to humans. Similar filings are required in other countries.

Post-Marketing Requirements

Following approval of a new product, a pharmaceutical company and the approved product are subject to continuing regulation by the FDA and other federal and state regulatory authorities, including, among other things, monitoring and recordkeeping activities, reporting to applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards applicablefor direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations not described in the drug’s approved labeling (known as “off-label use”), and limitations on industry-sponsored scientific and educational activities. Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not market or promote such off-label uses. Modifications or enhancements to public companies.the products or labeling or changes of site of manufacture are often subject to the approval of the FDA and other regulators, which may or may not be received or may result in a lengthy review process. The FDA regulations require the products be manufactured in specific approved facilities and in accordance with current good manufacturing practices, and NDA holders must list their products and register their manufacturing establishments with the FDA. These regulations also impose certain organizational, procedural and documentation requirements with respect to manufacturing and quality assurance activities. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with current good manufacturing practice and other laws. NDA holders using contract manufacturers, laboratories or packagers are responsible for the selection and monitoring of qualified firms. These firms are subject to inspections by the FDA at any time, and the discovery of violative conditions could result in enforcement actions that interrupt the operation of any such facilities or the ability to distribute products manufactured, processed or tested by them.

Other Regulatory Matters

Manufacturing, sales, promotion and other activities following product approval are also subject to regulation by numerous regulatory authorities in addition to the FDA, including, in the United States, the Centers for Medicare & Medicaid Services, or CMS, other divisions of the Department of Health and Human Services, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency, and state and local governments. These regulations include:

Distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, traceability, and storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.

The handling of any controlled substances must comply with the U.S. Controlled Substances Act and the Controlled Substances Import and Export Act. In the U.S., many of our product candidates are currently classified as Schedule I controlled substance as defined in the Controlled Substance Act (“CSA”). This designation is based on many of AGENTIX’s chemical structures and pharmacology.

Schedule I controlled substances are pharmaceutical products subject to specific regulations under the CSA, that establishes, among other things, certain registration, manufacturing quotas, security, recordkeeping, reporting, import, export and other requirements administered by the DEA. All parties responsible for the manufacturing, distribution and testing the drug in clinical studies must apply for and obtain a license from the DEA before they are permitted to perform these activities with AGENTIX. Furthermore, these parties must have the security, control, recordkeeping, reporting and inventory mechanisms required by the DEA to prevent drug loss and diversion. All licensed facilities are required to renew their registrations annually if they intend to continue to work with our drug. The DEA conducts periodic inspections of certain registered establishments that handle controlled substances. We are choosingplanning to “opt out” of this provisionwork with our manufacturers, distributors, exporters and clinical sites to obtain the necessary licenses.

Individual states have also established controlled substance laws and regulations. Though state-controlled substances laws often mirror federal law, because the states are separate jurisdictions, they may separately schedule drugs, as well. While some states automatically schedule a drug based on federal action, other states schedule drugs through rulemaking or a legislative action. The requirement for state registrations could also result we will comply with new or revised accounting standards as required when they are adopted. This decision to opt outin delay of the extended transition period is irrevocable.

Properties

We currently do not rent any real property or offices. Our current business address is 32932 Pacific Coast Highway, #14-254, Dana Point, California 92629.

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. Except as noted below, 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 its resultsour business, financial condition or operating result.

There are no material proceedings in which any of operations, financial positionour directors, officers or cash flow.

The following table sets forth information regarding our executive officers and the names and agesmembers of our current directors and executive officers, the principal offices and positions held by each person:

Family Relationships

There are no family relationships betweenamong any of our directorsofficers or executive officers andofficers.

Independent Directors

We currently do not have any otherindependent directors or executive officers.

Committees of the Board of Directors

We do not have an audit or compensation committee comprised of independent directors, therefor the functions that would have been performed by such committees are performed by our director.directors. The Board of Directors has not established an audit committee and does not have an audit committee financial expert, nor has the Board of Directors established a nominating committee. The Board is of the opinion that such committees are not necessary since the Company is an early development stage company and has only two directors, and to date, such director hasdirectors have been performing the functions of such committees. Thus, there is a potential conflict of interest in that our directordirectors and officer hasofficers have the authority to determine issues concerning management compensation, nominations, and audit issues that may affect management decisions.

Code of any other conflicts of interest of our executive officer and director.

We currently subject to a pending a criminal proceeding (excluding traffic violations and other minor offenses); (ii) been a party to a civil proceeding of a judicial or administrative body of competent jurisdiction and as a result of such proceeding was or is subject to a judgment, decree or final order enjoining future violations of, or prohibiting or mandating activities subject to any federal or state securities or banking or commodities laws including, without limitation, in any way limiting involvement in any business activity, or finding any violation with respect to such law, nor (iii) any bankruptcy petition been filed by or against the business of which such person was an executive officer or a general partner, whether at the time of the bankruptcy or for the two years prior thereto.