As filed with the Securities and Exchange Commission on September 27, 2021.July 22, 2022

Registration No. 333-255022

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM S-1/A

(Amendment No. 1)2)

REGISTRATION STATEMENT

UNDER THE SECURITIES ACT OF 1933

RAPID THERAPEUTIC SCIENCE

LABORATORIES, INC.

(Exact name of registrant as specified in its charter)

15800 Dooley Road,5580 Peterson Lane, Suite 200120

Addison,Dallas, Texas 7500175201

(800) 497-6059

(Address, including zip code, and telephone number,

including area code, of registrant’s principal executive offices)

Donal R. Schmidt, Jr., Chief Executive Officer

Rapid Therapeutic Science Laboratories, Inc.

15800 Dooley Road,5580 Peterson Lane, Suite 200 | Addison,120

Dallas, Texas 7500175201

(800) 497-6059

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

including area code, of agent for service of process)

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Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: [X]☐

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

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

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

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

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act. [  ]

CALCULATION OF REGISTRATION FEE

(1)Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) of the Securities Act of 1933, as amended (the “Securities Act☐”). 

(2)Includes common stock and/or warrants that may be issued upon exercise of a 45-day option granted to the underwriters to cover over-allotments, if any. 

(3)In accordance with Rule 457(g) under the Securities Act, because the shares of the common stock underlying the warrants are registered hereby, no separate registration fee is required with respect to the warrants registered hereby. 

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(4)There will be issued one warrant to purchase one share of common stock for every unit offered. The warrants are exercisable at a per share price of ______% of the unit public offering price. 

(5)Represents warrants granted to the representative of the underwriters to purchase shares of common stock in an amount up to 5.0% of the number of shares of common stock sold to the public in this offering. Also includes warrants that may be granted if the underwriters exercise their over-allotment option in full. See “Underwriting” contained within the prospectus included in this registration statement. No registration fee pursuant to Rule 457(g) under the Securities Act. 

(6)Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) under the Securities Act based on an estimate of the proposed maximum aggregate offering price. The representative’s warrants are exercisable at a per share exercise price equal to 120% of the public offering price of the units. As estimated solely for the purposes of calculating the registration fee pursuant to Rule 457(g) of the Securities Act, the proposed maximum offering price of the representative’s warrants is equal to 120% of $575,000 (5.0% of $11,500,000). 

(7)Previously paid. 

In the event of a stock split, stock dividend, or similar transaction involving the common stock, the number of shares registered shall automatically be increased to cover the additional shares of common stock issuable pursuant to Rule 416 under the Securities Act.

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

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

PRELIMINARY PROSPECTUS SUBJECT TO COMPLETION, DATED SEPTEMBER [—], 2021JULY 22, 2022

RAPID THERAPEUTIC SCIENCE LABORATORIES, INC.

Units

Each Unit Consisting of

One Share of Common Stock

and

One Warrant to Purchase One Share of Common Stock

We are offering up to _____________ Units at an assumed offering price of $______ per Unit, which was the last reported sale price of our common stock on the OTC Pink Market, operated by OTC Markets Group Inc., on SeptemberJuly ___, 2021,2022, with each Unit consisting of one share of common stock, $0.001 par value per share, and one warrant to purchase one share of common stock, of Rapid Therapeutic Science Laboratories, Inc., a Nevada corporation (the “Registrant”, “Rapid” or the “Company”) in a firm commitment underwritten public offering. Each warrant is immediately exercisable for one share of common stock at an exercise price of $______ per share (or _____% of the price of each Unit sold in the offering) and will expire five years from the date of issuance. The Units will not be certificated and the shares of common stock and the warrants comprising such Units are immediately separable and will be issued separately in this offering.

Our common stock is presently quoted on the OTC Pink Market, operated by OTC Markets Group Inc., under the symbol “RTSL”. At present, there is a limited market for our common stock. There is no established trading market for the warrants. We plan to applyhave applied to list our common stock and the warrants on the Nasdaq Capital Market under the symbols “RTSL” and “RTSL WS”, respectively, simultaneously with the closing of this offering.respectively. We believe that upon the completion of the offering contemplated by this prospectus, we will meet the standards for listing on the Nasdaq Capital Market. We cannot guarantee that we will be successful in listing our common stock or warrants on the Nasdaq Capital Market; however, we will not complete this offering unless we are so listed.

On September [____], 2021,July 21, 2022, the last reported sale price for our common stock on the OTC Pink Market was $[_____]$2.15 per share. Quotes of stock trading prices on an over-the-counter marketplace may not be indicative of the market price on a national securities exchange.

The assumed offering price used throughout this prospectus has been included for illustration purposes only. The actual offering price may differ materially from the assumed price used in the prospectus and will be determined by negotiations between us and the representatives of the underwriters and may not be indicative of prices that will prevail in the trading market.

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Effective on December 29, 2020, our Board of Directors, and effective on December 30, 2020, stockholdersJanuary 11, 2022, shareholders holding a majority of our outstanding voting shares approved resolutions authorizing(collectively, the “Majority Shareholders”), representing an aggregate of 51.4% of the total voting shares as of such date, executed a written consent in lieu of a special meeting of shareholders (the “Majority Shareholder Consent”), approving among other things, the grant of discretionary authority for our Board of Directors, without further shareholder approval, to effect a reverse stock split of all of the outstanding shares of our common stock inof the range from one-for-two (1-for-2) to one-for-twenty (1-for-20), and provided authorityCompany, by the filing of an amendment to our Board of Directors to select the ratio of the reverse stock split in their discretion. The Board of Directors anticipates setting the ratio of the reverse stock split, prior to the effective date of the registration statement (of which this prospectus forms a part). We anticipate filing Articles of Amendment to affect the reverse stock splitIncorporation with the Secretary of State of Nevada, priorin a ratio of between one-for-two and one-for-fifty, with the Company’s Board of Directors having the discretion as to whether or not the uplisting of our common stock and warrants on the Nasdaq Capital Market and such reverse stock split being effective on, or just before, the date our common stock is listed to the Nasdaq Capital Market. The reverse stock split is intended to allow usbe effected, and with the exact exchange ratio of any reverse split to meetbe set at a whole number within the minimum share price requirement of the Nasdaq Capital Market. As the ratio for the reverse stock split has not yet been approvedabove range as determined by the Board of Directors in its sole discretion, at any time before the shareearlier of (a) December 31, 2022; and per share information in this prospectus do not reflect(b) the proposed reversedate of the Company’s 2022 annual meeting of shareholders (the “Shareholder Authority”) and an amendment to our Articles of Incorporation to increase the number of our authorized shares of common stock from 750,000,000 to 800,000,000 (the “Authorized Share Increase”).

On March 4, 2022, the Board of Directors approved a stock split ratio of 1-for-25 (“Reverse Stock Split”) in connection with the Shareholder Authority, provided that such approval was subject in all cases to approval of such Reverse Stock Split by the Financial Industry Regulatory Authority (FINRA), and the filing of an amendment to the Articles of Incorporation of the authorized and outstanding common stock which is anticipated to occur immediately priorCompany with the Secretary of State of Nevada. On March 29, 2022, the Company filed a Certificate of Amendment to the closingCompany’s Articles of Incorporation with the offering in a range as described above.Secretary of Nevada to effect the Reverse Stock Split and the Authorized Share Increase (the “Amendment”), which became effective at 2:00:01 A.M., Central Standard Time, on March 31, 2022.

Investing in our securities involves risks. You should carefully consider the “Risk Factors” starting on page 1314 of this prospectus and set forth in the documents incorporated by reference herein before making any decision to invest in our securities.

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

(1)Does not reflect additional compensation to the underwriters in the form of warrants to purchase up to shares of common stock (assuming the over-allotment option is fully exercised) at an exercise price equal to 120% of the public offering price. We have also agreed to reimburse the underwriters for certain expenses. See “Underwriting” beginning on page 7992 for a description of these arrangements. 

(2)We estimate the total expenses of this offering will be approximately $_________________. Assumes no exercise of the over-allotment option we have granted to the underwriters as described below.
 

We have granted a 45-day option to the representative of the underwriters to purchase up to an additional __________________ shares of common stock and/or warrants to purchase up to ____________ shares of common stock to cover over-allotments, if any (based on assumed offering price of $______ per Unit, which was the last reported sale price of our common stock on the OTC Pink Market, operated by OTC Markets Group Inc., on September ___, 2021)July___, 2022).

The underwriters expect to deliver our shares and warrants to purchasers in the offering on or about __________________ 2021.2022.

Maxim Group LLC

The date of this prospectus is ______________________ 2021.

2022.

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No dealer, salesperson or other individual has been authorized to give any information or to make any representation other than those contained in this prospectus in connection with the offer made by this prospectus and, if given or made, such information or representations must not be relied upon as having been authorized by us. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities in any jurisdiction in which such an offer or solicitation is not authorized or in which the person making such offer or solicitation is not qualified to do so, or to any person to whom it is unlawful to make such offer or solicitation. Neither the delivery of this prospectus nor any sale made hereunder shall, under any circumstances, create any implication that there has been no change in our affairs or that information contained herein is correct as of any time subsequent to the date hereof.

For investors outside the United States: We have not done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves, and observe any restrictions relating to, the offering of our Units and the distribution of this prospectus outside the United States.

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ABOUT THIS PROSPECTUS

This prospectus is part of a registration statement that we filed with the Securities and Exchange Commission (the “SEC” or the “Commission”).

Certain cannabinoid industry terms used in this prospectus are defined in the “Glossary of Cannabinoid Industry Terms” in Annex A of this prospectus.

You should read this prospectus, together with additional information described under “Where You Can Find More Information”, beginning on page 90,103, before making an investment decision.

On February 16, 2021, our Board of Directors approved a change in our fiscal year end from March 31 to December 31. As such, the financial information and certain of the other disclosures herein, where indicated, are presented for the nine-month transition period ended December 31, 2020, for the fiscal year ended December 31, 2021, and the three months ended March 31, 2020,2022 and for the three and six months ended June 30, 2021.

This prospectus does not contain all the information provided in the registration statement we filed with the SEC. For further information about us or our securities offered hereby, you should refer to that registration statement, which you can obtain from the SEC as described below under “Where You Can Find More Information”, beginning on page 90.103.

We will disclose any material changes in our affairs in a post-effective amendment to the registration statement of which this prospectus is a part, or a prospectus supplement. We do not imply or represent by delivering this prospectus that Rapid Therapeutic Science Laboratories, Inc., or its business, financial condition or results of operations, are unchanged after the date on the front of this prospectus is correct at any time after such date, provided that we will amend or supplement this prospectus to disclose any material events which occur after the date of such prospectus to the extent required by applicable law.

Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities and the distribution of this prospectus outside of the United States.

Our logo and some of our trademarks and tradenames are used in this prospectus. This prospectus also includes trademarks, tradenames and service marks that are the property of others. Solely for convenience, trademarks, tradenames and service marks referred to in this prospectus may appear without the ®, ™ and SM symbols. References to our trademarks, tradenames and service marks are not intended to indicate in any way that we will not assert to the fullest extent under applicable law our rights or the rights of the applicable licensors if any, nor that respective owners to other intellectual property rights will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

The market data and certain other statistical information used throughout this prospectus are based on independent industry publications, reports by market research firms or other independent sources that we believe to be reliable sources. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. We are responsible for all of the disclosures contained in this prospectus, and we believe these industry publications and third-party research, surveys and studies are reliable. While we are not aware of any misstatements regarding any third party information presented in this prospectus, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors, including those discussed under the section entitled “Risk Factors” beginning on page 1314 of this prospectus. These and other factors could cause our future performance to differ materially from our assumptions and estimates. Some market and other data included herein, as well as the data of competitors as they relate to Rapid Therapeutic Science Laboratories, Inc., is also based on our good faith estimates.

Unless the context otherwise requires, references in this prospectus to “we,” “us,” “our,” the “Registrant”, the “Company,” “Rapid” and “Rapid Therapeutic Science Laboratories” refer to Rapid Therapeutic Science Laboratories, Inc. and its subsidiaries.

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In addition, unless the context otherwise requires:

·“Exchange Act” refers to the Securities Exchange Act of 1934, as amended; 

·“SEC” or the “Commission” refers to the United States Securities and Exchange Commission; and 

·“Securities Act” refers to the Securities Act of 1933, as amended. 

All dollar amounts in this prospectus are in U.S. dollars unless otherwise stated. You should read the entire prospectus before making an investment decision to purchase our securities.

CAUTIONARY STATEMENT REGARDING FORWARD LOOKING STATEMENTS

This prospectus, each prospectus supplement and the information incorporated by reference in this prospectus and each prospectus supplement contain certain statements that constitute “forward looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act and Section 21E of the Securities Exchange Act. The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” and the negative and plural forms of these words and similar expressions are intended to identify forward looking statements, but are not the exclusive means of identifying such statements. Those statements appear in this prospectus, any accompanying prospectus supplement and the documents incorporated herein and therein by reference, particularly in the sections titled “Prospectus Summary” and “Risk Factors,” and include statements regarding the intent, belief or current expectations of the Company and management that are subject to known and unknown risks, uncertainties and assumptions. Examples of forward-looking statements include statements relating to macroeconomic conditions; our expectations regarding future growth, including future revenue and earnings increases; our expectations regarding new products and market acceptance of current and new products; anticipated changes in regulations and market acceptance of our products and industry; our growth plans and opportunities, including our strategies for future acquisitions, future product expansion, potential client marketing and targeting and potential geographic expansion; estimated returns on future acquisitions; and other statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, capital expenditures, financing needs, the competitive landscape for our products, plans or intentions relating to acquisitions and developments and other information that is not historical information, and our assumptions underlying these expectations.

This prospectus, any prospectus supplement and the information incorporated by reference in this prospectus and any prospectus supplement also contain statements that are based on the current expectations of our Company and management. You are cautioned that any such forward looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements as a result of various factors.

Because forward looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely upon forward looking statements as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we do not plan to publicly update or revise any forward-looking statements contained herein after we distribute this prospectus, whether as a result of any new information, future events or otherwise.

You should also consider carefully the statements under “Risk Factors” and other sections of this prospectus, which address additional facts that could cause our actual results to differ from those set forth in the forward-looking statements. We caution investors not to place significant reliance on the forward-looking statements contained in this prospectus.

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PROSPECTUS SUMMARY

The following summary highlights material information found in more detail elsewhere in the prospectus. It does not contain all of the information you should consider. As such, before you decide to buy our common stock and warrants, in addition to the following summary, we urge you to carefully read the entire prospectus, especially the risks of investing in our common stock and warrants as discussed under “Risk Factors.”

About Rapid Therapeutic Science Laboratories, Inc.

We are aan biotech company specializing in natural relief through aerosol delivery of non-psychoactive cannabinoids (NPC)² to the blood stream though the pulmonary route of administration.delivery. We were founded to research and develop pharmaceutical biologics and identify new ways to leverage applied aerosol devices known as pressurized meter dose inhalers, otherwise referredtechnology. Our plans for our initial entry into this space is to as pMDI or just MDI, in our daily lives, which create an effective delivery systems for many typesnon-psychoactive cannabinoids (NPCs).

The Company commenced limited sales of phytocannabinoids (cannabinoids that occur naturallyits inhaler products to customers, while still in a product development mode, on a trial basis beginning in January 2020; however, due to the subsequent impact of the COVID-19 pandemic, as well as other contributing factors, the Company has currently suspended such sales. The Company is not currently manufacturing or selling any products, and has generated only nominal revenues since January 1, 2021. Moving forward, funding permitting, and upon obtaining any necessary governmental and/or third party approvals, the Company plans to build out its 8,566 square feet of leased commercial office building space located in Addison, Texas, with the intention of utilizing it as its corporate office as well as its aerosol filling laboratories and isolate manufacturing facility, beginning in the hemp plant). Thethird quarter of 2022. Sales to the public of MDIs are not anticipated in 2022 or 2023 because of anticipated U.S. Food and Drug Administration (FDA) testing in connection with the Company’s planned IND (Investigational New Drug Application) filing with the FDA, as discussed below. Notwithstanding that, the Company uses no THCplans to explore selling pharmaceutical isolates of cannabidiol (CBD), cannabigerol (CBG) and cannabinol (CBN), after the construction of the isolate manufacturing facility is complete and the Company is approved for manufacture in its products.connection with good manufacturing practices, otherwise known as GMP. At that time the Company plans to also consider white labeling non-MDI aerosol products such as oral, nasal or topical sprays.

WeThe Company’s founders believed that pharmaceutical biologics, including hemp phytoextracts (extracts from the hemp plant), specifically, but not limited to, NPCs, could possibly help individuals find a new way to manage or support the treatment of a variety of common patient indications. What started as an idea of using an inhaler to deliver a potential pain reliever CBD, which is an active ingredient in cannabis derived from the hemp plant), has grown into a company that, funding permitting and subject to receiving any necessary governmental and/or third party approvals, plans in the future to produce many different NPCs and/or blends thereof to ,be safely, efficiently, and cost effectively, delivered to consumers using aerosol delivery devices. None of the Company’s products use THC.

In our experience, new and effective delivery systems for active pharmaceutical ingredients (“API”) or supplements have been a growth engine for brands and companies.  In this vein, we believe that providing consumers with safer, faster and more efficient ways to deliver NPCs will drive the growth of our business.

The Company intends to maintain the highest level of quality and compliance in our formulations and manufacturing practices.  To this end, we plan to seek to gain FDA approval of our devices prior to manufacturing and selling these products.  When we begin manufacturing our products, we intend to use what we believe are the highest quality ingredients and manufacturing practices to ensure consumers get the purest possible product that is produced according to good manufacturing practices, otherwise known as GMP. The Company recognized very early that aerosol manufacturing, in combination with new unique proprietary technology and formulations, would meet the needs of consumers looking for a better way to utilize hemp products.

OurAny product lines we develop will focus on safe, legal and effective active pharmaceutical ingredients (“API”).API. The Company exclusively uses APIs consisting of our proprietary blend of isolate (crystalline solid or powder) derived NPCs. We have named our NPC blend N-Psican^TM. As a result of a recentlyvertical acquisition completed vertical acquisition,in 2021, we own the process and extraction method we believe will result in the highest pharmaceutical grade NPCs available now and in the future. This ability to source, manufacture and sustain our own API ingredients is expected to result in lowering costs and providing a consistent and measured dose for

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consumers. In addition, we anticipate that this will allow for a higher degree of safety because we will control the entire manufacturing process.

WeAs such, we now have the capacity to manufacture and use our own pharmaceutical grade NPCs, which areNPCs. We expect these products will be ultra-pure and unadulterated and are planned to be manufactured using our own NPCs derived from our proprietary processes which we control quality and purity of to an extreme degree, and which we plan to take steps to patent.

Using our own NPCs as the API. WeAPI, we are aiming to manufacture our own branded MDI under the nhāler^TM brand name (we(provided that we have removed all of our MDInhāler products from the market because we are preparing to file ana IND (Investigational New Drug Application) with the FDA)FDA in connection therewith) using our proprietary blends. Using our own NPCs derived from our proprietary processes, weand their substrates are able to control the qualitylegal for manufacturing and purity of our products to an extreme degree, which we plan to take steps to patent.human consumption in Texas under House Bill 1325 (discussed below). None of our products contain any psychoactive cannabinoids or tetrahydrocannabinol (THC) compounds of any amount.

The Company believes it is unique in the emerging hemp industry in that it does not use “full spectrum” oil, nor does it use compressed air as a propellant. Full spectrum oil is an industry term that means the composite hemp plant crude extract has been liquified using a solvent. The amounts and quantity of any API in full spectrum oil is not readily ascertainable, nor is the consumer usually aware of what solvents are used to liquify the extracts. Accordingly, we do not believe that it is possible to manufacture a safe MDI using full spectrum oil as the product could becomebe adulterated or even toxic, depending upon how the extracted crude is handled and prepared. Any impurity, contaminants, or solvents used in full spectrum oil can endanger a consumer and cause any number of ailments, including laryngospasms, bronchospasms, or lipoid pneumonia. The Company has identified these issues and has consistently worked to avoid any toxicity, impurities or contaminants in its products.

In furtherance of our commitment to safety and purity, we are planning for the Company’s MDI to be made using FDA listed cans, valves, actuators, propellant and excipients following GMP. All of these parts are manufactured under GMP in accordance with each manufacturer’s requirements which are listed in master drug files with the FDA. We purchase these parts and inert ingredients directly from one or two of the largest suppliers of FDA listed consumables in the world. We also plan to only use cGMP HFA-134a propellant which is listed with the FDA and approved for humans, in our products. We believe the technology we use is safe if properly applied and has been researched over more than 70 years with hundreds of drugs.

We believe we are the only company in the world that is manufacturing an MDI with an NPC API safe for human consumption. TheWe have also hired an experienced pharmaceutical industry veteran (Dr. Duane Drinkwine, our Chief Science Officer (a non-executive)), who has years of experience with companies such as GlaxoSmithKline, Pfizer and Bayer manufacturing APIs for prescription inhalers. Dr. Drinkwine brings over a decade of isolate API production experience to the Company has test marketed its MDI products directlyand provides expertise in manufacturing, oversight of safety and compliance related to pharmacies and physicians who treat a wide range of ailments including, but not limited to, general anxiety disorder (GAD), post-traumatic stress disorder (PTSD) and pain management. During this period, we collected feedback and suggestions for product enhancement and consumer satisfaction.prescription medication.

² NPCs include, but are not limited to, cannabidiol (CBD), cannabigerol (CBG), cannabichromene (CBC), and cannabinol (CBN).

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In December of 2018, the Agriculture Improvement Act of 2018 (the “Farm Bill”) was signed into law.³ It removed hemp, defined as cannabis (Cannabis sativa L.) and derivatives of cannabis with extremely low concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC) (no more than 0.3 percent THC on a dry weight basis) from the definition of marijuana in the Controlled Substances Act (CSA)⁴. The Company uses no THC in its products. The Company is certified by the Cannabinoid MDI Certification Board (CMDICB) with respect to manufacturing of its MDI. However, our products are not approved by the United States Food and Drug Administration (FDA), or under the Federal Food, Drug, and Cosmetics Act (FFDCA). Consistent with the entire hemp space, none of our products are yet approved by the FDA or under the FFDCA.Federal Food Drug and Cosmetics Act (FFDCA). We always encourage consumers to do their own research regarding all cannabinoids and our products. We make no claims about therapeutic benefits of our products. None of our products are intended to diagnose, treat, cure or prevent any disease. We recommend any consumer to always consult a physician prior to using any cannabinoid product. Any consumer who uses hemp products might have an adverse reaction and/or a drug interaction with another medication and if so, should stop use immediately and seek appropriate medical attention. None

Early cannabinoid MDIs introduced to the marketplace and to our knowledge, those of our current competitors, can cause side effects such as irritation of the Company’s products include THC.throat, vocal cords and esophagus, which consumers have not reported in connection with our MDIs, which were previously sold primarily to the medical space prior to our decision to focus on FDA approved products.

Our Products

We offer MDIs as our primary product. MDIs are devicesFrom day one we placed great emphasis on manufacturing a product that deliver a measured amount of aerosolized inhalant in a mist to the lungs that is usually self-administeredmeets cGMP. “cGMP” means current good manufacturing practice regulations promulgated by the user via inhalation. As secondary products, we plan to offer a sublingual oral spray device and water-soluble CBD and CBG isolates. To date, we have substantially completed our market research related toFDA under the release of two sublingual sprays. The Company has decided upon a brand, “ Yoka ”, as the name of a complete line of sublingual sprays. The Company intends to file for trademark protectionauthority of the brand name “ Yoka ” inFFDCA. These regulations, which have the future. The website for the Company is liveforce of law, require that manufacturers, processors, and is being constantly updatedpackagers of drugs, medical devices, some food, and the associated website for sale of the “ Yoka ” brand is being developed and is expectedblood take proactive steps to be live in the 4 ^th Quarter of 2021. The necessary consumables for sale of theseensure that their products are in stocksafe, pure, and are being readied for filling and delivery. The Company expects full scale marketing and sales of this brand will commence in October 2021.

Our MDIs contain an API of a proprietary NPC isolate including, but not limited to, CBD and/or CBG. The products are sold under the nhāler ^TM brand name (provided that we have removed those products from the market because we are preparing to file an IND (Investigational New Drug Application) with the FDA in connection therewith) and provides:

·100 metered doses. 

·5mg of our proprietary API pure cannabinoid isolate blend of NPC known as N-Psican^TM. 

·500mg of API per MDI. 

·Zero THC. 

The API is delivered to a user in a mist via inhalation. The droplet size of the liquid solution in the mist is engineered through a proprietary process to be of a size that the individual droplet can be absorbed directly into the blood stream through the cellular wall of the alveoli (the tiny air sacs of the lungs) and its surrounding blood vessels.effective. This process is known as the pulmonary route of administration. If the droplet size is too large to enter the alveoli, it is considered topical in nature and is of lower bioavailability and efficacy. If the droplet size is too small, the droplet is not heavy or dense enough to be absorbed and will be exhaled, thereby lowering bioavailability and efficacy. As such, the proprietary knowledge needed to engineer an appropriate droplet size is crucial to manufacturing an effective MDI.

Our cans, valves, actuators and filling equipment are all on file with the FDA. We comply with all GMP requirements followed by the manufacturers of our consumables and equipment, except for the API. Our pharmaceutical grade propellant and CBD isolate are considered non-toxic by the FDA.⁵ We use a small amount of medical inhalation grade ethanol. Additionally, with our MDI, there is no smell and it will keep working even if submerged in water.

³ P.L. 115-334

⁴ At all instances throughout this Prospectus, the Company uses “hemp extracts” as “hemp” is defined under Federal Regulation. Non-THC cannabis is used herein under the term “hemp”.

⁵ The FDA has not approved our isolate for use in humans. However, there are no reports of toxicity at the dosage we manufacture in the scientific literature.

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Our recently introduced sublingual oral spray device (whichgoal of being fully compliant is applied viabeing pursued at a spray into the mouth) utilizes essentially the same manufacturing technologyhigh rate and equipment that is used inwe apply appropriate measures to reduce risk of non-compliance.  We are currently constructing our MDIs. However, for those users who would prefer oral or sublingual routes of administration, it delivers a uniform mist of a consistent dosage inside the mouth, which is easily absorbed in the tissues of the mouthnew filling and gums or swallowed. We developed this new product through our own recent research efforts as a way to eliminate potential discomfort associated with the delivery of pharmaceutical grade isolate through an inhaler.  Our sublingual spray is currently available for sale to the public.

Our proprietary pharmaceutical isolate is available to be purchased by manufacturers of non-competing products lines that use CBD.production facility.

Our Competitive Strengths

We believe our business has, and our future success will be driven by, the following competitive strengths:

·EmphasisPursuing FDA Approval for our Proposed Products. The Company has engaged multiple consultants to assist with this process. In addition, these consultants are overseeing implementation of the Company’s quality control system in both manufacturing of MDI and production of isolates, and our continued effort of moving towards certified laboratories. The Company is not aware of any other companies in our industry pursuing the same business strategy. 

·IND Testing and Trial. The Company has begun the process of producing all studies and research required to file an IND with the FDA. These studies include and are not limited to: sustainability profiles, pharmacokinetic (PK), chemistry, manufacturing and controls (CMC), studies, safety and toxicity, and have the means to conduct clinical trials.  

·Emphasis on Precision, Quality and Consistency in our Manufacturing. While we believe most companies in the space have focused on getting low-cost low quality CBD products to market in an effort to turn a quick profit, our focus has been on our science and manufacturing practices. We builtpreviously occupied ISO 6 and 7 control rooms on a leased basis to ensure our manufacturing practices, product development and safety protocol all follow GMP. Our acquisition of assets from Razor Jacket, LLC (“ Razor Jacket ”, as discussed below) ensures that our products will contain some of what we believenew facility, under construction, is expected to beprovide us the highest quality NPC APIs available in the CBD and hemp market places.ability to continue this emphasis. 

·Differentiated Business Model. In our experience, most companies in the cannabinoid industry only focus on direct to consumer and potentially store/dispensary sales. We have built our business more in line with those of true pharmaceutical and consumer product brands.  Our plan is to focus our MDI sales efforts on direct sales models, such as(after approval by the following:  

-Doctor Detailing

-Healthcare Group and Clinic Direct Sales

-Traditional Retail Sales

-Direct to Consumer (with professional recommendation)

As an aerosol business, we also have plans to extend our product lines to leverage other “safe for inhalation” APIsFDA) in the future. We expect that this ability to provide a new, better delivery system to established supplements and medications will drive our growth.line with pharmaceutical industry standards. 

·Superior Delivery System with Proven Efficacy History. MDIs have been in use for over 70 years and we believe they are the best way to get safe-to-usesafe to use inhalants into a user’s blood stream outside of an IV.  We have spent substantial time and resources perfecting the technology to ensure that our devices operate as designed. This involves ensuring the parts and machines are pharmaceutical grade, our lab is up to GMP standards, our dosing is accurate and measured and we believe that our API are the highest medical quality. In short, the MDI we buildare planning to manufacture are believed to be safe and unadulterated. 

·Proprietary Active Pharmaceutical Ingredients (API). The acquisition of assets from Razor Jacket allows the Company We plan to bring the production of medicalproduce our own in-house pharmaceutical grade API production in-house. Our now in-house production of isolate which was developed by experienced industry professions exclusively for MDI use. 

·Long Term Supplier Relationships. We are invested in long term relationships with our pharmaceutical providers for cans, valves, actuators and technical equipment. This allows us to be able to expand our manufacturing capacity quickly and scale up to meet customer demand.   

·Market Knowledge and Understanding. With over 30 years combined experience in the development of NPC API, our team has a high level of industry knowledge.  Our team has vast experience and extensive industry contacts to assist in the procurement of raw materials in the hemp

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space.  Our leadership team has experience building, scaling and taking businesses public.  We also have extensive technical expertise in the manufacturing of API and metered dose inhalers. In addition, we are experienced in consumer deliverables and training.

·Pursuing FDA Approval. The Company has engaged multiple consultants to assist with this process. In addition, these consultants are overseeing implementationTable of the Company’s quality control system in both manufacturing of MDI and production of isolates, in our continued effort of moving towards certified laboratories. The Company is not aware of any other companies in our industry pursuing the same business strategy.  Contents

·Clinical Trials. The Company has begun the process of clinic trials of its MDI. It will be testing the product’s effects related to pain, PTSD, anxiety, insomnia, inflammation, and recovery related to long term effects of COVID-19. 

Competitive Landscape

The Company believes its MDI is unmatched in the current CBD product marketplace. TheWe believe that the combination of our proprietary NPC API and our unique MDI delivery system create a suite of products that are highly differentiated from any other product on the market. To our knowledge, at the current time, we do not have any direct competitors who offer the same type of product.

However, there are other so-called cannabinoid inhalers offered in the marketplace, and there is an abundance of other cannabinoid products available. We face competition from manufacturers of other cannabinoid inhalers.

TheWe believe the market for the sale of CBD and other non-THC-based cannabis products is fragmented and intensely competitive. We plan to compete based upon the quality of our products and method of delivery, and eventually on our brand name recognition. We expect that the quantity and composition of the competitive environment will continue to evolve as the industry matures and new customers enter the marketplace.

We believe there is a Dry Powder Inhaler (DPI) of CBD currently in Phase 1 testing with the FDA (see “GlossaryofCannabinoidIndustryTerms” in Annex A of this prospectus for more information regarding the different phases of testing). A DPI may have some advantages and/or disadvantages when compared to a MDI, as both are inhaled products. Although we consider this device to be a competitor, we believe our device is superior based upon our discussions with industry experts and consultants. We also believe that the FDA acceptance of a DPI for Phase 1 testing may increase the chances of the FDA approving our planned IND for our CBD MDI.

CBD Industry Market Overview

According to a report published in February 2021, entitled Cannabidiol Market Size Worth $13.4 Billion By 2028, “[t]he global cannabidiol market is expected to reach $13.4 billion by 2028, according to Grand View Research, Inc. The market is expected to expand at a CAGR of 21.2% from 2021 to 2028.” The Company operates in the cannabidiol market (which includes edibles, inhalants such as vapes, topical and sublingual products - we compete against the makers of all products other than topical products), marketing its pMDIspressured MDI’s (pMDI) as a delivery method for cannabidiols. The Company competes in the market with other pMDI makers and other producers of alternative cannabidiol delivery systems, such as oral, nasal, or topical.

CBD is driving the recent hemp boom, and that trend is expected to continue for the next several years, according to the 2021 Annual Hemp & CBD Industry Factbook, published by Hemp Industry Daily (the “Factbook”). According to the Factbook, this rise is caused by an increased acceptance of CBD as a dietary supplement, as consumers are searching for products thought to boost wellness and immunity and enhance relaxation a result of COVID-19. Factbook projects that hemp’s 2020 sales of $1.9 billion will increase to $6.9 billion in 2025, a threefold increase over five years. Factbook also projects that U.S. sales of inhalable CBD (such as the MDI offered by the Company) will increase from $267 million in 2020 to $793 million in 2025 (an increase of 197%).

Our Growth Strategy

Our growth strategy is expected to build on what we believe is a superior delivery system that delivers a superior API, that together increases performance and safety of our products.  We plan on growing our business in threesix main ways:

·Capturing market share in the hemp space.  Via our MDI devices that deliver a measured amount of aerosolized inhalant in a mist to the lungs, we believe our product offering providesproducts (which we plan to begin manufacturing assuming we receive FDA approval), provide a faster acting, more accurate dosing and higher value bioavailability of our ingredients for our customers.

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As a result, we believe that we will be able to increase our consumer base and to provide top line growth for our planned retail and clinic customers.

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·Increasing penetration of hemp user. There is a decreasing stigma around the use of hemp products as a result of legalization,legal, regulatory oversight and social views that hemp products are not associated with marijuana. These views are rapidly evolving in favor of hemp being a mainstream drug or supplement.evolving. However, there are still some people and physicians unwilling to use these products, which we believe is largely based on the inability to achieve accurate and controlled dosing. Our product lines are anticipated to be meticulously manufactured to ensure an accurate and measured dose with every actuation. We believe that this will allow us to provide consumers and medical practitioners with the peace of mind that they can utilize our products safely and effectively and thus bring new consumers into the category.  

·Expand our product portfolio. We plan to grow our product portfolio by expanding into areas of other “safewhere we can identify “safe for inhalation” non-THC ingredientsinhalation” pharmaceutical biologics which are currently being used in less efficacious delivery methods and put them into our delivery device. 

·Cannabinoids, the FDA, and Clinical Testing. The cannabinoid and hemp marketplace are still somewhat devoid of medical substantiation.  There have been very few products that have started to undergo medical testing in the hopes of gaining information around benefits, dosing and potential FDA approval. Our initial goal iswas to start to explore the medical opportunity by conducting voluntary clinical testing on our nhāler^TM branded products. We have partnered with a healthcare group who has a captive patient population to test our nhāler^TM brand with patients presenting with clinical diagnosis around pain, anxiety, PTSD, insomnia and long haul COVID-19 problems. This testing is schedulednow indeterminate as we are planning to start as soon as theseek FDA approves the Company’s IND application.approval and such testing will fall under our proposed IND. In addition to clinical testing, we have engaged with a groupseveral of FDA consultants to help us position our manufacturing and formulations with the future goal of filing an INDa New Drug Application (NDA) with the FDA. We have removed ourproducts sold under the nhāler productsbrand name from the market because we are preparing to file anthis IND (Investigational New Drug Application) with the FDA. We have hired a law firm to prepareassist in preparation of the application and have further hired a lobbying firm located in Washington, D.C. to interface with the FDA on our behalf in the U.S. Congress. We are currently in discussions with other organizations with significant FDA regulatory experience to provide oversight of the entire process. These discussions are ongoing and will be finalized assuming we receive necessary funding. The Company is presently intending to conduct a pre-IND meeting with the FDA prior to filing the actual IND application with the FDA. The Company believes the pre-IND meeting and the IND application will occur in the fourththird quarter of 2021.2022, funding permitting. We anticipate, based upon discussions with outside consultants, an approximate 18-24-month time frame for FDA approval of our CBD MDI, provided some timeframe may be longer and we may never obtain FDA approval for any of our products.  

·Legal Status. Our products are not FDA approved. However, we plan to file an IND with the FDA in the fourththird quarter of 20212022 to conduct Phase I1 human clinical trials of our flagship metered dose inhaler containing CBD. We anticipate, based upon discussions with outside consultants, an approximate 18-24-month time frame for FDA approval of our CBD MDI, provided some timeframe may be longer and we may never obtain FDA approval for any of our products. CBD is considered to be a drug by the FDA and no CBD product, except one prescription product, is approved by the FDA for use in humans. Nevertheless, the FDA generally has not interfered in the commercial sale of CBD products to the public unless a manufacturer or marketer of such products make therapeutic or false claims about their products. This position has been publicly stated by the FDA in writing. WeAs such, we make no therapeutic claims pertaining to our products.whatsoever. In addition, the FDA does not consider CBD to be a dietary substance soand presently it may not be labeled as such. Finally, our MDI is considered a class II medical device and the FDA considers such devices, when not properly manufactured or if adulterated, to be potentially dangerous to the public at large. There are currently ongoing discussions about CBD and cannabinoids with Congress whichthat may impact the Company’s business operations in unexpected ways.both positively and negatively. 

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·International Expansion. We plan to eventually seek to expand our marketing and sales to outside of the United States, potentially beginning at the end of 2021, funding permitting, and assuming further declines in the spread of COVID-19. Similar to the growth trends that we are seeing in the U.S., we believe there will be a significant opportunity for us to capture market share internationally with our product offerings.offerings in the future. We have no current time predictions for this activity because we believe our best opportunity in this area is after FDA approval, as discussed above. Once we finish construction of our isolate manufacturing facility, we can, if we choose, begin to market internationally for pharmaceutical grades isolate sales. We expect this to occur by the end of 2022; however, we do not intend to market our MDI internationally until the end of our planned Phase 1 studies, because we understand and believe that the FDA has a major effect on drug sales in all foreign jurisdictions we presently have under consideration.  

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Novel Coronavirus (COVID-19)Plan to Restart Manufacturing

In December 2019, a novel strain of coronavirus, which causes the infectious disease known as COVID-19, was reported in Wuhan, China. The World Health Organization declared COVID-19 a “Public Health Emergency of International Concern” on January 30, 2020 and a “global pandemic” on March 11, 2020. In March and April 2020, many U.S. states and local jurisdictions began issuing “stay-at-home” orders. The Company has recently adopted a new business strategy focused on developing potential commercial opportunities, which will involve the rapid application of therapeutics using proprietary metered dose inhaler technology. This strategy includes typical pharmaceutical type marketing efforts (e.g., marketing directly to doctors) that has been shown to work with traditional drug product type sales, versus novelty type sales, which currently include cannabidiols. We are planningcurrently in the process of building our own manufacturing and extraction facility. This facility will provide us increased capacity for research and development and eventually manufacturing of our product lines. This facility is expected to be completed and operational in late 2022. We previously leased an ISO rated laboratory. We have paused the production of products since December 31, 2021, and plan to resume the production of products for testing purposes in the fall of 2022. Timing related to sale of MDI products will be wholly dependent on moving away from traditional internet sales and marketing, and believe this transitionFDA approvals anticipated in late 2023 or 2024, but which timing will benefit the Company going forward. COVID-19 forced the Company to temporarily suspend its marketingbe based on numerous factors, including available funding. Notwithstanding our plans as discussed above, we believe that production of pharmaceutical grade isolate can be resumed upon completion of the Company was not able to travel to meet with doctors directly; however, COVID-19 restrictionsmanufacturing laboratory which is presently about 70% complete. We have now been eased, soaccepted delivery of the Company has resumed its marketing plans. Moving forward, in the event the coronavirus pandemic continues, the range of possible impacts on the Company’s business include: (i) changing demand for the Company’s products; (ii) rising bottlenecks in the Company’s supply chain; and (iii) contraction in the capital markets.  At this time, the Company’s sales have not been materially affectedfinished clean rooms by the pandemic (asmanufacture and are awaiting a building permit from the Company has had only limited sales to date), and the Company believes that it is premature to determine the potential impact on the Company’s business prospects from these or any other factors that may be related to the coronavirus pandemic; however, it is possible that COVID-19, and the worldwide response thereto, may have a material negative effect on our operations, cash flows and resultsCity of operations.

Through the date of this Prospectus, we have been able to successfully support our operations with our cash on hand, through equity sales (which have to date been completed through private offerings) and debt borrowings. Moving forward,Addison, Texas which we believe we will needis imminent, to support our operations by raising additional funding including, but not limited to, through the sale of securities in this offering and/or equity or debt, similar to our recently completed sale of a convertible debenture (as discussed below). We continue to evaluate our business operations based on new information regarding the pandemic, and will make changes that we consider necessary in light of any developments.

The future impact of COVID-19 on our business and operations is unknown. The pandemic is continuously evolving and the full extent to which COVID-19 will ultimately impact us depends on future developments, including the duration and spread of the virus, as well as potential seasonality of new outbreaks and virus mutations.construction.

Summary Risk Factors

Our business is subject to numerous risks and uncertainties, including those in the section entitled “Risk Factors” and elsewhere in this prospectus. These risks include, but are not limited to, the following:

·Our history of operating losses and limited operating history;

·The fact that we are not currently manufacturing any products or generating any revenues; 

·Our need for significant additional financing to grow and expand our operations, the availability and terms of such financing, and potential dilution which may be caused by such financing, if obtained through the sale of equity or convertible securities; 

·Going concern issues raised by our independent auditor, as well as material weaknesses identified in our controls and procedures and internal control over financial reporting; 

·Risks relating to our ability to compete against competitors and successfully grow our operations; 

·Negative trends in the market for, the consumer acceptance of, and changes in public opinion associated with, cannabidiols and other cannabis-based products; 

·Scrutiny we may face due to prior changes in our business strategy and as a result of previously operating in certain scrutinized industries; 

·Risks associated with COVID-19, the spread of the virus, governmental responses thereto, and potential recessions and/or declines in economic activity and consumer spending caused thereby; 

·The potential long-term health effects associated with cannabis-based products such as cannabidiols and our other products, product recalls and product liability associated therewith; 

·Public opposition to the cannabis industry in general, and adverse changes in rules, laws and enforcement of rules and laws, which may have a negative effect on our operations and ability to operate in the cannabis industry; 

·The regulation of our operations, sales and manufacturing; 

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·Our ability to obtain and maintain required licenses and permits; 

·Our ability to legally advertise our products; 

·Claims relating to alleged violations of intellectual property rights of others and our ability to maintain our intellection property rights; 

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·Risks relating to implementing our acquisition strategies; 

·Risks associated with the costs of materials, inflation and energy costs; 

·The need for additional financing; 

·Our growth strategy and our ability to manage our growth;

·We could be subject to hackers or ransomware attacks 

·Changes in laws or regulations relating to our operations; 

·Dependence on current management;

·Material weaknesses in our internal control an procedures; 

·We could be subject to hackers or ransomware; 

·Certain anti-dilution rights associated with outstanding warrants; 

·The lack of a market for our securities and the volatility in the trading prices thereof caused thereby; 

·The concentrated ownership of our common stock;  

·Dilution caused by convertible securities and certain anti-dilution rights associated therewith; 

·The sale of our MDI and CBD (isolate, oral sprays or other products using our CBD) are regulated by the FDA. At any time the FDA could pronounce rules that could lead to our products being removed from the market; 

·Our products are currently legal under Texas law; however, Texas could move to regulate our products at any time; and 

·Other risks disclosed below under “Risk Factors”. 

Company Information

Our executive offices are located at 15800 Dooley Road,5580 Peterson Lane, Suite 200, Addison,120, Dallas, Texas 75001,75201, and our telephone number is (800) 497-6059. Our corporate website addresses are www.nhaler.com, www.rxoid.comand www.rtslco.com. Information contained on, or accessible through, our websites are not a part of, and are not incorporated by reference into, this prospectus.

Reverse Stock Split

Effective on January 11, 2022, shareholders holding a majority of our outstanding voting shares, representing an aggregate of 51.4% of the total voting shares as of such date, executed a written consent in lieu of a special meeting of shareholders, approving among other things, the grant of discretionary authority for our Board of Directors, without further shareholder approval, to effect a reverse stock split of all of the outstanding common stock of the Company, by the filing of an amendment to our Articles of Incorporation with the Secretary of State of Nevada, in a ratio of between one-for-two and one-for-fifty, with the Company’s Board of Directors having the discretion as to whether or not the reverse split is to be effected, and with the exact exchange ratio of any reverse split to be set at a whole number within the above range as determined by the Board of Directors in its sole discretion, at any time before the earlier of (a) December 31, 2022; and (b) the date of the Company’s 2022 annual meeting of shareholders  and an amendment to our Articles of Incorporation to increase the number of our authorized shares of common stock from 750,000,000 to 800,000,000.

On March 4, 2022, the Board of Directors approved a stock split ratio of 1-for-25 in connection with the Shareholder Authority, provided that such approval was subject in all cases to approval of such Reverse Stock Split by the Financial Industry Regulatory Authority (FINRA), and the filing of an amendment to the Articles of Incorporation of the Company with the Secretary of State of Nevada. On March 29, 2022, the Company filed a Certificate of Amendment to the Company’s Articles of Incorporation with the Secretary of Nevada to effect the Reverse Stock Split and the Authorized Share Increase, which became effective at 2:00:01 A.M., Central Standard Time, on March 31, 2022. The effects of the 1-for-25 Reverse Stock Split has been retroactively reflected throughout the registration statement, of which this prospectus forms a part.

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NASDAQ Listing and Reverse Stock Split

We plan to applyhave applied to list of our common stock and the warrants on the Nasdaq Capital Market. If our application to the Nasdaq Capital Market is not approved or we otherwise determine that we will not be able to secure the listing of the common stock and warrants on the Nasdaq Capital Market, we will not complete the offering.

On December 29, 2020, our Board of Directors, and on December 30, 2020, stockholders holding a majority of our outstanding voting shares, approved resolutions authorizing a reverse stock split of the outstanding shares of our common stock in the range from one-for-two (1-for-2) to one-for-twenty (1-for-20), and provided authority to our Board of Directors to select the ratio of the reverse stock split in their discretion. The Board of Directors anticipates setting the ratio of the reverse stock split, prior to the effective date of the registration statement (of which this prospectus forms a part). We anticipate filing Articles of Amendment to affect the reverse stock split with the Secretary of State of Nevada prior to the listing of our common stock and warrants on the Nasdaq Capital Market and such reverse stock split being effective on, or just before, the date our common stock and warrants are listed to the Nasdaq Capital Market. The reverse stock split is intended to allow usIn an effort to meet the required minimum sharetrading price requirement of the Nasdaq Capital Market.

As theMarket, as discussed above, on March 31, 2022, we effected a 1-for-25 reverse stock split of our outstanding common stock. Notwithstanding such reverse stock split, our common stock has not yetrecently been approved bytrading below $4.00 per share, and we believe our common stock will need to (a) maintain a bid price of at least $4.00 per share on at least 30 of the 60 trading days prior to the uplisting of our common stock on the Nasdaq Capital Market (which requirement we believe has already been met); and/or (b) have a bid price of at least $4.00 per share prior to the uplisting of our common stock on the Nasdaq Capital Market, provided that Nasdaq approves our uplisting and we meet the other required uplisting criteria. As a result, our Board of Directors may take action in the future, without shareholder approval, pursuant to the power provided to the Board of Directors by the share and per share informationNevada Revised Statutes, in this prospectus do not reflect the proposedevent they deem such action necessary, to affect an additional reverse stock split of theboth our outstanding and authorized and outstandingunissued shares of common stock, in the event the Board of Directors believes that such reverse stock split is necessary for us to meet the listing requirements of the Nasdaq Capital Market. No reverse stock split other than the 1-for-25 reverse stock split described above which is anticipatedwas effective March 31, 2022, and has been retroactively reflected throughout this prospectus, has been approved to occur immediatelydate. Any further reverse stock split will be reflected in an amendment to the registration statement of which this prospectus forms a part prior to the closingeffectiveness of the offering in a range of one-for-two (1-for-2) to one-for-twenty (1-for-20), as previously approved by our shareholders.such registration statement.

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THIS OFFERING

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Unless we indicate otherwise, all information in this prospectus:

·assume no exercise of the warrants sold in the offering as part of the Units; 

·is based on 193,541,9217,746,687 shares of common stock issued and outstanding as of September [__], 2021;July 22, 2022; 

·assumes no exercise by the representative of the underwriters of its option to purchase up to an additional ____________ shares of common stock and warrants to cover over-allotments, if any; 

·excludes 8,204,3371,280,232 shares of our common stock issuable upon the exercise of warrants with exercise prices ranging from $0.40$10.00 to $1.00$25.00 per share, with a weighted average exercise price of $12.17 per share; 

·assumes no issuance of Series A Convertible Preferred Stock (“Series A Preferred Stock”), Series B Convertible Preferred Stock (“Series B Preferred Stock”)(of which a total of 1 million shares of Series B Preferred Stock have been earned, but not issued, as of the date of this prospectus) or Series C Convertible Preferred Stock (“Series C Preferred Stock”), nor any issuance of shares of common stock upon conversion thereof; 

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·excludes shares of common stock issuable upon conversion of outstanding convertible promissory notes, of which convertible notes in the aggregate amount of approximately $2,116,000, which have conversion prices between $0.05$1.25 and $10.00 per share and $0.40;share; 

·excludes shares of common stock issuable upon conversion of antwo outstanding debenturedebentures in the total aggregate amount of approximately $1,941,176,$2,352,940, each of which has a conversion price of $0.40 per share, provided that such  

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debenture will automatically convert into common stock upon the closing of this offering, at a conversion price equal to $_______________$10.00 per share, subject to a beneficial ownership limitation of 4.99%, preventing such conversion by the applicable holder thereof, if such exercise would result in such holder and its affiliates, exceeding ownership of 4.99% of our common stock;

·assumes no further awards under the Company’s equity compensation plans; and 

·assumes no exercise of the Representative’s Warrants. 

SELECTED HISTORICAL CONSOLIDATED FINANCIAL AND OPERATING DATA

The following table presents our summary historical financial data for the periods indicated. The summary historical financial data for the nine monthsyear ended December 31, 2020 and 2019,2021, and the yearnine month transition period ended MarchDecember 31, 2020, and the balance sheet data as of December 31, 20202021 and MarchDecember 31, 2020, are derived from the audited financial statements included herein. The summary historical financial data for the sixthree months ended June 30, 2021March 31, 2022 and 2021 and the balance sheet data as of June 30, 2021,March 31, 2022, are derived from the unaudited financial statements included herein.

Historical results are included for illustrative and informational purposes only and are not necessarily indicative of results we expect in future periods, and results of interim periods are not necessarily indicative of results for the entire year. You should read the following summary financial data in conjunction with “Management’sManagement’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes appearing elsewhere in this prospectus.

Summary Statement of Operations Data

Summary Balance Sheet Data

(at (at period end)

(1)Working capital represents total current assets less total current liabilities. 

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RISK FACTORS

You should be aware that there are substantial risks for an investment in our common stock and warrants. You should carefully consider these risk factors, along with the other information included in this prospectus, before you decide to invest in our common stock and warrants.

If any of the following risks were to occur, such as our business, financial condition, results of operations or other prospects, any of these could materially affect our likelihood of success. If that happens, the market price of our common stock and warrants, if any, could decline, and prospective investors would lose all or part of their investment in our common stock.

Risks Related to Our Business

Our business, financial condition and results of operations are subject to various risks and uncertainties, including those described below and elsewhere in this prospectus. This section discusses factors that, individually or in the aggregate, we think could cause our actual results to differ materially from expected and historical results, and consequently, could cause the value of our securities (including our common stock and warrants) to decline in value. Our business, financial condition or results of operations could be materially adversely affected by any of these risks. It is not possible to predict or identify all such factors. Consequently, the following description of Risk Factors is not a complete discussion of all potential risks or uncertainties applicable to our business.

We have a history of operating losses, and we may not be able to achieve or sustain profitability; we have recently shifted to an entirely new business and may not be successful in this new business.

We are not profitable and have incurred an accumulated deficit of $10,101,174 since our inception. Our revenues from sales on a trial basis for the year ended December 31, 2021 and the nine months ended December 31, 2020, were $534 compared to $130,916, consisting mostly of two large wholesale orders, in the nine months ended December 31, 2020. We had no sales for the three months ended March 31, 2022. Sales to the public of MDIs are not anticipated in 2022 or 2023 because of anticipated FDA Regulationstesting in connection with the Company’s planned IND filing with the FDA, as discussed below. Notwithstanding that, the Company plans to explore selling pharmaceutical isolates of CBD, CBG and CBN, after the construction of the isolate manufacturing facility is complete and the Company is approved for GMP. At that time the Company plans to also consider white labeling non-MDI aerosol products such as oral, nasal or topical sprays. We expect to continue to incur losses for the foreseeable future, and these losses could increase as we continue to work to develop our business. We were previously engaged in pursuing the business of bitcoin mining and digital currency and were not successful in that business.  In November 2019, we adopted a new business strategy focused on developing potential commercial opportunities involving the rapid application of therapeutics using inhaler technology that the Company has licensed for its use. We have yet to commence profitable operations in that business and have generated only minimal revenues in connection with such new business strategy; therefore, the Company is continuing to incur operating losses. We may not generate significant revenues in the future, may not be able to sustain our operations with the revenue that we generate in the future, and even if we achieve profitability, we may not be able to sustain profitability in subsequent periods.

We are not currently manufacturing any products or generating any revenues.

The Company commenced limited sales of its inhaler products to customers, while still in a product development mode, on a trial basis beginning in January 2020; however, due to the subsequent impact of the COVID-19 pandemic, as well as other contributing factors, the Company has currently suspended such sales. Sales to the public of MDIs are not anticipated in 2022 or 2023 because of anticipated FDA testing in connection with the Company’s planned IND filing with the FDA. Notwithstanding that, the Company will explore selling pharmaceutical isolates of CBD, CBG and CBN, after the construction of the isolate manufacturing facility is complete and the Company is approved for GMP. At that time the Company will also consider white labeling non-MDI aerosol products such as oral, nasal or topical sprays. The Company is not currently manufacturing or selling any products, and has generated only nominal revenues since January 1, 2021. Moving forward, funding permitting, and upon obtaining any necessary governmental and/or third party approvals, the Company plans to build out its 8,566 square feet of leased commercial office building space located in Addison, Texas, with the intention of utilizing it as its corporate office as well as its aerosol filling laboratories and isolate manufacturing facility, beginning in the third quarter of 2022, and hopes to begin re-manufacturing and selling metered dose inhalers (MDI)

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and other products to deliver NPCs to customers for testing purposes in the third quarter of 2022, of which there can be no assurance. Because we are not currently generating any revenues, and future revenues will be subject to the filing and approval of the IND as well as other FDA approvals, discussed below, all expenses are currently being paid by borrowings and/or equity sales and such expenses will continue in the future until such time, if ever, as we can generate significant revenues. We may not be able to restart our manufacturing in the future, we may never sell any products, and we may not be able to generate sufficient revenue in the future to support our operations. We may not generate significant revenues in the future, may not be able to sustain our operations with the revenue that we generate in the future, and even if we achieve profitability, we may not be able to sustain profitability in subsequent periods.

We are subject to risks in connection with FDA Regulations.

Our MDI parts and CBD are allwill be regulated by the FDA. Prior to the removal of our MDI from the marketplace to pursue FDA approval for our MDI containing CBD, we sold our products to the public under what is commonly termed “safe harbor” provisions. These provisions essentially state that although CBD is a regulated drug under FDA rules, companies can sell to the public if they do not make any therapeutic claims and do not sell an adulterated or toxic product. We willplan to continue to sell future CBD products tointo the marketplace under this safe harbor provision; however, we will not sell a metered dose product to deliver CBD to the lungs as we are seeking FDA approval to sell this product only on an OTC or prescription bases. Regardless, at any time, the FDA could change its position and seek to remove all CBD products from the US marketplace for all manufactures.manufacturers. Based upon the stated legislative intent of the 2018 Farm Bill, our lobbyist’ advise, pending legislation in the US Congress, and on statements posted by the FDA on www.fda.gov, the Company does not expect this to happen.

Our planned FDA Investigative New Drug Application (IND) is subject to risks.

The Company has made the decision to seek approval from the FDA under what is known as an Investigative New Drug Application for its MDI containing only CBD. Although the Company is making best efforts to achieve success of an FDA approval, the IND application has not been filed to date, nor has the Company met with the FDA regarding such planned IND, and there isare no assurances the FDA will ever approve any new drug application including our MDI containing CBD. The IND application is a process to seek FDA approval of a drug for treatment of newly discovered therapeutic applications. This is a time-consuming expensive process. There is no firm timeline for how long this may take and there is no guarantee the Company will be able to meet the long-term cost of yet unknown FDA requirements. Further, there is no guarantee that at any time in the IND process the FDA will refuse to approve the application for any purpose or even allow further testing on humans. In short, the FDA could order us to stop testing at any time and to never sell the product to the public again.

We have a historyFinal approval by regulatory authorities of our products for commercial use may be delayed, limited or prevented, any of which would adversely affect our ability to generate operating losses, and we may not be able to achieve or sustain profitability; we have recently shifted to an entirely new business and may not be successful in this new business.revenues.

We aredo not profitableanticipate generating any significant operating revenue until we obtain FDA approval for our MDI products and have incurred an accumulated deficitplanned IND. We will need to successfully complete certain clinical studies and obtain regulatory approval before we begin commercial sales. We may experience unforeseen events during product development that may substantially delay or prevent product approval. The pre-clinical and clinical development, manufacturing, labeling, packaging, storage, recordkeeping, export, marketing and distribution, and other possible activities relating to our products will be subject to extensive regulation by the FDA and other regulatory agencies. Failure to comply with applicable regulatory requirements may, either before or after product approval, subject us to administrative or judicially imposed sanctions that may negatively impact the approval of $6,723,174 sinceone or more of our inception. Our revenues from sales onproducts or otherwise negatively impact our business.

Specific pre-clinical data, chemistry, manufacturing and controls data, a proposed clinical trial basisprotocol and other information must be submitted to the FDA as part of our planned IND application, and clinical trials may commence only after the IND application becomes effective. To market a new drug in the six months ended June 30, 2021, were $424 comparedUnited States, we must submit to $138,426, consisting mostlythe FDA and obtain FDA approval of two large wholesale orders, ina New Drug Application (“NDA”). An NDA must be supported by extensive clinical and pre-clinical data, as well as extensive information regarding chemistry, manufacturing and controls to demonstrate the six months ended June 30, 2020. We expect to continue to incur lossessafety and effectiveness of the drug candidate.

Obtaining approval of an NDA can be a lengthy, expensive and uncertain process. Regulatory approval of an NDA is not guaranteed. The number and types of pre-clinical studies and clinical trials that will be required for the foreseeable future, and these losses could increase as we continue to work to develop our business. We were previously engaged in pursuing the business of bitcoin mining and digital currency and were not successful in that business. In November 2019, we adopted a new business strategy focused on developing potential commercial opportunities involving the rapid application of therapeutics using inhaler technology that the Company has licensed for its use. We have yet to commence profitable operations in that business and have generated only minimal revenues in connection with such new business strategy ; therefore, the Company is continuing to incur

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operating losses. WeFDA approval varies depending on the drug candidate, the disease or condition that the drug candidate is designed to target and the regulations applicable to any particular drug candidate. Despite the time and expense exerted in pre-clinical and clinical studies, failure can occur at any stage, and we could encounter problems that delay our product candidate development or that cause us to abandon clinical trials or to repeat or perform additional pre-clinical studies and clinical trials. The FDA can delay, limit or deny approval of a drug candidate for many reasons, and product candidate development programs may not generate significant revenues in the future,be delayed or may not be ablesuccessful for many reasons including but not limited to, sustainthe following:

·the FDA or  Institutional Review Boards (“IRBs”) may not authorize us to commence, amend, or continue clinical studies; 

·we may be required to amend our operations withclinical studies in such a way that it compromises the revenuestudy data or makes the ongoing conduct of the study is impracticable; 

·there may be deviations from the clinical study protocol that we generatemay result in the future,need to drop patients from the study, increase the study enrollment size or duration, or that may compromise the reliability of the study and even if we achieve profitability, the resulting data; 

·we may not be able to sustain profitabilityenroll a sufficient number of qualified patients for clinical trials in subsequent periods.a timely manner or at all, patients may drop out of our clinical trials or be lost to follow-up at a higher rate than we anticipate, patients may not follow the clinical trial procedures, or the number of patients required for clinical trials may be larger than we anticipate; 

·we may have delays in adding new investigators or clinical trial sites, or we may experience a withdrawal of clinical trial sites; 

·the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; 

·a drug candidate may not be deemed adequately safe or effective for an intended use; 

·the FDA may not find the data from pre-clinical studies and clinical trials sufficient; 

·we may not be able to demonstrate that a product candidate provides an advantage over current standards of care or current or future competitive therapies in development; 

·to the extent that we are developing drug candidates for use in combination with other products, clinical trials may be more complex, resulting data may be more difficult to interpret, we may not be able to demonstrate that clinical trial results are attributable to our drug candidate, or developments with respect to the other product or standard of care may impact our ability to obtain product approval for our drug candidate or to successfully market our drug candidate; 

·the FDA or comparable foreign regulatory authorities may not accept data from studies with clinical trial sites in foreign countries; 

·the FDA may require that we conduct additional pre-clinical or clinical studies, change our manufacturing process, or gather additional manufacturing information above what we currently have planned for; 

·the FDA’s interpretation and our interpretation of data from pre-clinical studies and clinical trials may differ significantly; 

·the FDA may not agree with our intended indications, the design of our clinical or pre-clinical studies, or there may be a flaw in the design that does not become apparent until the studies are well advanced; 

·we may not be able to establish agreements with contractors or collaborators, including clinical trial sites and clinical contract research organizations (“CROs”), or they or we may fail to comply with applicable FDA, protocol, and other regulatory requirements, including those identified in other risk factors; 

·the FDA may not approve the manufacturing processes or facilities; 

·the FDA may change its approval policies or adopt new laws or regulations and our development program may not meet newly imposed requirements; 

·the cost of clinical trials of our product candidates may be greater than we anticipate or we may have insufficient funds for a clinical trial or to pay the substantial user fees required by the FDA upon the filing of a marketing application; or 

·the FDA may not accept an NDA or other submission due to, among other reasons, the content or formatting of the submission. 

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Our pre-clinical and clinical data, other information and procedures relating to a drug candidate may not be sufficient to support approval by the FDA or any other U.S. or foreign regulatory authority, or regulatory interpretation of these data and procedures may be unfavorable. If approved, FDA will require post-marketing studies to verify clinical benefit. Failure to conduct required post-approval studies, or confirm a clinical benefit, will allow the FDA to withdraw the drug from the market on an expedited basis.

Our business and reputation may be harmed by any failure or significant delay in receiving regulatory approval for the sale of any drugs resulting from our drug candidates. As a result, we cannot predict when or whether regulatory approval will be obtained for any drug we develop. Additionally, other factors may serve to delay, limit or prevent the final approval by regulatory authorities of our drug candidates for commercial use, including, but not limited to:

·our MDIs are in various stages of development, and we will need to conduct significant clinical testing and development work to demonstrate the quality, safety, and efficacy of these drug candidates before applications for marketing can be filed with the FDA, or with the regulatory authorities of other countries; 

·development and testing of product formulation, including identification of suitable excipients, or chemical additives intended to facilitate delivery of our drug candidates; 

·it may take us many years to complete the testing of our drug candidates, and failure can occur at any stage of this process; and 

·negative or inconclusive results, statistically or clinically insignificant results, or adverse medical events during a clinical trial could cause us to delay or terminate our development efforts. 

Significant delays relating to any preclinical or clinical trials also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do. This may prevent us from receiving marketing approvals and impair our ability to successfully commercialize our product candidates and may harm our business and results of operations. If we experience delays in obtaining approval, if we fail to obtain approval of a product candidate or if the label for a product candidate does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate, the commercial prospects for such product candidate may be harmed and our ability to generate revenues from that product candidate will be materially impaired. Accordingly, the successful development of any of our drug candidates is uncertain and, accordingly, we may never commercialize any of these drug candidates or generate significant revenue.

The FDA may determine that our drug candidates have undesirable side effects that could delay or prevent their regulatory approval or commercialization.

Undesirable side effects caused by our drug candidates could cause us, IRBs, and other reviewing entities or regulatory authorities to interrupt, delay, or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. Undesirable side effects may also result in requirements for costly post-marketing testing and surveillance, or other requirements, including risk evaluation and mitigation strategies (REMS), to monitor the safety or efficacy of the products. These could prevent us from commercializing and generating revenues from the sale of our drug candidates.

We have a limited operating history and our business is in a relatively new consumer product segment, which is difficult to forecast.

The Company has a limited operating history, which can make it difficult for investors to evaluate our operations and prospects and may increase the risks associated with investment into the Company. Our business plan is subject to all business risks associated with new business enterprises, including the absence of any significant operating history upon which to evaluate an investment. The likelihood of our success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection with the formation of a new business, the development of new strategy and the competitive environment in which the Company will operate.  It is possible that the Company will incur losses in the future.  There is no guarantee that the Company will be profitable.

Additionally, our industry segment is relatively new, and is constantly evolving.  As a result, there is a lack of available information with which to forecast industry trends or patterns.  There is no assurance that sustainable

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industry trends or preferences will develop that will lead to predictable growth or earnings forecasts for individual companies or the industry segment as a whole.  We are also unable to determine what impact future governmental regulation may have on trends and preferences or patterns within our industry segment.

We require additional financing, and we may not be able to raise funds on favorable terms or at all.

We are not currently generating any revenues and do not anticipate generating any significant revenues until late 2023 or 2024, at the earliest, pending FDA approval of our product candidates, which may not be received on a timely basis, if at all. We anticipate requiring additional fundingfurther funds in the future to grow our operations and expand ourproduce additional product lines. The sources of additional capital are expected to be from sales of our securities including equity, equity linked and convertible debt.debt and potentially notes payable. Any future sales of iyrour securities will result in dilution to existing stockholders.shareholders. Furthermore, we may incur debt in the future, and may not have sufficient funds to repay our future indebtedness or may default on our future debts, jeopardizing our business viability.

We may not be able to borrow or raise additional capital in the future, on favorable terms, if at all, to meet our needs or to otherwise provide the capital necessary to expand our operations and business, which might result in the value of our common stock and warrantssecurities decreasing in value or becoming worthless.  Additional financing may not be available to us on terms that are acceptable.  Consequently, we may not be able to proceed with our intended business plans.  Obtaining additional financing contains risks, including:

·additional equity financing may not be available to us on satisfactory terms and any equity we are able to issue could lead to dilution for current stockholders;shareholders; 

·current or future laws or regulations may make it impossible, or more difficult for the Company to raise funding, due to the fact that it operates in the cannabinoid industry; 

·loans or other debt instruments may have terms and/or conditions, such as interest rate, restrictive covenants and control or revocation provisions, which are not acceptable to management or our directors; 

·the current environment in capital markets combined with our capital constraints may prevent us from being able to obtain adequate debt financing; and 

·if we fail to obtain required additional financing to grow our business, we would need to delay or scale back our business plan, reduce our operating costs, or reduce our headcount, each of which would have a material adverse effect on our business, future prospects, and financial condition. 

Additionally, we may have difficulty obtaining additional funding, and we may have to accept terms that would adversely affect our stockholders.shareholders.  For example, the terms of any future financings may impose restrictions on our right to declare dividends or on the manner in which we conduct our business.  Additionally, lending institutions or private investors may impose restrictions on a future decision by us to make capital expenditures, acquisitions or significant asset sales.  If we are unable to raise additional funds, we may be forced to curtail or even abandon our business plan.

Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.

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Our historical financial statements have been prepared under the assumption that we will continue as a going concern. Our independent registered public accounting firm has issued reportsa report on our financial statements for the nine-month transition periodyear ended December 31, 2021 and the nine months ended December 31, 2020, and for the year ended March 31, 2020, that includedincludes an explanatory paragraph referring to our recurring operating losses and expressing substantial doubt in our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to obtain additional equity financing or other capital, attain further operating efficiencies, reduce expenditures, and, ultimately, generate revenue. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty. However, if adequate funds are not available to us when we need it, we will be required to curtail our operations which would, in turn, further raise substantial doubt about our ability to continue as a going concern. The doubt regarding our potential ability to continue as a going concern may adversely affect our ability to obtain new financing on reasonable terms or at all. Additionally, if we are unable to continue as a going concern, our stockholders may lose some or all of their investment in the Company.

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Because our business is dependent upon continued market acceptance by consumers, any negative trends will adversely affect our business operations.

We will be substantially dependent on continued market acceptance and proliferation of consumers of hemp-related products, includinghemp related products-including our current planned products and any new products we may offer. We believe that as hemp and hemp-derived cannabidiol becomes more accepted, the stigma associated with these sectors will diminish and as a result consumer demand will continue to grow. While we believe that the market and opportunity in the hemp space continues to grow, we cannot predict the future growth rate and size of the market. Any negative outlook on the industry will adversely affect our business operations. Additionally, the failure of the market to accept our current and any future products will have a material adverse effect on our revenues and prospects.

We may not succeed in restarting or growing our sales and creating a viable market for our products, and our failure to do so would have a material adverse effect on our business, prospects, financial condition and operating results.

We are a new business operating in a relatively new market sector. As is typical in a new and rapidly evolving industry, demand and market acceptance for recently introduced products and services are subject to a high level of uncertainty and risk. Because the market for our products is new and evolving, it is difficult to predict with any certainty the size of this market and its growth rate, if any. A market for our products may not develop and/or demand for our products may not emerge or be sustainable. If the market fails to develop, develops more slowly than expected or becomes saturated with competitors, our business, financial condition and operating results would be materially and adversely affected.

Changes in public opinion and perception could negatively affect our business operations.

Government policy changes or public opinion may also result in a significant influence over the regulation of the hemp industry in the United States or elsewhere. Public opinion and support for hemp and hemp products has traditionally been inconsistent and varies from jurisdiction to jurisdiction. While public opinion and support appears to be rising for legalizing hemp and hemp products, it remains a controversial issue subject to differing opinions surrounding the level of legalization. A negative shift in the public’s perception of hemp and hemp products in the United States or any other applicable jurisdiction could negatively affect current or future legislation or regulation.

Our change in our business strategy and name could subject us to increased SEC scrutiny.

We previously were engaged in the business of crypto-currency mining under our former corporate name. In November 2019, we adopted a new business strategy focused on developing potential commercial opportunities involving the rapid application of therapeutics using inhaler technology that the Company has licensed from a third party.  In January 2020, we changed our corporate name to more closely reflect this new business strategy.  The SEC has announced that it is scrutinizing public companies that change their name or business model in a bid to capitalize upon the hype surrounding new and emerging technologies, and has suspended trading of certain of such companies.  As a result, we could be subject to substantial SEC scrutiny that could require devotion of significant management and other resources and potentially could have an adverse impact on the trading of our stock.

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The current continued outbreak of the novel coronavirus, or COVID-19, has caused severe disruptions in the global economy and may have an adverse impact on our performance and results of operations.

The current continued outbreak of the novel coronavirus, or COVID-19, which has been declared by the World Health Organization (WHO) to be a “pandemic”, has spread across the globe and is impacting worldwide economic activity. COVID-19 has severely restricted the level of economic activity around the world. A public health epidemic, including COVID-19, or the fear of a potential pandemic, poses the risk that we or our employees, contractors, suppliers, and other partners may be prevented from conducting business activities for an indefinite period of time, and our customers may be prevented from purchasing our products, due to shutdowns, “stay at home” mandates or other preventative measures that may be requested or mandated by governmental authorities.  The governments of many countries, states, cities and other geographic regions have taken previous preventative or protective actions, such as imposing restrictions on travel and business operations and advising or requiring individuals to limit or forego their time outside of their homes.homes, the majority of which have expired to date.  Temporary closures of businesses have previously been ordered and numerous other businesses have been forced to

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temporarily close. Such actions have created a disruption in global supply chains, and adversely impacted many industries. To date, the only effect of the pandemic on our operations, which have been fairly minor, is that the pandemic prevented us from traveling to making sales calls on our primary client groups of physicians and other health and wellness providers, which has delayed our marketing plans. The continued COVID-19 outbreak could have a continued adverse impact on economic and market conditions and trigger a period of global economic slowdown, which could affect the future sales of our products, which have been minimal to date.

If the pandemic persists, closures or other restrictions on the conduct of business operations of our third-party manufacturers, suppliers or vendors could disrupt our supply chain.  Additionally, the increased global demand on shipping and transport services may cause us to experience delays in the future which could impact our ability to obtain materials or deliver our products in a timely manner.  These factors could otherwise disrupt our operations and could have an adverse effect on our business, financial condition and results of operations - whichoperations-which disruptions, as discussed above, have been only minor to date.

There is a possibility that COVID-19 will negatively affect our results of operations. If Government-mandated closures continue or increase, we may be unable to market our product as planned, which could negatively affect our revenues, growth and ability to raise capital. The global impact of COVID-19 continues to evolve rapidly, and the extent of its effect on our operational and financial performance will depend on future developments, which are highly uncertain, including the duration, scope and severity of the pandemic, the actions taken to contain or mitigate its impact, and the direct and indirect economic effects of the pandemic and related containment measures, among others.

Even after the pandemic subsides, our business could also be negatively impacted ifshould the effects of COVID-19 lead to changes in consumer behavior, including (but not limited to) as a result of a decline in discretionary spending.

Moreover, future events could cause global financial conditions to suddenly and rapidly destabilize, and governmental authorities may have limited resources to respond to such future crises.  Future crises may be precipitated by any number of causes, including natural disasters, geopolitical instability, changes to energy prices or sovereign defaults.  Any sudden or rapid destabilization of global economic conditions could negatively impact our ability to obtain equity or debt financing.  If increased levels of volatility in the business community continue including, but not limited to, short supplies of raw materials, shipping prices, or restrictions on propellants which contain propellant grade HFC 134a/P (“HFC”), or inflation increases, it would likely materially affect our business and the value of our securities. Additionally, presently, the EPA has issued a public notice regarding the use of HFC, this, but to our knowledge, no action has been taken to ban the use of such propellant for medical purposes. We presently have a large reserve of pharmaceutical grade propellant sufficient for our testing purposes and a contract with a major manufacture. Regardless, we are taking steps to secure new propellants to use in testing, which are being phased out under the AIM Act, ormay not be available on commercially reasonable terms, if at all. Additionally, if there is a rapid destabilization of global economic conditions or a prolonged recession resulting from the pandemic, it would likely materially affect our business and the value of our common stock and warrants.securities.

The long-term health impacts associated with use of hemp derivative products are unknown.

Although there is a long history of human consumption of hemp, there is little in the way of studies on the long-term effects of hemp products use on human health. As such, there are inherent risks associated with using the Company’s hemp products. Previously unknown or unforeseeable adverse reactions arising from human consumption of hemp products may occur and consumers should consume hemp products at their own risk or in accordance with the direction of a health care practitioner. Such adverse reactions could lead to litigation involving the Company, and the Company could ultimately face significant damages and liability in certain cases in connection with such litigation and/or may have to expend significant resources defending itself against claims associated with its products and/or the health effects thereof.

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Our products may be subject to recalls for a variety of reasons.

Manufacturers and distributors of products, such as those of the Company, are sometimes subject to recall or return orders for a variety of reasons, including product defects, such as contamination, unintended harmful side effects or interactions with other substances, packaging safety and inadequate or inaccurate labeling disclosure. If any of the products produced by us are recalled due to an alleged product defect or for any other reason, we could be required to incur the unexpected expense of the recall and any legal proceedings that might arise in connection with

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the recall. We may lose a significant number of sales and may not be able to replace those sales at an acceptable margin or at all. In addition, a product recall may require significant management attention. There can be no assurance that any quality, potency or contamination problems will be detected in time to avoid unforeseen product recalls, regulatory action or lawsuits, whether frivolous or otherwise. Additionally, if any of the products produced by us were subject to recall, the reputation and goodwill of that product and/or us could be harmed. A recall for any of the foregoing reasons could lead to decreased demand for our products and could have a material adverse effect on our business, financial condition and results of operations. Additionally, product recalls may lead to increased scrutiny of our operations by regulatory agencies, requiring further management attention, increased compliance costs and potential legal fees, fines, penalties and other expenses. Furthermore, any product recall affecting the hemp industry more broadly could lead consumers to lose confidence in the safety and security of our products, which could have a material adverse effect on our business, financial condition and results of operations.

We are subject to product liability regarding our products, which could result in costly litigation and settlements.

As a distributor of hemp products, the Company faces an inherent risk of exposure to product liability claims, regulatory action and litigation if its products are alleged to have caused significant loss or injury. In addition, the sale of our products involves the risk of injury to consumers due to tampering by unauthorized third parties or product contamination. Previously unknown adverse reactions resulting from human consumption of our products alone or in combination with other medications or substances could occur. We may be subject to various product liability claims, including, among others, that our products caused injury or illness, include inadequate instructions for use or include inadequate warnings concerning possible side effects or interactions with other substances. A product liability claim or regulatory action against the Company could result in increased costs, could adversely affect our reputation with our clients and consumers generally, and could have a material adverse effect on our results of operations and financial condition of the Company.

The hemp industry faces strong opposition.

The Company believes it is possible y that large, well-funded businesses may have a strong economic opposition to the hemp industry. The hemp industry could face a material threat from the pharmaceutical industry, should hemp cannabinoids displace other drugs or encroach upon the pharmaceutical industry’s products. The pharmaceutical industry is well funded with a strong and experienced lobby that has greater funding than the hemp industry. Any inroads the pharmaceutical industry could make in halting or impeding the hemp industry would harm our business, prospects, results of operation and financial condition.

The results of future clinical research may negatively impact our business.

Research in the U.S. and internationally regarding the medical benefits, viability, safety, efficacy, dosing and social acceptance of hemp isolated cannabinoids (such as CBD or CBG) remains in the early stages. There have been relatively few clinical trials on the benefits of hemp extracts or isolated cannabinoids (such as CBD and CBG). Future research studies and clinical trials may reach negative conclusions regarding the medical benefits, viability, safety, efficacy, dosing, social acceptance or other facts and perceptions related to hemp, which could have a material adverse effect on the demand for our products with the potential to lead to a material adverse effect on our business, financial condition, results of operations or prospects.

The lack of reliable data on the hemp industry may negatively impact our results of operations.

As a result of recent and ongoing regulatory and policy changes in the hemp industry, the market data available is limited and unreliable. UntilPrior to the passage of the 2018 Farm bill, hemp manufacturing was illegal at the Federal level which prevented market research. Therefore, market research and projections by the Company of estimated total retail sales, demographics, demand, and similar consumer research, are based on assumptions from

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limited and unreliable market data, and generally represent the personal opinions of our management team as of the date of this prospectus.

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Hemp companies are subject to recent SEC investor fraud alerts and have been under greater scrutiny by the SEC than companies in other industries.

The SEC has issued an investor alert cautioning investors that scam artists often exploit “hot” industries to trick investors, including by making false promises of high returns with low risks, and that the SEC regularly receives complaints about marijuana-related investments. Consequently, such companies and offerings are often subject to heightened regulatory scrutiny. In the United States, regulators in various states have requested additional information on hemp company financings and in some cases have issued subpoenas for additional information. Due to these concerns, the Company may face more scrutiny than it would if the Company was in another industry, and may become subject to proceedings, fines, and penalties in the future.

We may be unable to obtain our cleanroom ISO levels, which may lead to contamination of our products.

Our planned filling facility, or MDI laboratory and isolate production lab is expected to be certified to cleanroom classifications ISO 613485 standards for manufacturing of medical devices. This standard is one that FDA approved products are commonly manufactured in and 7, which are a measure of how clean a cleanroom is (ISO levels are from 1 to 9, with 1 being the ‘cleanest’). These control rooms allowallows us to formulate and manufacture our products in a sterile environment. In the event we fail to maintain certain cleanroom or GMP standards, we may be unable to prevent contaminants from being introduced into our mixing or filling processes. Such contaminants may cause our products to be adulterated, which would be a violation of food and drug safety requirements for purity, and which in turn could cause an adverse reaction in end users of our products, which could result in claims for damages and product safety, fines, damages, losses, and a negative effect on our brand name, any one of which could cause the value of our securities to decrease.

We are dependent upon our current management, who may have conflicts of interest.

We are dependent upon the efforts of our current management. The majority of our officers and directors have duties and affiliations with other companies. Such involvement of our officers and directors in other businesses may therefore present a conflict of interest regarding decisions they make for the Company or with respect to the amount of time available for the Company. The loss of any of our officers or directors and, in particular, Mr. Donal R. Schmidt, Jr., our Chief Executive Officer, or Mr. D. Hughes Watler, Jr., our Chief Financial Officer, could have a materially adverse effect upon our business and future prospects. We do not have key man life insurance upon the life of any of our officers or directors.

We could be subject to hackers or ransomware attacks.

We work with sensitive pharmaceutical information including, but not limited to, trade secrets, pending patents and potentially patentable intellectual property rights. This makes us a potential target for hackers and malware or ransomware. We believe that we employee the most up to date practices we can afford to account for this type of risk. We maintain two outside consultants to regularly review and monitor our systems. With respect to online sales, we rely on large vendors to provide security as is customary in our industry. We have special corporate rules for management of our intellectual property as it is developed and transmitted to our attorneys in the patent areas including not being connect to the internet.

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RisksRelatedtoOurFinancialStatements

We have identified material weaknesses in our disclosure controls and procedures and internal control over financial reporting. If not remediated, our failure to establish and maintain effective disclosure controls and procedures and internal control over financial reporting could result in material misstatements in our financial statements and a failure to meet our reporting and financial obligations, each of which could have a material adverse effect on our financial condition and the trading price of our common stock and warrants.securities.

Maintaining effective internal control over financial reporting and effective disclosure controls and procedures are necessary for us to produce reliable financial statements. As reported in our TransitionAnnual Report on Form 10-KT10-K for the nine monthsyear ended December 31, 2020,2021, we have determined that our disclosure controls and procedures and our internal control over financial reporting were not effective at the reasonable assurance level, primarily due to a lack of segregation of duties in financial reporting, as of December 31, 2020,2021, and continue to be ineffective. Separately, management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2020,2021, and determined that such internal control over financial reporting was not effective as a result of such assessment; and further have not been effective since prior to March 31, 2020.

Management has determined that the Company had the following material weaknesses in its internal control over financial reporting as of December 31, 2021:

Entity Level Activities - The Company did not maintain an effective control environment based on the criteria established in the COSO framework. The Company has identified deficiencies in the principles associated with the control environment of the COSO framework. Specifically, these control deficiencies constitute material weaknesses, either individually or in the aggregate, relating to:

·Lack of structure and responsibility, 

·Insufficient number of qualified resources and inadequate oversight, 

·Inadequate oversight and accountability over the performance of internal control related responsibilities, 

·Ineffective assessment and identification of risks impacting internal control, and 

·Ineffective evaluation and determination as to whether the components of internal control were present and functioning. 

Control Activities - The Company did not have adequate selection and development of effective control activities, general controls over technology and effective policies and procedures. These deficiencies attributed to the following individual control activities:

·The Company did not design and maintain effective controls over certain IT general controls for information systems that are relevant to the preparation of our financial statements. Specifically, we did not design and maintain controls to ensure appropriate segregation of duties, adequately restricted user access to certain financial applications and data to appropriate Company personnel, and monitoring of IT control activities. These IT deficiencies, when aggregated, could result in misstatements potentially impacting all financial statement accounts and disclosures that would not be prevented or detected, 

·The Company did not design and maintain controls over the documentation relating to the completeness and accuracy of the accounting for inventory transactions, specifically procedures over the existence, completeness, and accuracy of data used to support accounts related to inventory and cost of sales. 

Additionally, in connection with the most recent periodDecember 31, 2020, year end audit, the Company’s independent auditors recommended that management improve their processes and identified certain material weaknesses in inventory control. The Company plans to address such material weaknesses and auditor recommendations once the Company has raised additional funding and is able to better segregate duties of personnel.

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A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company'sCompany’s annual or interim financial statements will not be prevented or detected on a timely basis. Accordingly, a material weakness increases

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the risk that the financial information we report contains material errors. A control deficiency exists when the design or operation of a control does not allow management or employees, in the normal course of performing their assigned functions, to prevent or detect misstatements on a timely basis.

Maintaining effective disclosure controls and procedures and effective internal control over financial reporting are necessary for us to produce reliable financial statements and the Company is committed to remediating its material weaknesses in such controls as promptly as possible. However, there can be no assurance as to when these material weaknesses will be remediated or that additional material weaknesses will not arise in the future. Any failure to remediate the material weaknesses, or the development of new material weaknesses in our internal control over financial reporting, could result in material misstatements in our financial statements and cause us to fail to meet our reporting and financial obligations on a timely and accurate basis. If our financial statements are not accurate, investors may not have a complete understanding of our operations or may lose confidence in our reported financial information. Likewise, if our financial statements are not filed on a timely basis as required by the SEC, OTC Markets, or any stock exchange, as applicable, we could face severe consequences from those authorities. In any of these cases, it could result in a material adverse effect on our business, on our financial condition or have a negative effect on the trading price of our common stock and warrants. Further, if we fail to remedy this deficiency (or any other future deficiencies) or maintain the adequacy of our disclosure controls and procedures and our internal controls, we could be subject to regulatory scrutiny, civil or criminal penalties or shareholder litigation against us or our management.

We can give no assurance that the measures we have taken and plan to take in the future will remediate the material weakness identified or that any additional material weaknesses or restatements of our financial statements will not arise in the future due to a failure to implement and maintain adequate internal control over financial reporting or circumvention of those controls.

Further, in the future, if we cannot conclude that we have effective internal control over our financial reporting, or if our independent registered public accounting firm is unable to provide an unqualified opinion regarding the effectiveness of our internal control over financial reporting, investors could lose confidence in the reliability of our financial statements, which could lead to a decline in our stock price. Failure to comply with reporting requirements could also subject us to sanctions and/or investigations by the SEC, OTC Markets, or any stock exchange or NASDAQ, as applicable, or other regulatory authorities.

In addition, even if we are successful in strengthening our controls and procedures, those controls and procedures may not be adequate to prevent or identify irregularities or facilitate the fair presentation of our financial statements or our periodic reports filed with the SEC.

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Regulatory, LicensingandIntellectualProperty and Related Risks

We operate in highly regulated industries where the regulatory environments are rapidly developing and we may not always succeed in complying fully with applicable regulatory requirements in all jurisdictions where we carry on business.

Our business and activities are heavily regulated and are subject to various laws, regulations and guidelines by governmental authorities (including, in the United States,U.S., the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), the Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC) and analogous state agencies, including, but not limited to, the Texas Department of State Health Services), relating to, among other things, the manufacture, marketing, management, transportation, storage, sale, pricing and disposal of hemp-based products, and also including laws, regulations and guidelines relating to health and safety, insurance coverage, the conduct of operations and the protection of the environment (including relating to emissions and discharges to water, air and land, the handling and disposal of hazardous and non-hazardous materials and wastes). Our products are not approved by the FDA or under the Federal Food, Drug, and Cosmetics Act (FFDCA),FFDCA, or the State of Texas (or any other state). Our operations may also be affected in varying degrees by government regulations with respect to, but not limited to, price controls, export controls, controls on currency remittance, increased income taxes, restrictions on foreign investment and government policies rewarding contracts to local competitors or requiring domestic producers or vendors to purchase supplies from a particular jurisdiction. Laws, regulations and guidelines, applied generally, grant government agencies and self-regulatory bodies broad administrative discretion over our activities, including the power to limit or restrict business activities as well as impose additional disclosure requirements on our products and services.

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Achievement of our business objectives is contingent, in part, upon compliance with regulatory requirements enacted by these governmental authorities and obtaining all necessary regulatory approvals for the production, storage, transportation, sale, import and export, as applicable, of our products.  The hemp industry is still a new industry. The effect of relevant governmental authorities’ administration, application and enforcement of their respective regulatory regimes and delays in obtaining, or failure to obtain, applicable regulatory approvals which may be required may significantly delay or impact the development of markets, products and sales initiatives and could have a material adverse effect on our business, financial condition and results of operations.  For example, in the United States,U.S., registered federal trademark protection is only available for goods and services that can be lawfully used in interstate commerce; and the U.S. Patent and Trademark Office (USPTO) is not currently approving any trademark applications for hemp, or certain goods containing U.S. hemp-derived CBD.

The regulatory environment for our products is rapidly developing, and the need to build and maintain robust systems to comply with different and changing regulations in multiple jurisdictions increases the possibility that we may violate one or more applicable requirements. While we endeavor to comply with all relevant laws, regulations and guidelines, any failure to comply with the regulatory requirements applicable to our operations could subject us to negative consequences, including, civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, asset seizures, revocation or imposition of additional conditions on licenses to operate our business, the denial of regulatory applications (including, in the U.S., by other regulatory regimes that rely on the positions of the DEA, FDA and USDA in the application of their respective regimes), the suspension or expulsion from a particular market or jurisdiction or of our key personnel, or the imposition of additional or more stringent inspection, testing and reporting requirements, any of which could materially adversely affect our business and financial results. In the United States, failure to comply with FDA and USDA requirements (and analogous state agencies, including the requirements of the Texas Department of State Health Services) may result in, among other things, injunctions, product withdrawals, recalls, product seizures, fines and criminal prosecutions. The outcome of any regulatory or agency proceedings, investigations, audits, and other contingencies could harm our reputation, require us to take, or refrain from taking, actions that could harm our operations or require us to pay substantial amounts of money, harming our financial condition. Increasingly, communication and coordination among regulators has led in other industries to coordinated responses to regulatory and licensure applications. To the extent that regulators coordinate responses to license applications and regulatory conditions, limitations or denials of licenses in one jurisdiction may lead to denials in other jurisdictions. There can be no assurance that any pending or future regulatory or agency proceedings, investigations and audits will not result in substantial costs or a diversion of management’s attention and resources, negatively impact our future growth plans and opportunities or have a material adverse impact on our business and financial condition.

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The State of Texas legalized the manufacturing, consumption and export of legal hemp products containing CBD under Texas House Bill 1325 signed by Governor Abbott on June 10, 2019 and we were recentlysubsequently granted a Consumable Hemp Product license. While the Company believes that it meets all known requirements of a license for manufacture of legal hemp products, there is no guarantee that the State of Texas will renew the license and/or will not revoke such license, and if either of those events occur, the Company may be forced to move its operations to another state or curtail its operations altogether. The cost of moving its operations and/or penalties or fines in connection with its failure to obtain a license, may have a material adverse effect on the Company’s results of operations and the value of its securities.

We are constrained by law in our ability to market and advertise our products.

Our marketing and advertising are subject to regulation by various regulatory bodies in the jurisdictions we operate. In the United States, our advertising is subject to regulation by the FTC under the Federal Trade Commission Act as well as the FDA under the FFDCA and USDA, including as amended by the Dietary Supplement Health and Education Act of 1994, and by state agencies under analogous and similar state and local laws.  Some U.S. states in the United States also permit content, advertising and labeling laws to be enforced by state attorney generals, who may seek civil and criminal penalties, relief for consumers, Class Action certifications, class wide damages and recalls of products sold by us. There has also been a recent increase in private litigation that seeks, among other things, relief for consumers, Class Action certifications, class wide damages and recalls of products.  We could become a target of such private Class Action litigation.  Any actions against us by governmental authorities or private litigants could have a material and adverse effect on our business, financial condition, operating results, liquidity, cash flow and operational performance.

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The license we have to use and commercialize the ‘Desirick Procedure’ is only exclusive in four states, and even in those states, is subject to licenses which were existing as of February 9, 2021.

On February 9, 2021, EM3 Methodologies, LLC (“EM3”) provided us with a royalty-free, perpetual license (unless terminated by the Company) to use the Desirick Procedure or any derivation thereof and its application and use, including, but not limited to, related consumables (cans, valves, and actuators), filling equipment for pMDIs, and/or plastic testing vials and training, support or maintenance thereon of any combination thereof, and all intellectual property of EM3 relating to the foregoing, on an exclusive basis in the states of Texas, California, Florida and Nevada (subject to pre-existing licensing rights which have been provided by EM3 in such jurisdictions; provided that we currently have no knowledge of any such pre-existing licensing rights), and on a non-exclusive basis throughout the rest of the world, in consideration for $10. As such, while our license is exclusive in the four states described above, such license is subject to pre-existing license rights which existed as of February 9, 2021, and is non-exclusive in every other state and throughout the world. Consequently, competitors could compete against us in other states, and throughout the rest of the world using the licensed intellectual property, or may already have license rights to the intellectual property in those four states, which remain valid under the terms of the February 9, 2021 license. As a result, we may face competition for our products and future products using the licensed intellectual property and may have no remedy to prevent such competition pursuant to the terms of the license.

Each State and other jurisdiction has its own licensing requirements and regulations when it comes to the sale of cannabinoid products.

We plan in the future to offer products in states other than Texas, California, Florida and Nevada in the future and in foreign jurisdictions. Each state and foreign jurisdiction has its own licensing requirements and regulations. As such, we will need to comply with various rules and requirements which may not be consistent from one jurisdiction to another. The failure to comply with applicable rules and requirements could result in us being prohibited from offering our products in a jurisdiction, fines, penalties or other liabilities. Furthermore, significant resources will be needed to stay on top of changing regulations and requirements to ensure compliance with changes in laws. In the event we fail to comply with applicable laws it could have a material adverse effect on our results of operations and the value of our securities.

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The FDA has not approved any of the Company’s products.

While the Company’s MDIs are made using FDA listed cans, valves, actuators, propellant and excipients, the Company’s products have not been approved by the FDA.FDA-provided that no approval for such products has been sought. To date the Company is only aware of one hemp or CBD product which is FDA approved.approved, that being Epediolex, an oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. The Company and (to the Company’s knowledge) the entire CBD marketplace sells products under the “no enforcement position” of the FDA, which has not been codified (as discussed in greater detail below, , under “Description of Business-RegulationBusiness-Regulation”). The lack of FDA approval may prevent market acceptance of our products, result in liability from consumers, or potentialpotentially result in liability from the FDA in the future, any one of which could have a material adverse effect on our results of operations.

The propellants we use in our products contain greenhouse gases and may be subject to future restrictions or limitations on use.

The propellants we use in our products contain greenhouse gases. The U.S. government, under President Biden, has initiated a renewed push to reduce the use of greenhouse gases, which have been found to have an impact on global climate. In the event the specific propellants we use in our products are restricted, limited, or phased out, or it becomes more expensive for us to obtain such propellants in the future, our expenses may increase and we may be forced to reformulate our products to use different propellants, which may be costly and/or time consuming, or may produce inferior products. Any of the above may cause the value of our securities to decline and may have an adverse effect on our revenues and results of operations.

Because we plan to manufacture and sell CBD products, it is possible that, in the future, we may have difficulty accessing the service of banks.

While industrial hemp cultivation was legalized by the 2018 Farm Bill, the FDA is choosing to regulate certain hemp products, including CBD. It is possible that the circumstances surrounding the FDA’s handling of CBD-related issues could cause us to have difficulty securing services from banks, in the future.

The FDA limits our ability to discuss the potential medical benefits of CBD.

Under FDA rules, it is illegal for companies to make “health claims” or claim that a product has a specific medical benefit, without first getting FDA approval for such claim. The FDA has not recognized any medical benefits derived from CBD, which means that the Company is not legally permitted to advertise any potential health claims related to its CBD products. Because of the perception among many consumers that CBD is a health/medicinal product, whether or not such perceptions are true, the Company’s inability to make such health claims about its CBD products, may limit the Company’s ability to market and sell its product to consumers, which could negatively impact the Company’s revenues and profits.

If we are unable to protect our intellectual property, our business may be adversely affected.

We must protect the proprietary nature of the intellectual property used in our business. There can be no assurance that trade secrets and other intellectual property will not be challenged, invalidated, misappropriated or circumvented by third parties. Currently, our intellectual property includes certain non-provisional and provisional patent applications, trademarks and know-how related to business, product and technology development. We plan on taking the necessary steps, including but not limited to the filing of additional patents as appropriate. There is no assurance any additional patents will issue or that when they do issue they will include all of the claims currently included in the applications. Even if they do issue, those new patents and our existing patents must be protected against possible infringement. Nonetheless, we currently rely on contractual obligations of our employees and contractors to maintain the confidentiality of our products. To compete effectively, we need to develop and continue to maintain a proprietary position with respect to our technologies, and business.

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The risks and uncertainties that we face with respect to intellectual property rights principally include the following:

·currently, we only have non-provisional and provisional patent applications in place, which may not result in full patents being granted, and any full patent applications that we file may not result in issued patents or may take longer than expected to result in issued patents; 

·we may be subject to interference proceedings; 

·other companies may claim that patents applied for by, assigned or licensed to, us infringe upon their own intellectual property rights; 

·we may be subject to trademark opposition proceedings in the U.S. and in foreign countries; 

·any patents that are issued to us may not provide meaningful protection; 

·we may not be able to develop additional proprietary technologies that are patentable; 

·other companies may challenge patents licensed or issued to us as invalid, unenforceable or not infringed; 

·other companies may independently develop similar or alternative technologies, or duplicate our technologies; 

·other companies may design around technologies that we have licensed or developed; 

·any patents issued to us may expire and competitors may utilize the technology found in such patents to commercialize their own products; and 

·enforcement of patents is complex, uncertain and expensive. 

It is also possible that others may obtain issued patents that could prevent us from commercializing certain aspects of our products or require us to obtain licenses requiring the payment of significant fees or royalties in order to enable us to conduct our business. If we license patents, our rights will depend on maintaining our obligations to the licensor under the applicable license agreement, and we may be unable to do so. Furthermore, there can be no assurance that the work-for-hire, intellectual property assignment and confidentiality agreements entered into by our employees and consultants, advisors and collaborators will provide meaningful protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure of such trade secrets, know-how or other proprietary information. The scope and enforceability of patent claims are not systematically predictable with absolute accuracy. The strength of our own patent rights depends, in part, upon the breadth and scope of protection provided by the patent and the validity of our patents, if any.

We operate in an industry with the risk of intellectual property litigation. Claims of infringement against us may hurt our business.

Our success depends, in part, upon non-infringement of intellectual property rights owned by others and being able to resolve claims of intellectual property infringement without major financial expenditures or adverse consequences. Participants that own, or claim to own, intellectual property may aggressively assert their rights. From time to time, we may be subject to legal proceedings and claims relating to the intellectual property rights of others. Future litigation may be necessary to defend us or our clients by determining the scope, enforceability, and validity of third-party proprietary rights or to establish its proprietary rights. Some competitors have substantially greater resources and are able to sustain the costs of complex intellectual property litigation to a greater degree and for longer periods of time. In addition, patent holding companies that focus solely on extracting royalties and settlements by enforcing patent rights may target us. Regardless of whether claims that we are infringing patents or other intellectual property rights have any merit, these claims are time-consuming and costly to evaluate and defend and could:

·cause delays or stoppages in providing products; 

·divert management’s attention and resources; 

·require technology changes to our products that would cause our Company to incur substantial cost; 

·subject us to significant liabilities; and 

·require us to cease some or all of its activities. 

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In addition to liability for monetary damages, which may be tripled and may include attorneys’ fees, or, in some circumstances, damages against clients, we may be prohibited from developing, commercializing, or continuing to provide some or all of our products unless we obtain licenses from, and pay royalties to, the holders of the patents or other intellectual property rights, which may not be available on commercially favorable terms, or at all.

We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.

We have limited intellectual property rights outside the United States. Filing, prosecuting and defending patents on products in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property to the same extent as laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patents to develop their own products and further, may export otherwise infringing products to territories where we have patents, but enforcement is not as strong as that in the United States.

Many companies have encountered significant problems in protecting and defending intellectual property in foreign jurisdictions. The legal systems of certain countries, particularly China and certain other developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. To date, we have not sought to enforce any intellectual property rights in these foreign jurisdictions. Proceedings to enforce our intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our intellectual property at risk of being invalidated or interpreted narrowly and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. The requirements for patentability may differ in certain countries, particularly developing countries. Certain countries in Europe and developing countries, including China and India, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we and our licensors may have limited remedies if patents are infringed or if we or our licensors are compelled to grant a license to a third party, which could materially diminish the value of those patents. This could limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

If we are unable to obtain or defend our pending patents, our business could be materially adversely affected.

Our patent position is highly uncertain and involves complex legal and factual questions. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced under our pending patents or in third-party patents. For example, we might not have been the first to make the inventions covered by each of our non-provisional and provisional patent applications; we might not have been the first to file patent applications for these inventions; others may independently develop similar or alternative technologies or duplicate any of our technologies; it is possible that none of our non-provisional and provisional patent applications will result in issued patents; our issued patents may not provide a basis for commercially viable technologies, or may not provide us with any competitive advantages, or may be challenged and invalidated by third parties; and, we may not develop additional proprietary technologies that are patentable.

As a result, our future patents (if any) may not be valid and we may not be able to obtain and enforce patents and to maintain trade secret protection for the full commercial extent of our technology. The extent to which we are unable to do so could materially harm our business.

We have applied for and plan to continue to apply for patents for certain products. Such applications may not result in the issuance of any patents, and any patents now held or that may be issued may not provide us with adequate protection from competition. Furthermore, it is possible that patents issued or licensed to us may be challenged successfully. In that event, if we have a preferred competitive position because of such patents, such

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preferred position would be lost. If we are unable to secure or to continue to maintain a preferred position, we could become subject to competition from the sale of generic products. Failure to receive, inability to protect, or expiration of our patents would adversely affect our business and operations.

Patents issued or licensed to us may be infringed by the products or processes of others. The cost of enforcing our patent rights against infringers, if such enforcement is required, could be significant, and we do not currently have the financial resources to fund such litigation. Further, such litigation can go on for years and the time demands could interfere with our normal operations. We may become a party to patent litigation and other proceedings. The cost to us of any patent litigation, even if resolved in our favor, could be substantial. Many of our competitors may be able to sustain the costs of such litigation more effectively than we can because of their substantially greater financial resources. Litigation may also absorb significant management time.

Unpatented trade secrets, improvements, confidential know-how and continuing technological innovation are important to our success. Although we attempt to and will continue to attempt to protect our proprietary information through reliance on trade secret laws and the use of confidentiality agreements with our partners, collaborators, employees and consultants, as well as through other appropriate means, these measures may not effectively prevent disclosure of our proprietary information, and, in any event, others may develop independently, or obtain access to, the same or similar information.

Risks Related to Our Common Stock, Warrants; Securities and the Offering

There is no guarantee that our application to list our common stock and warrants on the Nasdaq Capital Market will be approved, and if our common stock and warrants is listed on the Nasdaq Capital Market, there can be no assurance that we will be able to comply with the Nasdaq Capital Market’s continued listing standards.

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As a condition to consummating this offering, our common stock and warrants offered in this Prospectus must be listed on the Nasdaq Capital Market. Accordingly, we plan to applyhave applied to list our common stock and warrants on the Nasdaq Capital Market under the symbols “RTSL” and “RTSL WS”, respectively. There can be no assurance that the Nasdaq Capital Market will approve our application for the listing of our common stock and warrants. The approval process for the listing of our shares and the warrants on the Nasdaq Capital Market, or any other exchange, involves factors beyond our control.

Assuming that our common stock and warrants are listed, and assuming the consummation of this offering, there can still be no assurance that any broker will be interested in trading our securities. Therefore, it may be difficult to sell your shares of common stock or warrants if you desire or need to sell them. Our underwriters are not obligated to make a market in our securities, and even if they do make a market, they can discontinue market making at any time without notice. Neither we nor the underwriters can provide any assurance that an active and liquid trading market in our securities will develop or, if developed, that such market will continue.

If our common stock and warrants are approved for listing on the Nasdaq Capital Market, there is no guarantee that we will be able to maintain such listing for any period of time by perpetually satisfying the Nasdaq Capital Market’s continued listing requirements. Our failure to continue to meet these requirements may result in our securities being delisted from the Nasdaq Capital Market.

The absence of such a listing may adversely affect the acceptance of our common stock and warrants as currency or the value accorded by other parties. Further, if we are delisted, we would incur additional costs under state blue sky laws in connection with any sales of our securities. These requirements could severely limit the market liquidity of our common stock and warrants and the ability of our stockholders to sell our common stock and warrants in the secondary market. If our common stock and/or warrants are delisted by the Nasdaq Capital Market, our common stock and/or warrants may be eligible to trade on an over-the-counter quotation system, such as the OTCQB Market or the OTC Pink Market, where an investor may find it more difficult to sell our securities or obtain accurate quotations as to the market value of our securities. In the event our common stock and/or warrants are delisted from the Nasdaq Capital Market in the future, we may not be able to list our common stock or warrants on another national securities exchange or obtain quotation on an over-the counter quotation system.

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The warrants offered in the offering are speculative in nature.

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

Our common stock has in the past been a “penny stock” under SEC rules, and may be subject to the “penny stock” rules in the future. It may be more difficult to resell securities classified as “penny stock.”

In the past (including immediately prior to the closing of this offering), our common stock was a “penny stock” under applicable SEC rules (generally defined as non-exchange traded stock with a per-share price below $5.00). While our common stock will not be considered “penny stock” following this offering since it will be listed on the Nasdaq Capital Market, if we are unable to maintain that listing and our common stock on the Nasdaq Capital Market, unless we maintain a per-share price above $5.00, our common stock will become “penny stock.” These rules impose additional sales practice requirements on broker-dealers that recommend the purchase or sale of penny stocks to persons other than those who qualify as “established customers” or “accredited investors.” For example, broker-dealers must determine the appropriateness for non-qualifying persons of investments in penny stocks. Broker-dealers must also provide, prior to a transaction in a penny stock not otherwise exempt from the rules, a standardized risk disclosure document that provides information about penny stocks and the risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock, disclose the compensation of the broker-dealer and its salesperson in the transaction, furnish monthly account

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statements showing the market value of each penny stock held in the customer’s account, provide 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.

Legal remedies available to an investor in “penny stocks” may include the following:

·If a “penny stock” is sold to the investor in violation of the requirements listed above, or other Federal or states securities laws, the investor may be able to cancel the purchase and receive a refund of the investment. 

·If a “penny stock” is sold to the investor in a fraudulent manner, the investor may be able to sue the persons and firms that committed the fraud for damages. 

These requirements may have the effect of reducing the level of trading activity, if any, in the secondary market for a security that becomes subject to the penny stock rules. The additional burdens imposed upon broker-dealers by such requirements may discourage broker-dealers from effecting transactions in our securities, which could severely limit the market price and liquidity of our securities. These requirements may restrict the ability of broker-dealers to sell our common stock and warrants and may affect your ability to resell our common stock and warrants.

Many brokerage firms will discourage or refrain from recommending investments in penny stocks. Most institutional investors will not invest in penny stocks. In addition, many individual investors will not invest in penny stocks due to, among other reasons, the increased financial risk generally associated with these investments.

For these reasons, penny stocks may have a limited market and, consequently, limited liquidity. We can give no assurance at what time, if ever, our common stock will not be classified as a “penny stock” in the future.

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Our management team will have immediate and broad discretion over the use of the net proceeds from this offering and we may use the net proceeds in ways with which you disagree.

The net proceeds from this offering will be immediately available to our management to use at their discretion. We currently intend to use the net proceeds from this offering for research and development and sales and marketing expenses, in order to engage additional personnel, to fund working capital and general corporate purposes and possibly acquisitions of other companies, products or technologies. See “Use of Proceeds.” We have not allocated specific amounts of the net proceeds from this offering for any of the foregoing purposes. Accordingly, our management will have significant discretion and flexibility in applying the net proceeds of this offering. You will be relying on the judgment of our management with regard to the use of these net proceeds, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used appropriately. It is possible that the net proceeds will be invested in a way that does not yield a favorable, or any, return for us or our stockholders. The failure of our management to use such funds effectively could have a material adverse effect on our business, prospects, financial condition, and results of operation.

The sale of shares by our directors and officers may adversely affect the market price for our shares.

Although our officers and directors have agreed not to sell any shares of common stock for a period of 120 days after the date of this Prospectus, sales of significant amounts of shares held by our officers and directors, or the prospect of these sales, in the future could adversely affect the market price of our common stock. Management’s stock ownership may discourage a potential acquirer from making a tender offer or otherwise attempting to obtain control of us, which in turn could reduce our stock price or prevent our stockholders from realizing a premium over our stock price.

Your ownership may be diluted if additional capital stock is issued to raise capital, to finance acquisitions or in connection with strategic transactions.

We will need to raise additional funds to expand our operations or finance acquisitions by issuing equity or convertible debt securities, which would reduce the percentage ownership of our existing stockholders. Our Board of Directors has the authority, without action or vote of the stockholders, to issue all or any part of our authorized but unissued shares of common stock. Our amended articlesArticles of incorporationIncorporation, as amended, authorize us to issue up to 750,000,000800,000,000 shares of common stock and up to 100,000,000 shares of “blank check” preferred stock (of which 16.5 million

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shares of preferred stock are designated as Series A Convertible Preferred Stock, 2 million shares of preferred stock are designated as Series B Convertible Preferred Stock (of which a total of 1 million shares of Series B Preferred Stock have been earned, but not issued, as of the date of this prospectus) and 8.5 million shares of preferred stock are designated as Series C Convertible Preferred Stock). Future issuances of common stock or of certain types of preferred stock could “dilute the voting power” you have over matters on which all stockholders vote and could be dilutive to earnings per share.

Shares issuable upon the conversion of convertible notes may substantially increase the number of shares available for sale in the public market and depress the price of our common stock and warrants and our market value.

As of the date of this Prospectus, we owed approximately $2,116,000$2,528,000 under various convertible promissory notes. The conversion prices of the convertible notes initially vary between $0.05$1.25 per share and $0.40$10.00 per share, subject to a 4.99% ownership limitation for each beneficial owner of such notes. As a result, any conversion of the convertible notes and sale of shares of common stock issuable in connection with the conversion thereof may cause the value of our common stock to decline.

In addition, the common stock issuable upon conversion of the convertible notes may represent overhang that may also adversely affect the market price of our common stock and warrants. Overhang occurs when there is a greater supply of a company’s stock in the market than there is demand for that stock. When this happens, the price of the company’s stock will decrease, and any additional shares which stockholders attempt to sell in the market will only further decrease the share price. In the event of such overhang, the note holders will have an incentive to sell their common stock as quickly as possible. If the share volume of our common stock cannot absorb the discounted shares, then the value of our common stock and warrants will likely decrease.

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In order to meet our working capital needs in advance this offering, on August 4, 2021, the Company has sold ancertain Original Issue Discount Convertible DebentureDebentures to an accredited investor in the aggregate original principal amount of $1,941,176$2,352,950 (the “Debenture Debentures”) and a warrantwarrants to purchase up to 4,852,940592,360 shares of common stock of the Company (the “Investor Warrants”). The amount owed under the Debenture,Debentures, including amounts owed upon the occurrence of an event of default, may be converted, in whole or part, by the holder, into common stock of the Company, at a conversion price of $0.40 per share (the “ Conversion Price ”), provided that the outstanding amount of the Debenture automatically converts into common stock of the Company upon the closing of a qualified offering, which will be triggered by the sale of the Units, atequal to the lower of (i) the Conversion Price; and (ii) 75% of(a) $10.00 per share, or (b) a 25% discount to the offering price of the qualified offering, which will equal [$_________]Company’s common stock in connection with this offering.a Qualified Listing (as defined below)((a) or (b), as applicable, the “Conversion Price”). The conversion of the DebentureDebentures is subject to a beneficial ownership limitation of 4.99%, preventing such conversion by the holder thereof if such exercise would result in such holder and its affiliates exceeding ownership of 4.99% of our common stock, which percentage may be increased to up to 9.99%, with at least 61 days’ prior written notice by the holder thereof.

If sequential conversions of the DebentureDebentures and sales of such converted shares take place, the price of our common stock may decline. In the future, the shares of common stock, which the DebentureDebentures is convertible into or are exercisable for, may be sold without restriction pursuant to Rule 144. As a result, the sale of these shares may adversely affect the market price, if any, of our common stock.

In addition, the common stock issuable upon conversion of the DebentureDebentures may represent overhang that may also adversely affect the market price of our common stock. Overhang occurs when there is a greater supply of a company’s stock in the market than there is demand for that stock. When this happens the price of the company’s stock will decrease, and any additional shares which shareholders attempt to sell in the market will only further decrease the share price. If the share volume of our common stock cannot absorb the shares issuable upon conversion of the Debenture,Debentures, then the value of our common stock will likely decrease.

The Debenture will automatically convert into [_____] sharesCertain of our common stock uponoutstanding convertible notes and the closing of the offering described herein.Debentures include restrictions on future activities.

As described above,So long as the amount owedCompany has any obligation under the Debenture,$400,000 promissory note sold to J. Scott Suggs, a member of our Board of Directors in January 2022, the Company is prohibited from selling, leasing or otherwise disposing of any significant portion of its assets outside the ordinary course of business without the prior written consent of the holders of such notes. Such restrictions may prevent the Company from raising funds through the sale of assets and/or result in the default of certain of the Company’s outstanding obligations, which could have a material adverse effect on the Company’s results of operations and the value of its securities

So long as any portion of the Debentures remain outstanding, the Company and its subsidiaries are prohibited from undertaking any of the following without the prior written consent of the holders of at least 67% in principal amount of the then outstanding Debentures:

·other than certain permitted indebtedness (as discussed in each Debenture), entering into, creating, incurring, assuming, guaranteeing or suffering to exist any indebtedness for borrowed money of any kind, including, amounts owedbut not limited to, a guarantee, on or with respect to any of the Company’s property or assets or any interest therein or any income or profits therefrom; 

·other than certain permitted liens (as discussed in each Debenture), entering into, creating, incurring, assuming or suffering to exist any liens of any kind, on or with respect to any of the Company’s property or assets or any interest therein or any income or profits therefrom; 

·amending its charter documents, including, without limitation, its Articles of Incorporation or Bylaws, in any manner that materially and adversely affects any rights of any holder of the Debentures; 

·repaying, repurchasing or offering to repay, repurchase or otherwise acquire more than a de minimis number of shares of the Company’s common stock or common stock equivalents other than as to (i) the shares of common stock issuable upon conversion of the occurrenceDebentures or exercise of an eventthe warrants granted with the Debentures and (ii) repurchases of default, may be converted, in whole or part, by the holder, into common stock or common stock equivalents of departing officers and directors of the Company, at a conversion price of $0.40 per share, provided that such repurchases shall not exceed an aggregate of $100,000 for all officers and directors during the outstanding amountterm of the Debenture automatically converts into common stockapplicable Debenture;  

·repaying, repurchasing or offering to repay, repurchase or otherwise acquire any indebtedness, other than the Debentures, if on a pro-rata basis, except for certain amounts advanced by management that were outstanding on the date the Debentures were entered into; 

·paying cash dividends or distributions on any equity securities of the Company upon the closing of a qualified offering, which will be triggered by the sale of the Units, at the lower of (i) the Conversion Price; and (ii) 75% of the offering price of the qualified offering, which will equal [$_________] in connection with this offering. The conversion of the Debenture is subject to a beneficialCompany; 

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ownership limitation·entering into any transaction with any affiliate of 4.99%, preventingthe Company which would be required to be disclosed in any public filing with the SEC, unless such conversiontransaction is made on an arm’s-length basis and expressly approved by a majority of the holder thereof,disinterested directors of the Company (even if such exercise wouldless than a quorum otherwise required for board approval); or 

·entering into any agreement with respect to any of the foregoing. 

Such restrictions may prevent the Company from raising funds through the sale of assets and/or the other activities set forth above and/or result in such holder and its affiliates exceeding ownershipthe default of 4.99% of our common stock, which percentage may be increased to up to 9.99%, with at least 61 days’ prior written notice by the holder thereof. As a resultcertain of the above,Company’s outstanding obligations, which could have a totalmaterial adverse effect on the Company’s results of [___________] sharesoperations and the value of common stock, subject to the beneficial ownership limitation, will be issued upon the automatic conversion of the Debenture, upon the closing of this offering. Such issuance will cause immediate and substantial dilution to the then-existing stockholders.its securities.

The issuance of common stock upon conversion of the DebentureDebentures and upon exercise of outstanding warrants will cause immediate and substantial dilution.

The issuance of common stock upon conversion of the DebentureDebentures and upon exercise of the outstanding warrants to purchase 8,204,3371,280,232 shares of common stock, at exercise prices of $0.05$1.25 to $0.40$10.00 per share (subject to certain anti-dilution rights), will result in immediate and substantial dilution to the interests of other stockholders since the holders of the DebentureDebentures and warrants may ultimately receive and sell the full number of shares issuable in connection with the conversion and exercise of such securities. Although the DebentureDebentures may not be converted and the warrants may not be exercised if such conversion/exercise would cause the holders thereof to own more than 4.99% of our outstanding common stock (which percentage may be increased to 9.99% with 61 days’ prior written notice), this restriction does not prevent the holders subject to such restrictions from converting/exercising some of their holdings, selling those shares, and then converting the rest of its holdings, while still staying below the 4.99%/9.99% limit. In this way, the holders of the DebentureDebentures and warrants could sell more than any applicable ownership limit while never actually holding more shares than the applicable limits allow. If the holders of the DebentureDebentures and warrants choose to do this, it will cause substantial dilution to the then existing holders of our common stock.

If exercises of the warrants and sales of shares issuable upon exercise thereof take place, the price of our common stock may decline. In addition, the common stock issuable upon exercise of the warrants may represent overhang that may also adversely affect the market price of our common stock. Overhang occurs when there is a greater supply of a company’s stock in the market than there is demand for that stock. When this happens the price of the company’s stock will decrease, and any additional shares which shareholders attempt to sell in the market will only further decrease the share price. If the share volume of our common stock cannot absorb shares sold by the warrant holders, then the value of our common stock will likely decrease.

We currently owe a significant amount of money under our outstanding Debenture.

As of the date of this Prospectus, we owe approximately $1,941,176$2,352,940 under the Debenture.Debentures. We do not presently have sufficient funds to repay such Debenture,Debentures, and if we are unable to raise additional funds in the future to repay such amount, or we are unable to complete this offering, which offering will trigger the automatic conversion of the DebentureDebentures into shares of common stock, such failure could have a material adverse effect on our financial condition or results of operations and cause any investment in the Company to decline in value or become worthless.

Certain warrants we have granted include anti-dilutive rights which will be triggered in connection with this offering.

Warrants to purchase 5,095,587592,060 shares of common stock, which we granted in August 2021 and May 2022, have an exercise price of $0.40$10.00 per share and have anti-dilution rights. Specifically, if we issue, or are deemed to have issued, common stock or common stock equivalents at a price less than the then effective exercise price of the warrants for a period of 24 months following the date our common stock is uplisted to the Nasdaq Capital Market, subject to certain customary exceptions and the sale of up to $1.5 million in private transactions, the exercise price of the warrants is automatically reduced to such lower value, and the number of shares of common stock issuable upon exercise thereafter is adjusted proportionately, so that the aggregate exercise price payable upon exercise of such warrants is the same prior to and after such reduction in exercise price. As a result, the effect of the anti-dilution right may cause significant dilution to existing shareholders. The warrants (except for warrants to purchase 9,706 shares, which expired in August 2026) are exercisable until August 2026.2028.

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The sale of the common stock and warrants offered pursuant to the registration statement of which this prospectus which forms a part, will result in the exercise price of the Investor Warrants decreasing from $10.00 per share to $______ per share.

Effective April 1, 2022, the Company granted a common stock purchase warrant to a Washington, DC based firm that it has engaged to provide consulting services relating to certain federal regulatory matters.  The warrant will enable the firm to purchase up to 360,000 shares of the Company’s common stock at an exercise price of $10.00 per share, or the lower of any public offering related conversion price, for a period of 10 years.  The warrant is structured to be exercisable in six separate tranches of from 160,000 shares to 40,000 shares, assuming specified performance milestones are met by the firm for each tranche. The warrant includes cashless exercise rights, a reduction in the exercise price to $7.75 per share upon a sale, merger, change of control or consolidation of the Company, automatic cashless exercise triggers, if upon expiration of the warrant the fair market value of the Company’s common stock is above the exercise price of the warrants, and anti-dilution rights, which are triggered if the Company makes an offering or sells shares of common stock or common stock equivalents below the then exercise price, in connection with the uplisting of the Company’s common stock on a securities exchange or Nasdaq, or while listed on a national securities exchange or Nasdaq, and which reduce the exercise price of the warrants automatically to such lower exercise price. The closing of the offering contemplated hereby will result in the exercise price of such warrants begin automatically reduced to $__________ per share. The holder of the warrants is subject to a trading agreement, which prevents the sale or transfer of any warrant shares until April 1, 2023, and further limiting the sale of any warrant shares to more than 5% of the average trading volume of the Company’s common stock during the period from April 2, 2023 to April 1, 2024, subject to certain other restrictions on trading, which restrictions expire 120 days after the Company’s common stock is uplisted to the Nasdaq Capital Market or NYSE.

We will owe certain pre-payment penalties under an outstanding Promissory Note upon the closing of this offering.

On January 28, 2022, we entered into a Securities Purchase Agreement (the “Suggs Purchase Agreement”), with J. Scott Suggs, a member of our Board of Directors (“Suggs”), pursuant to which the Company agreed to sell, and Suggs agreed to purchase, a Promissory Note (the “Suggs Note”). The Suggs Note was purchased for, and has an initial face amount of, $400,000. The Suggs Note accrues interest at 18% per annum, compounded monthly (at the end of each month), until the earlier of (i) January 26, 2023 (the “Maturity Date”) or (ii) ten days from the date that the Company’s common stock is listed on a national exchange and that the Company receives funding under any underwritten offering in connection therewith, which will include the offering contemplated by the registration statement of which this prospectus forms a part (the “Pre-Payment Date”), when all accrued interest and outstanding principal under the Suggs Note is required to be paid in a single lump sum. If the Pre-Payment Date occurs prior to the Maturity Date, the Company will be required to pay a prepayment penalty equal to the outstanding principal balance of the Suggs Note multiplied by 25.44% ($101,760), less the amount of total accrued interest owed under the Suggs Note as of the Pre-Payment Date (the “Pre-Payment Penalty”). No Pre-Payment Penalty will be due if the Suggs Note is repaid on the Maturity Date, provided the Pre-Payment Date has not previously occurred. Other than on the Pre-Payment Date, the Company has no right to accelerate payments or prepay the Suggs Note, except with the prior written approval of Suggs.

The sale of the common stock and warrants offered pursuant to the registration statement of which this prospectus forms a part, will trigger a Pre-Payment Penalty of approximately $42,000 in connection with the required repayment of the Suggs Note.

The concentration of our common stock ownership by our current management will limit your ability to influence corporate matters.

Our directors and executive officers beneficially own and are able to vote in the aggregate 27.0% of our outstanding common stock prior to this offering, and will own approximately _______% of our outstanding common stock after this offering (_______% assuming the full exercise of the underwriters’ over-allotment option)

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based on an assumed public offering price of $_______ per share on September ___, 2021,2022, which was the last reported sale price of our common stock on the OTC Pink Market.Market on ____, 2022, provided that our directors, executive officers and certain employees together can vote over 50% of our outstanding common stock, and will continue to be able to vote over 50% of our common stock after the offering. As such, our directors and executive officers, as stockholders, will have the ability to exert significant influence over all corporate activities, including the election or

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removal of directors and the outcome of tender offers, mergers, proxy contests or other purchases of common stock that could give our stockholders the opportunity to realize a premium over the then-prevailing market price for their shares of common stock.  This concentrated control will limit your ability to influence corporate matters and, as a result, we may take actions that our stockholders do not view as beneficial.  In addition, such concentrated control could discourage others from initiating changes of control.  In such cases, the perception of our prospects in the market may be adversely affected and the market price of our common stock and warrants may decline.

We could issue “blank check” preferred stock without stockholder approval with the effect of diluting then current stockholder interests and impairing their voting rights, and provisions in our charter documents and under Nevada corporate law could discourage a takeover that stockholders may consider favorable.

Our Amended and Restated Articles of Incorporation, as amended, authorize the issuance of up to 100,000,000 shares of “blank check” preferred stock with designations, rights and preferences as may be determined from time to time by our Board of Directors. Our Board of Directors is empowered, without stockholder approval, to issue a series of preferred stock with dividend, liquidation, conversion, voting or other rights which could dilute the interest of, or impair the voting power of our common stockholders. The issuance of a series of preferred stock could be used as a method of discouraging, delaying or preventing a change in control.

We have no intention of declaring dividends in the foreseeable future.

The decision to pay cash dividends on our common stock rests with our Board of Directors and will depend on our earnings, unencumbered cash, capital requirements and financial condition.  We do not anticipate declaring any dividends in the foreseeable future, as we intend to use any excess cash to fund our operations.  Investors in our common stock should not expect to receive dividend income on their investment, and investors will be dependent on the appreciation of our common stock to earn a return on their investment.

There may not be sufficient liquidity in the market for our securities in order for investors to sell their shares. The market price of our comment stock may be volatile.

The market price of our common stock and warrants will likely be highly volatile, as is the stock market in general. Some of the factors that may materially affect the market price of our common stock and warrants are beyond our control, such as conditions or trends in the industry in which we operate or sales of our common stock and warrants. This situation is attributable to a number of factors, including the fact that we are a small company which is relatively unknown to stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to be risk averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable.

As a consequence, there may be periods of several days or more when trading activity in our shares is minimal or non-existent, as compared to a mature issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price. It is possible that a broader or more active public trading market for our common stock and warrants will not develop or be sustained, or that trading levels will not continue. These factors may materially adversely affect the market price of our common stock and warrants, regardless of our performance. In addition, the public stock markets have experienced extreme price and trading volume volatility. This volatility has significantly affected the market prices of securities of many companies for reasons frequently unrelated to the operating performance of the specific companies. These broad market fluctuations may adversely affect the market price of our common stock and warrants.

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

You will incur immediate and substantial dilution as a result of this offering. After giving effect to the sale by us of up to $_______________ in Units offered in this offering, at an assumed public offering price of $______ per Unit, which was the last reported sale price of our common stock on the OTC Pink Market, on September ___, 2021,2022, and after deducting the underwriters’ discounts and commissions and other estimated offering expenses

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payable by us, investors in this offering can expect an immediate dilution of $_______ per share, or ______%. For a further description of the dilution that investors in this offering may experience, see “Dilution.”

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In addition, the common stock issuable upon exercise of the warrants may represent overhang that may also adversely affect the market price of our common stock. In the event of such overhang, the warrant holders will have an incentive to sell their common stock as quickly as possible (subject to applicable holding periods under Rule 144 for cash exercises). If the share volume of our common stock cannot absorb the discounted shares, then the value of our common stock will likely decrease.

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

Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock, if issued, and the shares of common stock issuable upon conversion thereof, will cause significant dilution to existing stockholders.

Pursuant to certain contractual obligations, we have agreed to issue up to 16.5 million shares of Series A Preferred Stock, 2 million shares of Series B Preferred Stock (of which a total of 1 million shares of Series B Preferred Stock have been earned, but not issued, as of the date of this prospectus) and 8.5 million shares of Series C Preferred Stock. Each of such shares of preferred stock, if earned and issued, allow the holders thereof the right to, or in the case of the Series B and Series C Preferred Stock, provided for the automatic conversion thereof into, common stock on a one-for-one1-for-25 basis, on the second anniversary of the agreement pursuant to which they are contingently issuable. In the event shares of Series B Preferred Stock and/or Series C Preferred Stock are earned and converted into common stock, such conversions of preferred stock will create significant dilution to existing stockholders.

In addition, the common stock issuable upon conversion of the Series A, B and C Preferred Stock may represent overhang that may also adversely affect the market price of our common stock. Overhang occurs when there is a greater supply of a company’s stock in the market than there is demand for that stock. When this happens the price of the company’s stock will decrease, and any additional shares which stockholders attempt to sell in the market will only further decrease the share price. In the event of such overhang, the Series A, B and C Preferred Stock will have an incentive to sell their common stock as quickly as possible. If the share volume of our common stock cannot absorb the discounted shares, then the value of our common stock will likely decrease.

There is a limited public market for our securities and you could lose all or part of your investment.

Our securities are currently quoted on the OTC Pink Market. We currently have a volatile, sporadic and illiquid market for our common stock, which is subject to wide fluctuations in response to several factors. The trading price of our common stock and warrants is likely to continue to be volatile. This volatility may prevent you from being able to sell your securities at or above the price you paid for your securities. Our stock price and warrant price could be subject to wide fluctuations in response to a variety of factors, which include:

·actual or anticipated variations in our results of operations; 

·our ability or inability to generate revenues; 

·the number of shares in our public float; 

·increased competition; and 

·conditions and trends in the market for our services and products. 

Our stock price and warrant price may be impacted by factors that are unrelated or disproportionate to our operating performance. These market fluctuations, as well as general economic, political and market conditions, such as recessions, interest rates or international currency fluctuations may adversely affect the market price of our common stock and the warrants. Stockholders and potential investors in our common stock and warrants should exercise caution before making an investment in us, and should not rely solely on the publicly quoted or traded stock prices in determining our common stock and warrant value, but should instead determine the value of our common stock and warrants based on the information contained in our public disclosures, industry information, and those business valuation methods commonly used to value private companies.

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Additionally, the market price of our common stock historically has fluctuated significantly based on, but not limited to, such factors as general stock market trends, announcements of developments related to our business,

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actual or anticipated variations in our operating results, our ability or inability to generate revenues, and conditions and trends in the industries in which our customers are engaged.

In recent years, the stock market in general has experienced extreme price fluctuations that have sometimes been unrelated to the operating performance of the affected companies. Similarly, the market price of our common stock and warrants may fluctuate significantly based upon factors unrelated or disproportionate to our operating performance. These market fluctuations, as well as general economic, political and market conditions, such as recessions, interest rates or international currency fluctuations may adversely affect the market price of our common stock and warrant.

Over the past 52 weeks our common stock has been subject to significant swings in trading prices, and has traded between a low of $1.62 to a high of $16.25. We expect the trading prices of our common stock to continue to be highly illiquid, sporadic and volatile in the future.

We will incur significant costs to ensure compliance with U.S. and Nasdaq Capital Market reporting and corporate governance requirements.

We will incur significant costs associated with our public company reporting requirements and with applicable U.S. and Nasdaq Capital Market corporate governance requirements (assuming our common stock and warrants are approved for listing on the Nasdaq Capital Market), including requirements under the Sarbanes-Oxley Act of 2002 and other rules implemented by the SEC and the Nasdaq Capital Market. We expect all of these applicable rules and regulations to significantly increase our legal and financial compliance costs and to make some activities more time consuming and costly. We also expect that these applicable rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified individuals to serve on our Board of Directors or as executive officers.

In the event our common stock and warrants are approved for listing on the Nasdaq Capital Market, we will need to meet certain continued listing requirements in order to not have our common stock and warrants delisted from such markets.

Among the conditions required for continued listing on the Nasdaq Capital Market are maintaining $2.5 million in stockholders’ equity, or a market value of listed securities of $35 million, or net income from continuing operations in the last fiscal year or two of the last three fiscal years of $500,000, having majority independent directors, having an audit committee of at least three members, and maintaining a stock price over $1.00 per share, among other requirements.

If we fail to timely comply with the applicable requirements of the Nasdaq Capital Market, , depending on where we choose to list our common stock and warrants, and assuming our common stock and warrants are approved for listing on such market, our stock may be delisted. In addition, even if we demonstrate compliance with the requirements above, we will have to continue to meet other objective and subjective listing requirements to continue to be listed on the applicable market. Delisting from the Nasdaq Capital Market could make trading our common stock and warrants more difficult for investors, potentially leading to declines in our share price and liquidity. Without a Nasdaq Capital Market listing, stockholders may have a difficult time getting a quote for the sale or purchase of our stock, the sale or purchase of our stock would likely be made more difficult and the trading volume and liquidity of our stock could decline. Delisting from the Nasdaq Capital Market could also result in negative publicity and could also make it more difficult for us to raise additional capital. The absence of such a listing may adversely affect the acceptance of our common stock as currency or the value accorded by other parties. Further, if we are delisted, we would also incur additional costs under state blue sky laws in connection with any sales of our securities. These requirements could severely limit the market liquidity of our common stock and warrants and the ability of our stockholders to sell our common stock and warrants in the secondary market. If our common stock and warrants are delisted by the Nasdaq Capital Market, , our common stock and warrants may be eligible to trade on an over-the-counter quotation system, such as the OTCQB market, where an investor may find it more difficult to sell our stock or obtain accurate quotations as to the market value of our common stock and warrants. In the event our common stock and warrants are delisted from the Nasdaq Capital Market, , we may not be able to list our common stock and warrants on another national securities exchange or obtain quotation on an over-the counter quotation system.

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Risks Related to theaPotentialFuture Reverse Stock Split

We have applied to list our common stock and the warrants on the Nasdaq Capital Market. If our application to the Nasdaq Capital Market is not approved or we otherwise determine that we will not be able to secure the listing of the common stock and warrants on the Nasdaq Capital Market, we will not complete the offering.

In an effort to meet the required minimum trading price requirement of the Nasdaq Capital Market, as discussed above, on March 31, 2022, we affected a 1-for-25 reverse stock split of our outstanding common stock. Notwithstanding such reverse stock split, our common stock has recently been trading below $4.00 per share, and we believe our common stock will need to (a) maintain a bid price of at least $4.00 per share on at least 30 of the 60 trading days prior to the uplisting of our common stock on the Nasdaq Capital Market (which requirement we believe has already been met); and/or (b) have a bid price of at least $4.00 per share prior to the uplisting of our common stock on the Nasdaq Capital Market, provided that Nasdaq approves our uplisting and we meet the other required uplisting criteria. As a result, our Board of Directors may take action in the future, without shareholder approval, pursuant to the power provided to the Board of Directors by the Nevada Revised Statutes, in the event they deem such action necessary, to affect an additional reverse stock split of both our outstanding and authorized and unissued shares of common stock, in the event the Board of Directors believes that such reverse stock split is necessary for us to meet the listing requirements of the Nasdaq Capital Market. No reverse stock split other than the 1-for-25 reverse stock split described above which was effective March 31, 2022, and has been retroactively reflected throughout this prospectus, has been approved to date. Any further reverse stock split will be reflected in an amendment to the registration statement of which this prospectus forms a part prior to the effectiveness of such registration statement.

We anticipate effectingmay effect a further reverse stock split of our outstanding common stock prior to the closing of this offering.

We expect that theany future reverse stock split will increase the market price of our common stock while our stock is trading and enable us to meet the minimum market price requirement of the listing rules of the Nasdaq Capital Market .Market. However, the effect of a reverse stock split upon the market price of our common stock cannot be predicted with certainty, and the results of reverse stock splits by companies in similar circumstances have been varied. It is possible that the market price of our common stock following the reverse stock split will not increase sufficiently for us to be in compliance with the minimum market price requirement of the Nasdaq Capital Market, , or if it does, that such price will be sustained.sustained (for example, our common stock was trading at $6.75 per share (as adjusted) immediately prior to our March 31, 2022, 1-for-25 reverse stock split, and has since fallen to below $4.00 per share). If we are unable to meet the minimum market price requirement, we may be unable to list our shares on the Nasdaq Capital Market, in which case such an offering may not be completed.

Even if the reverse stock split achieves the requisite increase in the market price of our common stock, there can be no assurance that we will be approved for listing on the Nasdaq Capital Market or able to comply with other continued listing standards of the Nasdaq Capital Market.

Even if the market price of our common stock increases sufficiently so that we comply with the minimum market price requirement, we cannot assure you that we will be able to comply with the other standards that we are required to meet in order to be approved for listing on the Nasdaq Capital Market or maintain a listing of our common stock on the Nasdaq Capital Market .Market. Our failure to meet these requirements may result in our common stock being delisted from the Nasdaq Capital Market .Market.

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

The liquidity of the shares of our common stock may be affected adversely by the reverse stock split given the reduced number of shares that will be outstanding following the reverse stock split. In addition, the reverse stock split may increase the number of stockholders who own odd lots (less than 100 shares) of our common stock, creating the potential for such stockholders to experience an increase in the cost of selling their shares and greater difficulty affecting such sales.

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GeneralRiskFactors

We will continue to incur increased costs as a result of being a reporting company, and given our limited capital resources, such additional costs may have an adverse impact on our profitability.

We are an SEC reporting company. The rules and regulations under the Exchange Act require reporting companies to provide periodic reports with interactive data files, which require that we engage legal, accounting and auditing professionals, and eXtensible Business Reporting Language (XBRL) and EDGAR (Electronic Data Gathering, Analysis, and Retrieval) service providers. The engagement of such services can be costly, and we may continue to incur additional losses, which may adversely affect our ability to continue as a going concern. In addition, the Sarbanes Oxley Act of 2002, as well as a variety of related rules implemented by the SEC, have required changes in corporate governance practices and generally increased the disclosure requirements of public companies. For example, as a result of being a reporting company, we are required to file periodic and current reports and other information with the SEC and we have adopted policies regarding disclosure controls and procedures and regularly evaluate those controls and procedures.

The additional costs we continue to incur in connection with becoming a reporting company (expected to be approximately a hundred thousand dollars per year) will continue to further stretch our limited capital resources. Due to our limited resources, we have to allocate resources away from other productive uses in order to continue to comply with our obligations as an SEC reporting company. Further, there is no guarantee that we will have sufficient resources to continue to meet our reporting and filing obligations with the SEC as they come due.

We may not be able to compete successfully against present or future competitors.

We do not have the resources to compete with larger providers of similar services at this time.  With the limited resources we have available, we may experience great difficulties in expanding our operations.  Competition

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from existing and future competitors could result in our inability to secure funding to expand our business.  This competition from other entities with greater resources and experience may result in our failure to maintain or expand our business, as we may never be able to successfully execute our business plan.

Our ability to grow and compete in the future will be adversely affected if adequate capital is not available.

The ability of our business to grow and compete depends on the availability of adequate capital, which in turn depends in large part on our cash flow from operations and the availability of equity and debt financing.  Our cash flow from operations may not be sufficient or we may not be able to obtain equity or debt financing on acceptable terms or at all to implement our growth strategy.  As a result, adequate capital may not be available to finance our current growth plans, take advantage of business opportunities or respond to competitive pressures, any of which could harm our business.

We may be subject to claims that we violated intellectual property rights of others, which are extremely costly to defend and could require us to pay significant damages and limit our ability to operate.

There may be intellectual property rights held by others, including issued or pending patents and trademarks, that cover significant aspects of our technologies, products, branding or business methods. Any intellectual property claims against us, regardless of merit, could be time-consuming and expensive to settle or litigate and could divert our management’s attention and other resources. These claims also could subject us to significant liability for damages and could result in our having to stop using technology, products, branding or business methods found to be in violation of another party’s rights. We might be required or may opt to seek a license for rights to intellectual property held by others, which may not be available on commercially reasonable terms, or at all. If we cannot license or develop technology, products, branding or business methods for any allegedly infringing aspect of our business, we may be unable to compete effectively. Even if a license is available, we could be required to pay significant royalties, which could increase our operating expenses. We may also be required to develop alternative non-infringing technology, content, branding or business methods, which could require significant effort and expense and be inferior. Any of these results could harm our operating results.

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If we do not successfully implement any acquisition strategies, our operating results and prospects could be harmed.

We face competition within our industry for acquisitions of businesses, technologies and assets, and, in the future, such competition may become more intense. As such, even if we are able to identify an acquisition that we would like to consummate, we may not be able to complete the acquisition on commercially reasonable terms or at all because of such competition. Furthermore, if we enter into negotiations that are not ultimately consummated, those negotiations could result in diversion of management time and significant out-of-pocket costs. Even if we are able to complete such acquisitions, we may additionally expend significant amounts of cash or incur substantial debt to finance them, which indebtedness could result in restrictions on our business and use of available cash. In addition, we may finance or otherwise complete acquisitions by issuing equity or convertible debt securities, which could result in dilution of our existing stockholders. If we fail to evaluate and execute acquisitions successfully, we may not be able to realize their benefits. If we are unable to successfully address any of these risks, our business, financial condition or operating results could be harmed.

Failure to adequately manage our planned aggressive growth strategy may harm our business or increase our risk of failure.

For the foreseeable future, we intend to pursue an aggressive growth strategy for the expansion of our operations through increased product development and marketing. Our ability to rapidly expand our operations will depend upon many factors, including our ability to work in a regulated environment, establish and maintain strategic relationships with suppliers, and obtain adequate capital resources on acceptable terms. Any restrictions on our ability to expand may have a materially adverse effect on our business, results of operations, and financial condition. Accordingly, we may be unable to achieve our targets for sales growth, and our operations may not be successful or achieve anticipated operating results.

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Additionally, our growth may place a significant strain on our managerial, administrative, operational, and financial resources and our infrastructure. Our future success will depend, in part, upon the ability of our senior management to manage growth effectively. This will require us to, among other things:

·implement additional management information systems; 

·further develop our operating, administrative, legal, financial, and accounting systems and controls; 

·hire additional personnel; 

·develop additional levels of management within our company; 

·locate additional office space; and 

·maintain close coordination among our operations, legal, finance, sales and marketing, and client service and support personnel. 

As a result, we may lack the resources to deploy our services on a timely and cost-effective basis.  Failure to accomplish any of these requirements could impair our ability to deliver services in a timely fashion or attract and retain new customers.

If we make any acquisitions, they may disrupt or have a negative impact on our business.

If we make acquisitions in the future, funding permitting, which may not be available on favorable terms, if at all, we could have difficulty integrating the acquired company’s assets, personnel and operations with our own. We do not anticipate that any acquisitions or mergers we may enter into in the future would result in a change of control of the Company. In addition, the key personnel of the acquired business may not be willing to work for us. We cannot predict the effect expansion may have on our core business. Regardless of whether we are successful in making an acquisition, the negotiations could disrupt our ongoing business, distract our management and employees and increase our expenses. In addition to the risks described above, acquisitions are accompanied by a number of inherent risks, including, without limitation, the following:

·the difficulty of integrating acquired products, services or operations; 

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·the potential disruption of the ongoing businesses and distraction of our management and the management of acquired companies; 

·difficulties in maintaining uniform standards, controls, procedures and policies; 

·the potential impairment of relationships with employees and customers as a result of any integration of new management personnel; 

·the potential inability or failure to achieve additional sales and enhance our customer base through cross-marketing of the products to new and existing customers; 

·the effect of any government regulations which relate to the business acquired; 

·potential unknown liabilities associated with acquired businesses or product lines, or the need to spend significant amounts to retool, reposition or modify the marketing and sales of acquired products or operations, or the defense of any litigation, whether or not successful, resulting from actions of the acquired company prior to our acquisition; and 

·potential expenses under the labor, environmental and other laws of various jurisdictions. 

Our business could be severely impaired if and to the extent that we are unable to succeed in addressing any of these risks or other problems encountered in connection with an acquisition, many of which cannot be presently identified. These risks and problems could disrupt our ongoing business, distract our management and employees, increase our expenses and adversely affect our results of operations.

Our business, including our costs and supply chain, is subject to risks associated with raw material costs, inflation and energy.

Our future planned operating results will be negatively impacted by increases in the prices of our materials, and we have no guarantees that prices will not rise in the future. In addition, as we expand into new categories and product types, we expect that we may not have strong purchasing power in these new areas, which could lead to higher prices than competitors for such materials. We may not be able to pass increased prices on to customers, which could adversely affect our operating results. Moreover, in the event of a significant disruption in the supply of the raw materials used in the manufacture of our future products we may not be able to locate alternative suppliers of materials of comparable quality at an acceptable price. For example, natural disasters may increase raw material costs, impacting pricing. Any delays, interruption, damage to or increased costs in the manufacture of the future products we may offer could adversely affect our operating results. We are also subject to risks associated with inflation and increasing costs of raw materials, manufacturing and energy.

Our Amended and Restated Articles of Incorporation, as amended, provides for the indemnification of officers and directors at our expense and limits their liability, which may result in a major cost to us and hurt the interests of our stockholders because corporate resources may be expended for the benefit of officers or directors.

Our Amended and Restated Articles of Incorporation, as amended, require us to indemnify to the fullest extent under Nevada law, any person who 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 or in the right of the Company) by reason of the fact that he is or was a director or officer of the Company, or, while a director or officer of the Company, is or was serving at the request of the Company as a director, officer, employee or agent of another corporation, partnership, joint venture, trust, association or other enterprise, against expenses

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(including (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with which action, suit or proceeding, if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the Company and, with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful. The termination of any action, suit or proceeding by judgment, order, settlement, conviction or upon plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that the person did not act in good faith and in a manner which he reasonably believed to be in or not opposed to the best interests of the Company and, with respect to any criminal action or proceeding, that he had reasonable cause to believe that his conduct was unlawful. Our Amended and Restated Articles of Incorporation, as amended, also provides that no director shall be personally liable to the Company, any of its stockholders or its creditors for money damages for breach of fiduciary duty as a director, except to the extent such exemption from liability or limitation thereof is not permitted under the Nevada Revised Statutes.

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We have been advised that, in the opinion of the SEC, indemnification for liabilities arising under federal securities laws is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification for liabilities arising under federal securities laws, other than the payment by us of expenses incurred or paid by a director, officer or controlling person in the successful defense of any action, suit or proceeding, is asserted by a director, officer or controlling person in connection with our activities, we will (unless in the opinion of our counsel, the matter has been settled by controlling precedent) submit to a court of appropriate jurisdiction, the question whether indemnification by us is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue. The legal process relating to this matter if it were to occur is likely to be very costly and may result in us receiving negative publicity, either of which factors is likely to materially reduce the market and price for our shares, if such a market ever develops.

Stockholders may be diluted significantly through our efforts to obtain financing and satisfy obligations through the issuance of additional shares of our common stock.

Wherever possible, our Board of Directors will attempt to use non-cash consideration to satisfy obligations. In many instances, we believe that the non-cash consideration will consist of restricted shares of our common stock or where shares are to be issued to our officers, directors and applicable consultants. Our Board of Directors has authority, without action or vote of the stockholders, to issue all or part of the authorized but unissued shares of common stock. In addition, we may attempt to raise capital by selling shares of our common stock, possibly at a discount to market. These actions will result in dilution of the ownership interests of existing stockholders, which may further dilute common stock book value, and that dilution may be material. Such issuances may also serve to enhance existing management’s ability to maintain control of the Company because the shares may be issued to parties or entities committed to supporting existing management.

Our common stock may continue to be followed by only a limited number of analysts and there may continue to be a limited number of institutions acting as market makers for our common stock and warrants.

For the foreseeable future, our common stock and warrants is unlikely to be followed by a significant number of market analysts, and there may be few institutions acting as market makers for our common stock and warrants. Either of these factors could adversely affect the liquidity and trading price of our common stock and warrants. Until our common stock and warrants are fully distributed and an orderly market develops in our common stock and warrants, if ever, the price at which it trades is likely to fluctuate significantly. Prices for our common stock and warrants are determined in the marketplace and may be influenced by many factors, including the depth and liquidity of the market for shares of our common stock and warrants, developments affecting our business, including the impact of the factors referred to elsewhere in these Risk Factors, investor perception of us and general economic and market conditions. No assurances can be given that an orderly or liquid market will ever develop for the shares of our common stock and warrants.

Because of the anticipated low price of the securities being registered, many brokerage firms may not be willing to effect transactions in these securities. Purchasers of our securities should be aware that any market that develops in our stock will be subject to the penny stock restrictions.

* * * * *

For all of the foregoing reasons and others set forth herein, an investment in our securities involves a high degree of risk.

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USE OF PROCEEDS

We estimate that the net proceeds from this offering will be approximately $_______________ based on assumed offering price of $______ per Unit, which was the last reported sale price of our common stock on the OTC Pink Market, on September ___, 2021,2022, after deducting estimated underwriting discounts and estimated offering expenses payable by us and excluding the proceeds, if any, from the exercise of the warrants issued as part of the Units. If the underwriters’ over-allotment option is exercised in full, we estimate that our net proceeds will be approximately $_________________ after deducting estimated underwriting discounts and estimated offering expenses payable by us and excluding the proceeds, if any, from the exercise of the warrants, based on an assumed offering price of $_______ per Unit, which was the last reported sale price of our common stock on the OTC Pink Market, on September ___, 2021.2022.

A $0.25 increase (decrease) in the assumed public offering price of $______ per Unit would increase (decrease) the expected net proceeds of the offering to us by approximately $_________ million, assuming that the number of Units sold by us remains the same. We may also increase or decrease the number of Units we are offering. An increase (decrease) of 100,000 in the number of Units sold in this offering would increase (decrease) the expected net proceeds of the offering to us by approximately $_________ million assuming that the assumed public offering price per share remains the same.

We intend to use the net proceeds fromof this offering for research and development andOffering to fund our current business operations, gain new regulatory approvals, enhance our current product, expand our sales and marketing expenses,efforts, and continue research into next generation technology. Our primary activities in orderthe near term will be focused on working to engage additional personnel,achieve FDA approval of our CBD inhaler products which are based on our proprietary blend of isolates, both in crystalline solid and powder form. We are planning to resume manufacturing and selling of our products only when we reach this highest level of regulatory acceptance, therefore, gaining FDA approval of these devices represents the foundational building block of our current business plans.

Seeking and obtaining FDA approval of our inhalers will be a time consuming and expensive undertaking and we do not expect to be in a position to achieve success in that regard before the end of 2023, at the earliest. Due to the many variables that will be involved in our planned FDA application and approval process, most of which do not lend themselves to being readily measured or quantified, we are presently unable to project our anticipated funding requirements with any degree of specificity. We believe it is conceivable that we could eventually expend a very substantial portion of the proceeds of this offering seeking such regulatory approvals and/or may need to seek out further funding to complete such process. Nonetheless, there can be no assurance that the FDA will ever approve our products.

Additionally, we plan to use approximately $784,760 of the proceeds from the offering to repay (a) unsecured cash advances from the Company’s Chief Executive Officer and Senior Vice President in May, June and July 2021 and April 2022, in the total amount of $283,000, which funds were used for general working capital purposes, and which funds accrue interest at the rate of 1% per annum, and are payable on demand; and (b) $501,760 owed under the Suggs Note which amount accrues interest at 18% per annum, compounded monthly (at the end of each month), until the earlier of (i) January 26, 2023 or (ii) ten days from the date that the Company’s common stock is listed on a national exchange and that the Company receives funding under any underwritten offering in connection therewith, which will include the offering contemplated by the registration statement of which this prospectus forms a part (the “Pre-Payment Date”), when all accrued interest and outstanding principal under the Suggs Note is required to be paid in a single lump sum, provided that if the Pre-Payment Date occurs prior to the maturity date, the Company is required to pay a prepayment penalty equal to the outstanding principal balance of the Suggs Note multiplied by 25.44% ($101,760), less the amount of total accrued interest owed under the Suggs Note as of the Pre-Payment Date (the “Pre-Payment Penalty”). Funds obtained in connection with the Suggs Note were used for general working capital. The Suggs Note is held by J. Scott Suggs, a member of our Board of Directors. We will be required to a pay a $42,000 Pre-Payment Penalty in connection with the repayment of the Suggs Note, which is included in the amount referenced above.

The remaining use of such proceeds, if any, will be used to fund working capital and general corporate purposes and possibly acquisitions of other companies, products or technologies.

This expected use of net proceeds from this offering represents our intentions based upon our current plans and business conditions. The amounts and timing of our actual expenditures may vary significantly depending on

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numerous factors. As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering. We may find it necessary or advisable to use the net proceeds from this offering for other purposes, and we will have broad discretion in the application of net proceeds from this offering.

Pending our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments and U.S. government securities.

DESCRIPTION OF SECURITIES WE ARE OFFERING

Units. We are offering ____________ Units, each Unit consists of one share of our common stock, par value $0.001 per share, and one warrant (the “Warrants”) to purchase one share of our common stock. The shares of our common stock and related Warrants will be issued separately. We are also registering the shares of our common stock issuable upon exercise of the Warrants offered hereby.

Common Stock. The material terms and provisions of our common stock are described in the section entitled “Description of Capital Stock-Common Stock” below.

Warrants. The material terms of the Warrants to be issued are summarized below. This summary does not purport to be complete in all respects. This description is subject to and qualified entirely by the terms of the form of Warrant filed as an exhibit to the registration statement of which this prospectus is a part.

Each Warrant is exercisable for one share of common stock at an exercise price of _____% of the price of each Unit sold in the offering and is exercisable at any time up for a period of five years following the date of issuance. We expect to have _____________ outstanding Warrants upon the completion of this offering (______________ outstanding warrants in the event that the underwriters’ exercise their overallotment option in full).

The number of Warrants outstanding, and the exercise price of those securities, will be adjusted proportionately in the event of a reverse or forward stock split of our common stock, a recapitalization or reclassification of our common stock, payment of dividends or distributions in common stock to our common stock holders, or similar transactions. In the event that the Company effects a rights offering to its common stock holders or a pro rata distribution of its assets among its common stock holders, then the holder of the Warrants will have the

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right to participate in such distribution and rights offering to the extent of their pro rata share of the Company’s outstanding common stock assuming they owned the number of shares of common stock issuable upon the exercise of their Warrants. In the event of a “Fundamental Transaction” by the Company, such as a merger or consolidation of it with another company, the sale or other disposition of all or substantially all of the Company’s assets in one or a series of related transactions, a purchase offer, tender offer or exchange offer, or any reclassification, reorganization or recapitalization of the Company’s common stock, then the Warrant holder will have the right to receive, for each share of common stock issuable upon the exercise of the Warrant, at the option of the holder, the number of shares of common stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration payable as a result of the Fundamental Transaction, that would have been issued or conveyed to the Warrant holder had the holder exercised the Warrant immediately preceding the closing of the Fundamental Transaction. In lieu of receiving such common stock and additional consideration in the Fundamental Transaction, the Warrant holder may elect to have the Company or the successor entity purchase the Warrant holder’s Warrant for its fair market value measured by the Black Scholes method.

The Company will promptly notify the Warrant holders in writing of any adjustment to the exercise price or to the number of the outstanding Warrants, declaration of a dividend or other distribution, a special non-recurring cash dividend on or a redemption of the common stock, the authorization of a rights offering, the approval of the stock holders required for any proposed reclassification of the common stock, a consolidation or merger by the Company, sale of all or substantially all of the assets of the Company, any compulsory share exchange, or the authorization of any voluntary or involuntary dissolution, liquidation, or winding up of the Company.

The Warrants contain a contractual provision stating that all questions concerning the construction, validity, enforcement and interpretation of the Warrants are governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law.

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Representative’s Warrants. We also expect to have up to an additional _____________ common stock purchase warrants outstanding after this offering (or ____________ common stock purchase warrants if the Units reserved for the over-allotment are sold), issuable to the underwriter of this offering (“Underwriter’s Warrants”). Each Underwriter’s Warrant is exercisable for one share of common stock on a cash or cashless basis at an exercise price of 120% of the price of each Unit share of sold in the offering). The Underwriter’s Warrants will be non-exercisable for six (6) months after the effective date (the “Effective Date”) of the registration statement of which this prospectus forms a part, and will expire five years after such Effective Date. The Underwriter’s Warrants will contain provisions for one demand registration of the shares underlying the Underwriter’s Warrants at the Company’s expense and one registration of the Underwriter’s Warrants at the Representative’s expense for a period of five years from the Effective Date, and unlimited piggyback registration rights for a period of five years after the Effective Date at the Company’s expense.

The number of Underwriter’s Warrants outstanding and the exercise price of those securities will be adjusted proportionately, as permitted by FINRA Rule 5110(f)(2)(G), in the event of a reverse or forward stock split of our common stock, a recapitalization or reclassification of our common stock, payment of dividends or distributions in common stock to our common stock holders, or similar transactions. In the event that the Company effects a rights offering to its common stock holders or a pro rata distribution of its assets among its common stock holders, then the holder of the Underwriter’s Warrants will have the right to participate in such distribution and rights offering to the extent of their pro rata share of the Company’s outstanding common stock assuming they owned the number of shares of common stock issuable upon the exercise of their warrants. In the event of a “Fundamental Transaction” by the Company, such as a merger or consolidation of it with another company, the sale or other disposition of all or substantially all of the Company’s assets in one or a series of related transactions, a purchase offer, tender offer or exchange offer, or any reclassification, reorganization or recapitalization of the Company’s common stock, then the warrant holder will have the right to receive, for each share of common stock issuable upon the exercise of the warrant, at the option of the holder, the number of shares of common stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration payable as a result of the Fundamental Transaction that would have been issued or conveyed to the warrant holder had the holder exercised the warrant immediately preceding the closing of the Fundamental Transaction. In lieu of receiving such common stock and additional consideration in the Fundamental Transaction, the warrant holder may elect to have the Company or the successor entity purchase the warrant holder’s warrant for its fair market value measured by the Black Scholes method.

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The Company will promptly notify the holders of the Underwriter’s Warrants in writing of any adjustment to the exercise price or to the number of the outstanding warrants, declaration of a dividend or other distribution, a special non-recurring cash dividend on or redemption of the common stock, the authorization of a rights offering, the approval of the stock holders required for any proposed reclassification of the common stock, a consolidation or merger by the Company, sale of all or substantially all of the assets of the Company, any compulsory share exchange, or the authorization of any voluntary or involuntary dissolution, liquidation, or winding up of the Company.

DETERMINATION OF THE OFFERING PRICE

The public offering price of the Units offered by this prospectus was determined by careful consideration of our management and our Board of Directors, based upon discussions with our underwriters. In addition, our management and our Board of Directors considered discussions with, and advice provided by, independent brokers and investors relating to their opinions of the price at which we could succeed in attracting investors for this offering. We cannot provide assurances that we will succeed in attracting any investors at the public offering price of the Units offered by this prospectus, that the public offering price is in fact reflective of the true value of the Units, our common stock and/or warrants, or of us, or that the markets will react positively following any such offers and sales by us of our Units. See “Underwriting.”

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DIVIDEND POLICY

We have never paid or declared any cash dividends on our common stock and do not anticipate paying cash dividends in the foreseeable future. We anticipate that we will retain all of our future earnings for use in the operation of our business and for general corporate purposes. Any determination to pay dividends in the future will be at the discretion of our Board of Directors. Accordingly, investors must rely on sales of their common stock after price appreciation, which may never occur, as the only way to realize any future gains on their investments.

CAPITALIZATION

The following table shows our capitalization:

·as of June 30, 2021,March 31, 2022, on an actual basis;  

·as of June 30, 2021,March 31, 2022, on a pro forma basis, to reflect the sale, on August 4, 2021,May 31, 2022, of an Original Issue Discount Convertible Debenture in the original principal amount of $1,941,176 (the “ Debenture ”)$411,764 and the grant of warrants to purchase up to 4,852,940388,235 shares of common stock with an exercise price of the Company;$10.00 per share; and 

·on a pro forma, as adjusted basis, to reflect the receipt of the net proceeds from the sale by us in this offering of Units, after deducting $______________ in estimated underwriting discounts and commissions and estimated offering expenses payable by us. 

We derived this table from, and it should be read in conjunction with and is qualified in its entirety by reference to, our historical and unaudited pro forma consolidated financial statements and the accompanying notes included elsewhere in this prospectus. You should also read this table in conjunction with “Selected Historical Consolidated Financial and Operating Data” and “Management’sManagement’s Discussion and Analysis of Financial Condition and Results of Operations.” The information below is in thousands, except share and per share amounts.

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(1)The pro forma gives effect to the sale in this offering of _______________ Units at an assumed public offering price of $_______ per share, which was the last reported sale price of our common stock on the OTC Pink Market, , on September ___, 2021,2022, after deducting the underwriting discounts and commissions and estimated offering expenses. 

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(2)The number of shares of common stock to be outstanding after the offering: 

·assumes no exercise by the representative of the underwriters of its option to purchase up to an additional ______________ shares of common stock and/or warrants to cover over-allotments, if any; 

·assumes no exercise of warrants sold in this offering as part of the Units; 

·excludes 8,204,337920,232 shares of our common stock issuable upon the exercise of warrants with exercise prices ranging from $0.40$10.00 to $1.00$25.00 per share;  

share, with a weighted average exercise price of $13.02 per share (which includes warrants to purchase 388,235 shares of common stock which were issued after March 31, 2022); 

·excludes shares of common stock issuable upon conversion of outstanding convertible promissory notes, of which convertible notes in the aggregate amount of approximately $2,116,000, which have conversion prices between $0.05$1.25 per share and $0.40;  

$10.00; 

·assumes no further awards under the Company’s equity compensation plans (after June 30, 2021)March 31, 2022);

·excludes the issuance of any shares of Series A Convertible Preferred Stock, Series B Convertible Preferred Stock (of which a total of 1 million shares of Series B Preferred Stock have been earned, but not issued, as of the date of this prospectus) or Series C Convertible Preferred Stock, which if issued and earned, will be convertible for common stock on a one-for-one1-for-25 basis; and 

·assumes no exercise of the Representative’s Warrants. 

A $0.25 increase (decrease) in the assumed public offering price of $______ per Unit, which was the last reported sale price of our common stock on the OTC Pink Market, , on September ___, 2021,2022, would increase (decrease) the expected net proceeds of the offering to us by approximately $_________ million, assuming that the number of Units sold by us remains the same. We may also increase or decrease the number of Units we are offering. An increase (decrease) of 100,000 in the number of Units sold in this offering would increase (decrease)

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the expected net proceeds of the offering to us by approximately $_________ million assuming that the assumed public offering price per share remains the same.

A $0.25 increase (decrease) in the assumed public offering price of $_____ per Unit, , which was the last reported sale price of our common stock on the OTC Pink Market,, on September ___, 2021,2022, would result in an incremental increase (decrease) in the pro forma as adjusted amount of each of our additional paid-in capital and total stockholders’ equity by approximately $________ million, assuming that the number of Units sold by us as set forth on the cover page of this prospectus remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

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DILUTION

The following table sets forth our cash and cash equivalents and capitalization as of June 30, 2021March 31, 2022 as follows:

·on an actual basis;  

·as of June 30, 2021,March 31, 2022, on a pro forma basis, to reflect the sale, on August 4, 2021,May 31, 2022, of an Original Issue Discount Convertible Debenture in the original principal amount of $1,941,176$411,764 and the grant of warrants to purchase up to 4,852,940388,235 shares of common stock with an exercise price of the Company;$10.00 per share; and 

·on a pro forma, as adjusted basis, giving effect to our issuance and sale of $___________________ Units in this offering at an assumed public offering price of $_______ per Unit, which was the last reported sale price of our common stock on the OTC Pink Market,, on September ___, 2021,2022, and after deducting estimated underwriting discounts and commissions and estimated offering expenses. 

If you invest in our Units in this offering, your interest will be diluted to the extent of the difference between the public offering price per share of our common stock that is part of the Unit and the pro forma, as adjusted, net tangible book value per share of our common stock immediately after this offering.

The net tangible book value of our common stock as of June 30, 2021March 31, 2022 was $226,417$(3,345,420) or approximately $0.00$(0.43) per share. Net tangible book value per share represents our total tangible assets less our total tangible liabilities, divided by the number of shares of common stock, as of June 30, 2021.March 31, 2022.

The pro forma net tangible book value of our common stock as of June 30, 2021,March 31, 2022, after the sale, on August 4, 2021,May 31, 2022, of an Original Issue Discount Convertible Debenture in the original principal amount of $1,941,176 and a warrant to purchase up to 4,852,940 shares of common stock of the Company$411,764 was ($64,759)3,577,259) or approximately ($0.00)0.46) per share. Net tangible book value per share represents our total tangible assets less our total tangible liabilities, divided by the number of shares of common stock, as of JuneMarch 30, 2021.2022.

Pro forma, net tangible, as adjusted, book value dilution per share to new investors represents the difference between the amount per Unit paid by purchasers in this offering and the pro forma net tangible book value per share of our common stock immediately after the completion of this offering. After giving effect to our issuance and sale of $______________ Units in this offering at the assumed public offering price of $_______ per Unit, which was the last reported sale price of our common stock on the OTC Pink Market,, on September ___, 2021,2022, and after deducting estimated underwriting discounts and commissions and estimated offering expenses, our pro forma, as adjusted, net tangible book value as of June 30, 2020March 31, 2022, would have been $_______ per share. This represents an immediate increase in net tangible, as adjusted, book value of $_______ per share to existing stockholders and an immediate dilution in net tangible, as adjusted, book value of $_______ per share to purchasers of Units in this offering.

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The following table illustrates this per share dilution to investors participating in this offering:

A $0.25 increase (decrease) in the assumed public offering price of $________ per share would result in an incremental increase (decrease) in our pro forma as adjusted net tangible book value of approximately $_________ million or approximately $________ per share, and would result in an incremental increase (decrease) in the dilution to new investors of approximately $_____ per share, assuming that the number of Units sold by us remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

We may also increase or decrease the number of Units we are offering from the assumed number of Units set forth above. An increase (decrease) of 100,000 in the assumed number of Units sold by us in this offering would result in an incremental increase (decrease) in our pro forma as adjusted net tangible book value of approximately $_______ million or approximately $_____ per share, and would result in an incremental increase (decrease) in the dilution to new investors of $_______ per share, assuming that the assumed public offering price of the Units remains the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. An increase (decrease) of 250,000 in the assumed number of Units sold by us in this offering would result in an incremental increase (decrease) in our pro forma as adjusted net tangible book value of approximately $________ million or approximately $_______ per share, and would result in an incremental increase (decrease) in the dilution to new investors of $_____ per share, assuming that the assumed public offering price of the Units remains the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. The information discussed above is illustrative only and will adjust based on the actual public offering price, the actual number of securities in this offering and other terms of this offering determined at pricing. The information discussed above is illustrative only and will adjust based on the actual public offering price, the actual number of securities in this offering and other terms of this offering determined at pricing.

The foregoing discussion and table do not take into account further dilution to new investors that could occur upon the exercise of outstanding warrants having a per share exercise or conversion price less than the per share offering price to the public in this offering.

The number of shares of common stock to be outstanding after the offering:

·assumes no exercise by the representative of the underwriters of its option to purchase up to an additional ______________ shares of common stock and/or warrants to cover over-allotments, if any; 

·assumes no exercise of warrants sold in this offering as part of the Units; 

·excludes 8,204,337920,232 shares of our common stock issuable upon the exercise of warrants with exercise prices ranging from $0.40$10.00 to $1.00$25.00 per share;  

share, with a weighted average exercise price of $13.02 per share (which includes warrants to purchase 388,235 shares of common stock which were issued after March 31, 2022); 

·excludes shares of common stock issuable upon conversion of outstanding convertible promissory notes, of which convertible notes in the aggregate amount of approximately $2,116,000, which have conversion prices between $0.05$1.25 per share and $0.40;  

$10.00; 

·assumes no further awards under the Company’s equity compensation plans (after JuneMarch 30, 2021)2022);

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·excludes the issuance of any shares of Series A Convertible Preferred Stock, Series B Convertible Preferred Stock (of which a total of 1 million shares of Series B Preferred Stock have been earned, but not issued, as of the date of this prospectus) or Series C Convertible Preferred Stock, which if issued and earned, will be convertible for common stock on a one-for-one1-for-25 basis; and; and

·assumes no exercise of the Representative’s Warrants. 

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS

ON ACCOUNTING AND FINANCIAL DISCLOSURE

Effective March 27, 2020, the Board of Directors dismissed Prager Metis CPAs LLP (“Prager”) as the Company's independent registered public accounting firm. The Company’s Board of Directors recommended and approved the engagement by the Company of PWR CPA, LLP (“PWR”) to serve as the Company’s independent registered public accounting firm, effective March 27, 2020.None.

The report of Prager on the financial statements of the Company as of and for the fiscal year ended March 31, 2019, contained no adverse opinion or disclaimer of opinion and was not qualified or modified as to uncertainty, audit scope, or accounting principles. Prager was not the Company’s independent registered public accounting firm during the year ended March 31, 2018.

During the Company’s fiscal year ended March 31, 2019, and the subsequent interim period from April 1, 2019 to the dismissal of Prager, there were no disagreements between the Company and Prager on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to the satisfaction of Prager, would have caused Prager to make reference to the subject matter of such disagreements in connection with its audit reports on the Company's financial statements.

During the Company’s fiscal year ended March 31, 2019, and the subsequent interim period from April 1, 2019 to the dismissal of Prager, there were no reportable events within the meaning of Item 304(a)(1)(v) of Regulation S-K.

During the Company’s fiscal years ended March 31, 2019 and 2018, and the subsequent interim period from April 1, 2019 to engagement of PWR, the Company did not consult with PWR regarding any of the matters set forth in Items 304(a)(2)(i) and (ii) of Regulation S-K.

MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS

Reverse Stock Split

On March 4, 2022, the Board of Directors approved a stock split ratio of 1-for-25 in connection with the Shareholder Authority, provided that such approval was subject in all cases to approval of such Reverse Stock Split by the Financial Industry Regulatory Authority (FINRA), and the filing of an amendment to the Articles of Incorporation of the Company with the Secretary of State of Nevada. On March 29, 2022, the Company filed a Certificate of Amendment to the Company’s Articles of Incorporation with the Secretary of Nevada to affect the Reverse Stock Split and the Authorized Share Increase, which became effective at 2:00:01 A.M., Central Standard Time, on March 31, 2022. The effects of the 1-for-25 Reverse Stock Split has been retroactively reflected throughout the registration statement, of which this prospectus forms a part.

Market Information

Our common stock is presently quoted on the OTC Pink Market, under the symbol “RTSL”. At present, there is a very limited market for our common stock. The OTC Market is a network of security dealers who buy and sell stock. The dealers are connected by a computer network that provides information on current “bids” and “asks”, as well as volume information.

We plan to applyhave applied to list our common stock and warrants on the Nasdaq Capital Market under the symbols “RTSL” and “RTSL WS”, respectively. The approval of our listing of our common stock and warrants on the Nasdaq Capital Market is a condition of closing this offering. No assurance can be given that our applications will be accepted.

The following table sets forth the range of high and low sales prices for our common stock for each of the periods indicated as reported by the OTC Pink Market. These quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not necessarily represent actual transactions. All sales prices described below have been retroactively adjusted for the 1-for-25 reverse stock split of our common stock which was effective March 31, 2022.

Nine Month Transition Period Ending December 31, 2020

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Fiscal Year Ended March 31, 2019

Fiscal Year Ended March 31, 2020

Nine Month Transition Period Ending December 30, 2020

Fiscal Year Ending December 31, 2021

* No trades during the applicable quarter.Fiscal Year Ending December 31, 2022

On September [___], 2021,July 22, 2022, the closing price for our common stock on the OTC Pink Market was $[_____]$2.15 per share with respect to an insignificant volume of shares.

The volume of shares traded on the OTC Pink Market was insignificant and therefore, does not represent a reliable indication of the fair market value of these shares.

Holders

According to the records of our transfer agent, as of September [___], 2021,July 22, 2022, there were approximately 140 record holders of our common stock. The number of record holders does not include beneficial owners of common stock whose shares are held in the names of banks, brokers, nominees or other fiduciaries.

Dividends

We have never paid any cash dividends on our common stock. We currently anticipate that we will retain all future earnings for use in our business. Consequently, we do not anticipate paying any cash dividends in the foreseeable future. The payment of dividends in the future will depend upon our results of operations, as well as our short term and long-term cash availability, working capital, working capital needs, and other factors as determined by our Board of Directors. Currently, except as may be provided by applicable laws, there are no contractual or other restrictions on our ability to pay dividends if we were to decide to declare and pay them.

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Our Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is provided in addition to the accompanying consolidated financial statements and notes to assist readers in understanding our results of operations, financial condition, and cash flows. MD&A is organized as follows:

·Forward Looking Statements. A description of certain factors which might cause future events discussed herein to not come to fruition.  

·Results of Operations. An analysis of our financial results comparing the three and six months ended June 30,March 31, 2022 and 2021, and 2020 andthe year ended December 31, 2021, compared to the nine month transition period ended December 31, 2020, compared to the nine-month period ended December 31, 2019, and the year ended March 31, 2020 and for the fiscal years ended March 31, 2020 and 2019.  

2020.  

·Liquidity and Capital Resources. A discussion of our financial condition, including descriptions of balance sheet information and cash flows.  

·Plan of Operations. A description of our plan of operations for the next 12 months including required funding. 

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·Critical Accounting Policies and Estimates. Accounting estimates that we believe are important to understanding the assumptions and judgments incorporated in our reported financial results and forecasts.  

Forward Looking Statements

The following discussion should be read in conjunction with our consolidated financial statements and accompanying notes included elsewhere in this prospectus. The following discussion contains forward looking statements regarding future events and the future results of the Company that are based on current expectations, estimates, forecasts, and projections about the industry in which the Company operates and the beliefs and assumptions of the management of the Company. Words such as “expects,” “anticipates,” “targets,” “goals,” “projects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words, and similar expressions are intended to identify such forward looking statements. These forward-looking statements are only predictions and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, those discussed elsewhere in this prospectus, particularly under “Risk Factors,” and in other reports we file with the SEC. The Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this prospectus.

The following discussion is based upon our Consolidated Financial Statements included elsewhere in this prospectus, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingencies. In the course of operating our business, we routinely make decisions as to the timing of the payment of invoices, the collection of receivables, the shipment of products, the fulfillment of orders, the purchase of supplies, and the building of inventory, among other matters. Each of these decisions has some impact on the financial results for any given period. In making these decisions, we consider various factors including contractual obligations, customer satisfaction, competition, internal and external financial targets and expectations, and financial planning objectives. On an on-going basis, we evaluate our estimates, including those related to sales returns, allowance for doubtful accounts, impairment of long-term assets, especially goodwill and intangible assets, assumptions used in the valuation of stock-based compensation, and litigation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Reverse Stock Split

On March 4, 2022, the Board of Directors approved a stock split ratio of 1-for-25 in connection with the Shareholder Authority, provided that such approval was subject in all cases to approval of such Reverse Stock Split by the Financial Industry Regulatory Authority (FINRA), and the filing of an amendment to the Articles of Incorporation of the Company with the Secretary of State of Nevada. On March 29, 2022, the Company filed a Certificate of Amendment to the Company’s Articles of Incorporation with the Secretary of Nevada to affect the Reverse Stock Split and the Authorized Share Increase, which became effective at 2:00:01 A.M., Central Standard Time, on March 31, 2022. The effects of the 1-for-25 Reverse Stock Split have been retroactively reflected throughout the registration statement, of which this prospectus forms a part.

Results of Operations

The following selected consolidated financial data should be read in conjunction with the consolidated financial statements and the notes to these statements included in this prospectus. For all periods presented, the

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consolidated statements of income and consolidated balance sheet data set forth in this prospectus have been adjusted for the reclassification of discontinued operations information, unless otherwise noted.

On February 16, 2021, our Board of Directors approved a change in our fiscal year end from March 31 to December 31. As such, the financial information and certain of the other disclosures herein, where indicated, are presented for the nine-month transition period ended December 31, 2020, the nine monthsyear ended December 31, 2019, for2021, and the fiscal yearthree months ended March 31, 2020,2022 and for the three and six months ended June 30, 2021.

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Results of Operations for the Three and Six Months Ended June 30, 2021March 31, 2022 Compared to 20202021

The following discussion reflects the Company’s revenues and expenses for the three and six month periods ended June 30,March 31, 2022 and 2021, and 2020, as reported in our consolidated financial statements included herein, beginning on page 86.

Three months ended June 30, 2021 versus three months ended June 30, 2020herein.

Revenues- The Company commenced limited sales of its inhaler products to customers, while still in a product development mode, on a trial basis in January 2020.  However, due to the subsequent impact of the COVID 19 pandemic, as well as other contributing factors, the Company has currently suspended such sales and had no sales for the three months ended March 31, 2022 or 2021.

General and Administrative Expense - General and administrative expenses for the three months ended March 31, 2022 were $762,141 compared to $501,923 in the three months ended March 31, 2021.  This increase was due to higher level corporate expenses incurred in seeking an uplisting of the Company’s common stock on a national securities exchange as well as to various regulatory and other related expenses incurred in pursuing a new drug application with the FDA and for certain other clinical-oriented initiatives.  We expect the level of both types of expenses to generally rise in comparison to prior year amounts in the foreseeable future.

Amortization Expense - Amortization expense for the three months ended March 31, 2022 was $21,259, compared to $12,500 in the three months ended March 31, 2021.  This increase was due to the amortization expense recognized in the three months ended March 31, 2022 on an operating lease asset beginning in October 2021, which was partially offset by amortization expense recorded in the three months ended March 31, 2021 related to the Sublicense Agreement, which was terminated effective February 9, 2021, under which the Company had been obligated to reimburse TMDI in the amount of $200,000 for a license fee owed by TMDI to EM3, covering the first two years of the Sublicense Agreement, as discussed in greater detail above.

Depreciation Expense - Depreciation expense for the three months ended March 31, 2022 was $5,993, compared to $5,525 in the three months ended March 31, 2021.  This increase reflects the rising depreciation level on the Company’s purchases of property and equipment beginning in September 2020.

Other Income (Expense) - Interest expense for the three months ended March 31, 2022 was $713,313, compared to $13,798 in the three months ended March 31, 2021.  This increase was due to the amortization of the original issue debt discount and other adjustments to interest expense arising from the warrant liability recognized from the issuance of common stock warrants issued in conjunction with a convertible debenture in August 2021.  Other income (expense) also includes a loss from the change in valuation of the warrant liability in the quarter ended March 31, 2022 of $77,045.

Net Loss - Net loss for the three months ended March 31, 2022 was $1,579,751, compared to $533,746 in the three months ended March 31, 2021, representing the net amounts of the various revenue and expense categories indicated above. The Company has not recognized any income tax benefits for these net losses due to the uncertainty of their ultimate realization.

Results of Operations for the Year Ended December 31, 2021, Compared to the Nine-Month Transition Period Ended December 31, 2020

The following discussion pertains to the Company’s revenues and expenses for the year ended December 31, 2021 and the nine-month transition period ended December 31, 2020, as reported in our consolidated financial statements and notes thereto included herein.

Revenues - The Company commenced limited sales of its inhaler products to customers, while still in a product development mode, on a trial basis in January 2020.  However, due to the subsequent impact of the COVID-19 pandemic, as well as other contributing factors, the Company has not sustained a consistent level of sales thus far. The Company has two different sales channels in trial mode as follows:

·Wholesale - designed to capture fairly large, but sporadic, orders received from wholesale customers, often for substantial quantities with relatively high profit margins. 

·Retail - designed to capture a high volume of small orders received from retail customers through an online portal, with significantly lower profit margins. 

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The revenues from such sales on a trial basis in the three monthsyear ended June 30,December 31, 2021 were $424,$534 compared to $129,287,$130,916 for the nine-month transition period ended December 31, 2020, consisting mostlymainly of two large wholesale orders, in the three months ended June 30, 2020.orders.  Revenues from sales of the Company’s inhaler and other products, under both trial sales channels, are expected to gradually increase in the future, once the current trial period ends.

Cost of Goods Sold- Cost of goods sold forin the three monthsyear ended June 30,December 31, 2021 were $200 compared to $18,556$19,394 in the three monthsnine-month transition period ended June 30,December 31, 2020.  The cost of goods sold in both periods reflected the cost of procuring inhalers and related products and supplies for resale andresale.  The cost of goods sold in the year ended December 31, 2021 was not relevant due to the very low level of sales in that period, whereas the cost of goods sold in the nine months ended December 31, 2020, resulted in a gross profit percentagesmargin of revenues of approximately 53% and 85%, for the three months ended June 30, 2021 and 2020, respectively. The greater gross profit percentage in the three months ended June 30, 2020 reflected a relatively large portion of sales to two higher profit wholesale customers.$111,522.

General and Administrative Expense- General and administrative expenses forin the three monthsyear ended June 30,December 31, 2021 were $527,278$2,114,770 compared to $629,510$2,023,379 in the three monthsnine-month transition period ended June 30,December 31, 2020.  This net decrease of $102,232 consisted of two components: (i) anfluctuation was due to the increase of $237,352 in certain cash overhead expenses, mostly for payroll, arising from the adoption of a new business strategy focused on commercial opportunities involving the rapid application of therapeutics using the Rxoid^TMMDI technology, supplemented by the assets recently acquired from Razor Jacket; and (ii) a decrease of $339,584Jacket, LLC (“Razor Jacket”) in non-cash stock compensation expenses for restricted stock grants due to the fact that that the initial grants were made to various consultants in the three months ended June 30, 2020 whereas no such grants were made in the three months ended June 30, 2021.late 2020.

Amortization Expense- Amortization expense forin the three monthsyear ended June 30,December 31, 2021 was zero$33,759 compared to $25,000$75,000 in the three monthsnine-month transition period ended June 30,December 31, 2020.  This decrease was largely due to the termination of the Sublicense Agreement, effective February 9, 2021, under which the Company was previously obligated to reimburse TMDI in the amount of $200,000 for a license fee owed by TMDI to EM3, covering the first two years of the Sublicense Agreement, as discussed in greater detail above.in the section above, partially offset by the initial amortization expense recognized on an operating lease asset beginning in October 2021.

Depreciation Expense- Depreciation expense forin the three monthsyear ended June 30,December 31, 2021 was $5,525,$22,100 compared to zero$7,255 in the three monthsnine-month transition period ended June 30,December 31, 2020.  This increase reflects depreciation on the Company’s initial purchases of property and equipment beginning in September 2020.

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Interest Expense - Interest expense for the three months ended June 30, 2021 was $3,309, compared to $22,601 in the three months ended June 30, 2020. This decrease was due to a lower level of outstanding borrowings following the conversion of certain convertible notes payable into common stock, in August 2020 and March 2021.

Net Loss - Net loss for the three months ended June 30, 2021 was $535,888, compared to $566,380 in the three months ended June 30, 2020, representing the net amounts of the various revenue and expense categories indicated above. The Company has not recognized any income tax benefits for these net losses due to the uncertainty of their ultimate realization.

Six months ended June 30, 2021 versus six months ended June 30, 2020

Revenues - The Company commenced limited sales of its inhaler products to customers, while still in a product development mode, on a trial basis in January 2020.  However, due to the subsequent impact of the COVID 19 pandemic, as well as other contributing factors, the Company has not sustained a consistent level of sales thus far.  The Company has two different sales channels in trial mode as follows:

·Wholesale - designed to capture fairly large, but sporadic, orders received from wholesale customers, often for substantial quantities with relatively high profit margins.  

·Retail - designed to capture a high volume of small orders received from retail customers through an online portal, with significantly lower profit margins.  

The revenues from such sales on a trial basis in the six months ended June 30, 2021, were $424, compared to $138,426, consisting mostly of two large wholesale orders, in the six months ended June 30, 2020. Revenues from sales of the Company’s inhaler products, under both trial sales channels, are expected to gradually increase in the future, once the current trial period ends.

Cost of Goods Sold - Cost of goods sold for the six months ended June 30, 2021 were $200 compared to $25,711 in the six months ended June 30, 2020. The cost of goods sold in both periods reflected the cost of procuring inhalers and related products and supplies for resale and resulted in gross profit percentages of approximately 53% and 81%, for the six months ended June 30, 2021 and 2020, respectively. The greater gross profit percentage in the six months ended June 30, 2020 reflected a relatively large portion of sales to two higher profit wholesale customers.

General and Administrative Expense - General and administrative expenses for the six months ended June 30, 2021 were $1,029,201 compared to $853,750 in the six months ended June 30, 2020. This net increase of $175,451 consisted of two components: (i) an increase of $615,035 in cash overhead expenses, mostly for payroll, arising from the adoption of a new business strategy focused on commercial opportunities involving the rapid application of therapeutics using the Rxoid ^TM MDI technology supplemented by the assets recently acquired from Razor Jacket; and (ii) a decrease of $439,584 in non-cash stock compensation expenses for restricted stock grants due to the fact that that the initial grants were made to various consultants in the six months ended June 30, 2020 whereas no such grants were made in the six months ended June 30, 2021.

Amortization Expense - Amortization expense for the six months ended June 30, 2021 was $12,500 compared to $50,000 in the six months ended June 30, 2020. This decrease was due to the termination of the Sublicense Agreement, effective February 9, 2021, under which the Company was previously obligated to reimburse TMDI in the amount of $200,000 for a license fee owed by TMDI to EM3, covering the first two years of the Sublicense Agreement, as discussed in greater detail above.

Depreciation Expense - Depreciation expense for the six months ended June 30, 2021 was $11,050, compared to zero in the six months ended June 30, 2020. This increase reflects depreciation on the Company’s initial purchases of property and equipment beginning in September 2020.

Interest Expense Other Income (Expense)- Interest expense forin the six monthsyear ended June 30,December 31, 2021 was $17,107,$1,329,441 compared to $86,493$58,009 in the six monthsnine-month transition period ended June 30,December 31, 2020. This decreaseincrease was due to the amortization of the original issue debt discount and other adjustments to interest expense arising from the warrant liability recognized from the issuance of common stock warrants issued in conjunction with a lower level of outstanding borrowings followingconvertible debenture in August 2021, partially offset by the conversion of certain convertible notes payable into common stock in August 2020 and March 2021.

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Net Loss - Net loss for the six months ended June 30, 2021 was $1,069,634, compared to $877,528warrant liability in the six months ended June 30, 2020, representing the net amounts of the various revenue and expense categories indicated above. The Company has not recognized any income tax benefits for these net losses due to the uncertainty of their ultimate realization.

Results of Operations for the Nine Month Transition Periodyear ended December 31, 2020, Compared to the Nine-Month Period Ended December 31, 2019, and the Year Ended March 31, 2020

The following discussion reflects the Company’s revenues and expenses for the nine-month transition period ended December 31, 2020, compared to the nine-month period ended December 31, 2019, and the year ended March 31, 2020, as reported in our consolidated financial statements included herein, beginning on page 90.2021 of $631,853.

Revenues - The Company commenced sales of its inhaler products to customers in January 2020.  The Company has two different sales channels as follows:

·Wholesale - designed to capture fairly large, but sporadic, orders received from wholesale customers, often for substantial quantities with relatively high profit margins. 

·Retail - designed to capture a high volume of small orders received from retail customers through an online portal, with significantly lower profit margins. 

The revenues from such sales in the nine-month transition period ended December 31, 2020 were $130,916, consisting largely of two large wholesale orders, compared to $0 for the nine months ended December 31, 2019, and $9,139 for the year ended March 31, 2020, consisting mostly of small retail orders.  We believe revenues from sales of the Company’s inhaler products, under both sales channels, are expected to gradually increase in the future due to our planned changes in our marketing strategy, however, our strategy was delayed due to the COVD-19 pandemic.

Cost of Goods Sold - Cost of goods sold for the nine-month transition period ended December 31, 2020, were $19,394 compared to $0 for the nine months ended December 31, 2019, and $7,155 for the year ended March 31, 2020. The cost of goods sold in the nine months ended December 31, 2020 period reflected the cost of procuring inhalers and related products and supplies for resale and resulted in a gross profit of $111,522, and a gross profit as a percentage of revenues of approximately 85%, reflecting a relatively large portion of sales to higher profit wholesale customers. We had no gross profit for the nine months ended December 31, 2019. For the year ended March 31, 2020, gross profit was $1,984 or 22% of sales.

General and Administrative Expense - General and administrative expenses for the nine-month transition period ended December 31, 2020, were $2,023,379, compared to $173,347 for the nine months ended December 31, 2019, and $397,487 for the year ended March 31, 2020. This fluctuation was due an increase of approximately $1.5 million in cash overhead costs following the Company’s recent adoption of a new business strategy focused on developing potential commercial opportunities which will involve the rapid application of therapeutics using the Rxoid^TM MDI technology that was being sublicensed from TMDI during the nine months ended December 31, 2020, and has since been licensed directly by its owner. Also included in general and administrative expenses for the nine months ended December 31, 2020 and the year ended March 31, 2020, were non-cash stock compensation expenses for restricted stock grants to various consultants in the amounts of $357,834 and $178,833, respectively.

Amortization Expense - Amortization expense for the nine-month transition period ended December 31, 2020 was $75,000, compared to $12,500 for the nine months ended December 31, 2019, and $37,500 for the year ended March 31, 2020. This increase was due to the Company’s quarterly amortization of its obligation to reimburse TMDI in the amount of $200,000 for a license fee owed by TMDI to a third-party licensor covering the first two years of the sublicense agreement, which has since been replaced by a royalty-free, perpetual license directly with the owner of the technology.

Depreciation Expense - Depreciation expense for the nine-month transition period ended December 31, 2020, was $7,255, compared to zero for the nine months ended December 31, 2019 and the year ended March 31, 2020.  This increase reflects the Company’s initial purchase of property and equipment in the nine-month transition period ended December 31, 2020, and the depreciation associated therewith.

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Interest Expense - Interest expense for the nine-month transition period ended December 31, 2020 was $58,009, compared to $127,689 for the nine months ended December 31, 2019, and $191,581 for the year ended March 31, 2020.  This decrease was due to a lower level of outstanding borrowings following the conversion of certain convertible notes payable into common stock in November 2019 and again in August 2020.

Net Loss - Net loss forin the year ended December 31, 2021 was $2,867,883 compared to $2,052,121 in the nine-month transition period ended December 31, 2020 was $2,052,121, compared to $313,436 for the nine months ended December 31, 2019, and $624,584 for the year ended March 31, 2020, representing the net amounts of the various revenue and expense categories indicated above. The Company has not recognized any income tax benefits for these net losses due to the uncertainty of their ultimate realization. Net loss increased mainly due to the increase in general and administrative expenses for the nine months ended December 31, 2020, offset by the increase in revenues and decrease in interest expense.

Results of Operations for the fiscal years ended March 31, 2020 and 2019

The following discussion pertains to the Company’s operating and other expenses for the years ended March 31, 2020 and 2019, as reported in our consolidated financial statements and notes thereto included herein, beginning on page 90.

Revenues - The Company commenced online sales of its inhaler products in January 2020.  The initial revenues from such sales in the year ended March 31, 2020 were $9,139 compared to zero for the year ended March 31, 2019.  We believe revenues from sales of the Company’s inhaler products, under both sales channels, are expected to gradually increase in the future due to our planned changes in our marketing strategy, however, our strategy was delayed due to the COVD-19 pandemic.

Cost of Goods Sold - Cost of goods sold for the year ended March 31, 2020, were $7,155 compared to zero for the year ended March 31, 2019.  The cost of goods sold in the fiscal 2020 period reflected the initial cost of procuring inhalers and related products and supplies for resale and resulted in gross profit of approximately 22%.

General and Administrative Expense - General and administrative expenses for the year ended March 31, 2020 were $397,487 compared to $169,690 for the year ended March 31, 2019.  This increase was due to the higher level of overhead costs following the Company’s recent adoption of a new business strategy focused on developing potential commercial opportunities which will involve the rapid application of therapeutics using the Rxoid^TM MDI technology.

Amortization Expense - Amortization expense for the year ended March 31, 2020 was $37,500 compared to zero for the year ended March 31, 2019. This increase was due to the Company’s initial amortization of its obligation to reimburse TMDI in the amount of $200,000 for a license fee owed by TMDI to a third-party licensor covering the first two years of the sublicense agreement, which as of February 9, 2021, is no longer payable.

Interest Expense - Interest expense for the year ended March 31, 2020 was $191,581 compared to $180,531 for the year ended March 31, 2019. This increase was due to more days of outstanding borrowings in current year relative to prior year.

Other - Gain on sale of Bitcoin for the year ended March 31, 2020 was zero compared to $1,380 for the year ended March 31, 2019. This decrease was due to the non-recurring sale of all of the Company’s internally-generated Bitcoin in November 2018.

Liquidity and Capital Resources

CashFlows

Cash flows fromOperating activities.activities.  Net cash used in operating activities forin the six monthsyear ended June 30,December 31, 2021 was $946,449,$2,209,131 compared to $369,009$1,724,829 in the six monthsnine-month transition period ended June 30,December 31, 2020.  This net increase was largely due to the higher level of overhead costs and buildup of product inventory levelsother working capital changes following the Company’s adoption of a new business strategy in early 2020, as further noted above.

Cash flows from Investing activitiesactivities. . Net cash used in investing activities forin the six monthsyear ended June 30,December 31, 2021 was $39,779$292,531 compared to zero$106,740 in the six monthsnine-month transition period ended June 30,December 31, 2020.  This increase was due to the Company’s greater level of purchases of property and equipment which began in September 2020.

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