UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 FORM

Form 10-K

(Mark One)

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended: December 31 2016

, 2022

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

For the transition period from _____________ to _____________

Commission File Number: 333-183360

EXACTUS, INC.
001-38190

Panacea Life Sciences Holdings, Inc.

(Exact name of registrant as specified in its charter)

Nevada
27-1085858
(State or other jurisdiction of(I.R.S. Employer
incorporation or organization)
27-1085858
(I.R.S. Employer Identification No.)
4870 Sadler Road, Suite 300
Glen Allen, Virginia
(Address of principal executive offices)
23060
(Zip Code)
(804) 205-5036

5910 S University Blvd, C18-193, Greenwood Village, CO80121

(Address of principal executive offices, Zip Code)

800-985-0515

(Registrant’s telephone number, including area code)

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

None
(Title of class)
Securities registered pursuant to Section 12(g) of the Act:
None
(Title of class)

Title of each classTrading Symbol(s)Name of each exchange on which registered
N/AN/AN/A

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ☑    No  ☐

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the precedingpast 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  ☐ No

Explanatory Note: The registrant is a voluntary filer and is therefore not subject to the filing requirements of the Securities Exchange Act of 1934; however, during the preceding 12 months, the registrant has filed all reports that it would have been required to file by Section 15(d) of the Securities Exchange Act of 1934 if the registrant was subject to the filing requirements of the Securities Exchange Act of 1934 during such time frame.

Indicate by check mark whether the registrant has submitted electronically, and posted on its corporate website, if any every interactive data fileInteractive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes No ☐

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☑

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

Large accelerated filerAccelerated Filer
Accelerated filerFiler
Non-accelerated filer  ☐ (Do not check if a smaller reporting company)Non-Accelerated FilerSmaller reporting company
Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

As

The aggregate market value of June 30, 2016,the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter, theJune 30, 2021, was approximately $11,185,976. The aggregate market value gives effect to the closing of the shares of commonSecurities Exchange Agreement dated June 30, 2021 and the 1-for-28 reverse stock held by non-affiliates of the registrant was not determinable.

Indicatesplit on October 28, 2021.

State the number of shares outstanding of each of the registrant’sissuer’s classes of common stock, as of the latest practicable date.  33,571,862date: 14,762,342 shares of Common Stockcommon stock, par value $0.0001 per share, outstanding as of March 28, 2017

DOCUMENTS INCORPORATED BY REFERENCE: None

15, 2023.

 
TABLE OF CONTENTS

Page Number
Part I
   

TABLE OF CONTENTS

1
Item 1.
Business1
Item 1A. 74
 1714
 1714
 1715
 1715
PART II16
Part II
 1816
 1816
 1816
 2220
 22F-1
 2321
 2321
 2422
PART III
Part III
 2522
 2623
 3024
 3125
 3225
PART IV26
Part IV
 3326
SIGNATURES27

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Cautionary Statement Regarding Forward-Looking Statements

This Annual Report on Form 10-K and other written and oral statements made from time to time by us may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about our new operations in the hemp industry through Panacea, our expected revenue growth, our future plans and developments, proposed federal legislation and its potential impact on the CBD industry, our plans to raise capital, and our liquidity. Words such as “expects,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” “may,” “intends,” “targets” and similar expressions or variations of such words are intended to identify forward-looking statements but are not the exclusive means of identifying forward-looking statements in this Report. The identification of certain statements as “forward-looking” is not intended to mean that other statements not specifically identified are not forward-looking. All statements other than statements about historical facts are statements that could be deemed forward-looking statements, including, but not limited to, statements that relate to our future revenue, product development, customer demand, market acceptance, growth rate, competitiveness, gross margins, and expenditures.

Although forward-looking statements in this Report reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties discussed under the heading “Risk Factors” within Part I, Item 1A of this Report, and other documents we file from time-to-time with the Securities and Exchange Commission (“SEC”). Such risks, uncertainties and changes in condition, significance, value, and effect could cause our actual results to differ materially from those expressed herein and in ways not readily foreseeable. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Report and are based on information currently and reasonably known to us. We undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date of this Report, other than as required by law. Readers are urged to carefully review and consider the various disclosures made in this Report, which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.

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PART I

Item 1. Business

General

Panacea Life Sciences Holdings, Inc. (PLSH) is holding company structured to support the life sciences and health and wellness industry. Its subsidiary, Panacea Life Sciences, Inc. (PLS) is dedicated to manufacturing, research and producing the highest-quality, hemp-derived cannabinoid, functional mushroom, Kratom and nutraceutical products for consumers and pets. Established in 2017, PLS is a woman-owned and woman-led company. Panacea operates out of its 51,000 square foot, state-of-the-art, cGMP facility in Golden Colorado, focusing on natural plant-based extraction, manufacturing, research, testing and fulfillment services. Panacea operates in every segment of the manufacturing value chain. From cultivation to finished goods, the company ensures its products with stringent GMP standards and testing protocols employed at every stage of the supply chain. Panacea also offers the purest natural remedies within its branded product lines for every aspect of life: PANA Health™, PANA Beauty®, PANA Sport™, PANA Pet®, PANA Pure® and PANA Life™. If you would like more information, please visit www.panacealife.com.

Recent Developments

In June 2022, given the FDA’s lack of clarity regarding the CBD industry, the Company pivoted some of its resources to focus on the nutraceutical industry. The Company made further investments in its softgel line for bovine and vegan softgels. The sales approach has been successful and we have closed over ten different nutraceutical contracts. In this same timeframe we have focused on two other natural plant products—functional mushrooms and kratom. These new areas will continue to be a focus area for Panacea in 2023.

On November 18, 2021, the Company and an institutional investor signed an agreement for a $1.1 million original issue discount convertible note (the “Note”) financing in which the investor is paying $1 million in gross proceeds. The one-year Note is convertible into common stock at $1.40 per share. We also issued the investor 785,715 warrants to purchase common stock at an exercise price of $1.40 per share. The warrants are exercisable over a five-year period beginning May 18, 2022. The loan payoff was made on December 15, 2022 for the amount of $1,115,000.

Our Competitive Analysis

We believe that our competitive advantages are derived from being vertically integrated that allows for extraction, enrichment and manufacturing under a cGMP quality environment: 1) Using pharmaceutical formulation methods to optimize the delivery of various nutraceutical, hemp, mushroom and kratom products, 2) Developing both full spectrum and THC-free products, 3) hemp supply, and 4) utilize Good Manufacturing Practice to produce goods that ensures safe and quality products that deliver consistent dosing. The ability to produce both full spectrum products (those that contain <0.3%) and THC-free products allows us to optimize dosage and delivery to various human conditions.

Industrial hemp extracts are found to have particular application as neuroprotectants, for example in limiting neurological damage and increasing speed of recovery with traumatic brain injury. The cannabinoids have also been reported to treat human disease conditions where currently multiple pharmacological products are needed, e.g., Post Traumatic Stress Disorder (PTSD), or where there is no current cure such as Alzheimer’s, Parkinson’s Disease, and age-related dementia, to name a few. Cannabinoids have a wide range of possible benefits which we are pursuing through clinical trials and studies.

Anti-Nausea /Antiemetic
Anticonvulsant
Antipsychotic
Anti-inflammatory
Anti-oxidant
Anti-tumoral / Anti-cancer
Anxiolytic / Anti-depressant
Reduces nausea and vomiting
Suppresses seizure activity
Combats psychosis disorders
Combats inflammatory disorders
Combats neurodegenerative disorders
Combats tumor and cancer cells
Combats anxiety and depression

Although numerous reports describe cannabis/hemp extract health benefits the industry lacks sufficient clinical data and quality control to provide patient benefit. We are combining human and pet clinical studies with Good Manufacturing Process manufacturing to generate a panel of products tailored and optimized for specific disease treatment. Our products are designed to optimize formulation with delivery method to maximize health benefits including an intellectual property portfolio enabling development of topical creams, sublingual products, oral soft gel capsules, patches, and sprays. Our products are derived from organic practices industrial hemp grown in Colorado.

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Our goals are to research, produce, and distribute products both domestically and internationally that target and treat major categories of medical conditions: pain, cancer, psychological, gastrointestinal, autoimmune, neurological, and sleep disorders. These categories include conditions that affect hundreds of millions of patients and animals worldwide.

Our goal is to be a leader in contract manufacturing for end-products, such as nutraceuticals, supplements and pet and farm products.

Our Intellectual Property

We operate in every segment of the cannabinoid product value chain. From the hemp plant to finished goods, we ensure our products with stringent testing protocols employed at every stage of the supply chain. Panacea endeavors to offer pure natural remedies within product lines for every aspect of life, Our portfolio includes the following trademarks and registrations: PANA Health™, PANA Beauty®, PANA Sport™, PANA Pet®, PANA Life®.

Research and Development

In October 2021, Panacea Life Sciences’ investment in the Cannabinoid Lab at Colorado State University (“CSU”) was realized. The Cannabinoid Research Center is conducting numerous studies and clinical research that will extend our knowledge of how cannabis extracts affect human and animal health. We will work through the center to form multiple research collaborations as well as perform our own studies in multiple therapeutic areas. The Panacea Life Sciences Cannabinoid Research Center is housed in the Chemistry Building in the heart of the CSU campus. The center is expected to be a leader in cannabinoid research nation and world-wide as the industry continues to grow.

Our Sales Strategy

As previously described, since our cannabinoid products contain little to no THC, we have the ability to sell our products across the United States and internationally. We have established a multi-faceted sales strategy targeting:

global ecommerce platform for fulfilling orders and shipping worldwide where legally permitted;
direct pharmacy placement;
direct placement in retail stores, salons, spas, athletic facilities, etc.
Intelligent vending machines
E-commerce based systems and social media

In addition, we have established several other sales channels via sales reps, e-commerce (selling directly to customers), large bulk sales to suppliers and to dispensaries. The e-commerce sales platform also works with the commissioned based sales. All sales commissions are tracked and paid via the ERP platform.

We also manufacture nutraceutical and other cannabinoid/kratom/mushroom products for several other companies for various white label and contract manufacturing deals. We specialize in bovine and vegan soft gel manufacturing.

Marketing and Distribution

We distribute our products to various businesses across the United States through channels optimized to the individual needs of customers. Our B2B as well as B2C approach allows much flexibility for healthcare providers the ability to recommend specific treatment options using cannabinoids as a replacement for conventional pharmaceuticals.

Currently we sell over 60 different product SKUs of CBD and CBG products. In addition, we offer “white label” licensing to retail businesses and contract manufacturing services to smaller CBD companies. We plan to continue to build an integrated healthcare organization by creating products and programs using emerging botanical extracts. We deliver these programs through managed agriculture, pharmaceutical production, physician education, distribution and social media networks. We use our intellectual property in extraction technology, proprietary compounds, delivery systems, and distribution to produce high-quality products in terms of control, consistency, accountability, and packaging.

All our products are stored in a secure distribution area in preparation for delivery to various sales channels, healthcare providers and other retail locations. The laboratory and production facility have the capacity for domestic and international delivery fulfillment and for international export. All products are tracked and securely manifested for delivery to retail and medical offices for distribution.

We are recruiting key service providers to leverage the power of online sales and social media placement. We have placed products on various online retail sales stores and has launched product sales on Amazon.com. As product ambassadors are secured, we intend to increase its online and social media exposure to advance a business-to-consumer and business to business distribution model.

In 2018, we entered into an agreement with Quintel-MC, Inc. to research and define Panacea Life Sciences business and manufacturing processes. The ERPCannabis system based on an SAP architecture was used to develop the base installation. All financial, human resource, payroll, procurement, production planning and materials management business processes are represented in this system. In addition, the system is linked to our e-Commerce web site. This system allows us to update product costing and determine inventory levels which will be critical as the company expands. In addition, sophisticated financial and payroll processing are inherent in the solution; thus, offering investors detailed accounting results related to company investments.

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Item 1.                      Business.
Company Overview
Exactus, Inc. (“Exactus”

Our Industrial Hemp Supply

Our 2020 and 2021 hemp crop was grown in NeedleRock Farms in Crawford CO. In 2021 XXII was the grower and is using organic practices for the crop. XXII is contractually obligated to provide use with $500,000 of hemp from the 2021 crop. We also have several hemp tolling contracts in which the output of crude and or distillate is shared with the growers.

Biotechnology Goals

We seek to take advantage of an emerging worldwide trend to utilize the production of cannabinoids derived from industrial hemp, such as CBD, CBDA, CBG, CBDV and CBN, to produce consumer products. Hemp is being used in cosmetics, nutritional supplements, and animal feed, where we also intend to focus our efforts. The market for hemp-derived products is expected to increase substantially over the next five years.

The therapeutic potential of cannabinoids is attributable to the valuable overlap between phyto-cannabinoids (i.e., “our”plant-derived cannabinoids) and the endogenous cannabinoid system in humans, termed a “therapeutic handshake”. Clinical trials demonstrate few adverse effects from oral CBD doses of up to 1,500 mg/day. The scientific understanding of the hemp plant’s clinical effects is based mostly on studies in specific indications, like epilepsy. One company, GW Pharmaceuticals pls, a leading company developing pharmaceutical drugs and cannabinoid-based medicines, has sought and obtained US and foreign approvals since 2018. EPIDIOLEX®/EPIDYOLEX® (cannabidiol), “us”the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. and the European Commission (EC) for use in Europe, is an oral solution which contains highly purified cannabidiol (CBD). In the U.S., “we”EPIDIOLEX® is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or Tuberous Sclerosis Complex (TSC) in patients one year of age and older.

Environmental Matters

Compliance with federal, state and local requirements regulating the discharge of materials into the environment, or otherwise relating to the protection of the environment, have not had, nor are they expected to have, any direct material effect on our capital expenditures, earnings or competitive position, however such factors could indirectly affect us as well as participants in the supply chain for our products, and our business, operations, vendors or suppliers.

Government Regulations

On December 20, 2018, the President of the United States signed the Farm Bill into law. Among other things, this new law changed certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and hemp products containing less than 0.3 percent delta-9-tetrahydrocannabinol (THC, including removing hemp and derivatives of hemp from the Controlled Substance Act. January 15, 2021, the USDA issued its final rule regarding the Establishment of a Domestic Hemp Production Program which authorized hemp to be grown and processed legally in the United States and made it legal to transport in interstate commerce.

The Farm Bill recognizes hemp as distinct from its genetic cousin, marijuana, and specifically industrial hemp has been excluded from U.S. drug laws. The Farm Bill allows for each individual state to regulate industrial hemp and industrial hemp-based products or accept the USDA rules. Although no longer a controlled substance under federal law, cannabinoids derived from industrial hemp (other than THC) are still subject to a patchwork of state regulations. We are actively monitoring the regulations and proposed regulations in each state to ensure our operations are compliant.

As of the date of this report, and based upon publicly available information, to our knowledge the FDA has not taken any enforcement actions against CBD companies. The FDA, however, has sent warning letters to companies demanding they cease and desist from the production, distribution, or advertising of CBD products, only relating to instances that such CBD companies have made misleading and unapproved label claims. We will continue to monitor the FDA’s position on CBD as the FDA has now transferred this area to Congress.

We are subject to federal and state consumer protection laws, including laws protecting the privacy of customer non-public information and the handling of customer complaints and regulations prohibiting unfair and deceptive trade practices. The growth and demand for online commerce has and may continue to result in more stringent consumer protection laws that impose additional compliance burdens on online companies. These laws may cover issues such as user privacy, spyware and the tracking of consumer activities, marketing e-mails and communications, other advertising and promotional practices, money transfers, pricing, product safety, content and quality of products and services, taxation, electronic contracts and other communications and information security.

There is also great uncertainty over whether or how existing laws governing issues such as sales and other taxes, auctions, libel, and personal privacy apply to the internet and commercial online services. These issues may take years to resolve. For example, tax authorities in several states, as well as a Congressional advisory commission, are currently reviewing the appropriate tax treatment of companies engaged in online commerce, and new state tax regulations may subject us to additional state sales and income taxes. New legislation or regulation, the application of laws and regulations from jurisdictions whose laws do not currently apply to our business or the “Company” referapplication of existing laws and regulations to Exactus, Inc.the internet and its wholly-owned subsidiary, unlesscommercial online services could result in significant additional taxes or regulatory restrictions on our business. These taxes or restrictions could have an adverse effect on our cash flows, results of operations and overall financial condition. Furthermore, there is a possibility that we may be subject to significant fines or other payments for any past failures to comply with these requirements.

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Human Capital

On December 31, 2022, we had 19 full-time employees. There are no collective bargaining agreements covering any of our employees. We believe that our success depends on our ability to attract, develop and retain key personnel. We believe that the context otherwise requires) was incorporated on January 18, 2008 as “Solid Solar Energy, Inc.”skills, experience and industry knowledge of our key employees significantly benefit our operations and performance.

Employee health and safety in the Stateworkplace is one of Nevada as a for-profit Company. On May 16, 2013, we filed a certificateour core values. The COVID-19 pandemic has underscored for us the importance of amendmentkeeping our employees safe and healthy. In response to the Company’s amendedpandemic, we have taken actions aligned with the World Health Organization and restated articlesthe Centers for Disease Control and Prevention in an effort to protect our workforce so they can more safely and effectively perform their work.

Employee levels are managed to align with the pace of incorporationbusiness and management believes it has sufficient human capital to changeoperate its business successfully.

Additional information

We file annual, quarterly and other reports, proxy statements and other information with the SEC. The SEC maintains a website at www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers such as our namecompany that file electronically with the SEC.

Our corporate website address is www.panacealife.com. We make available free of charge, through the Investor section of our website, annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K and amendments to “Spiral Energy Tech., Inc.” from Solid Solar Energy, Inc.  On February 29, 2016, we acquired allthose reports filed or furnished pursuant to Section 13(a) or 15(d) of the issued and outstanding capital stock of Exactus BioSolutions, Inc. (“Exactus BioSolutions”) pursuant to a Share Exchange Agreement, dated February 29, 2016,Act as soon as reasonably practicable after we electronically file such material with, Exactus BioSolutions (the “Share Exchange”). The Company issued 30 million shares of newly-designated Series B-1 Preferred Stockor furnish it to, the shareholdersSEC. The information which appears on our corporate website is not part of Exactus BioSolutionsthis report.

Item 1A. Risk Factors

RISK FACTORS

Investing in our common stock involves a high degree of risk. Investors should carefully consider the following Risk Factors before deciding whether to invest in us. Additional risks and uncertainties not presently known to us, or that we currently deem immaterial, may also impair our business operations or our financial condition. If any of the events discussed in the Share Exchange, representing approximately 87%Risk Factors below occur, our business, financial condition, results of voting controloperations or prospects could be materially and adversely affected. In such case, the value and marketability of our common stock could decline.

Summary Risk Factors

Our business is subject to numerous risks and uncertainties that you should consider before investing in our common stock. Set forth below is a summary of the Companyprincipal risks we face:

We intend to raise capital through the sale of our common stock or securities convertible or exercisable into our common stock soon which will have a dilutive effect on our existing stockholders;
Our ability to continue as a going concern is in doubt unless we obtain adequate new debt or equity financing and achieve sufficient sales levels;
Because we require additional capital to execute our business plan and expand our operations, our inability to generate and obtain such capital on acceptable terms, or at all, could harm our business, operating results, financial condition and prospects;
We are highly dependent on our Chief Executive Officer, and the loss of her services or a conflict of interest arising from her loans to us, and her other business endeavors would adversely affect us;
Our business and the CBD industry generally are subject to substantial regulation and governmental scrutiny characterized by high compliance costs and uncertainty, including the possibility that laws change in a manner adverse to us;
Panacea’s operations and our new Chief Executive Officer were not previously subject to SEC reporting obligations, which could render us difficult to evaluate and expose us to risk;
If we are unable to keep up with rapid technological change, consumer preferences and economic developments in our industry or in general, our products may become obsolete.
We could become subject to data privacy and security claims or enforcement actions, particularly due to our digital marketing efforts;
We may become subject to product liability or related claims based on our production and sale of products containing chemical compounds designed to be ingested or applied topically;

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Our Chief Executive Officer, directly and through entities she controls, owns a majority of our outstanding common stock and voting power on an as-converted basis, rendering other stockholders’ ability to influence matters before them limited in most cases; and
Operational risks such as material weaknesses and other deficiencies in internal control over financial reporting could result in errors, potentially requiring restatements of our historical financial data, leading investors to lose confidence in our reported results.

Risks Related to Our Business and the CBD Industry

Because we need to raise additional capital any financing based on our common stock or common stock equivalents will dilute our existing stockholders and the terms of any such financing could impose restrictions on our operations.

We have depended upon consummationloans from our Chief Executive Officer and principal stockholder and have primarily financed our operations by borrowing funds from her.

Because, we are highly dependent on the services of Leslie Buttorff, our sole executive officer, the loss of her and our inability to expand our management team, could harm our business.

Our success is largely dependent on the continued services of Leslie Buttorff, our Chief Executive Officer and principal stockholder. The loss of the Share Exchange. Asservices of Ms. Buttorff would leave us without executive leadership, which could diminish our business and growth opportunities. Additionally, Ms. Buttorff has business interests outside our company and a real estate holding company each of which hold shares in us as a result of the Sharerecent share exchange under the Exchange Exactus BioSolutions becameAgreement. Accordingly, from time-to-time she may not devote her full time and attention to our affairs, which could have a wholly-owned subsidiarymaterial adverse effect on our operating results, and there can be no assurance that a conflict of Exactus, Inc. Effective March 22, 2016,interest will not arise from her other business ventures. Further, as of December 31, 2022, Ms. Buttorff holds demand promissory notes totaling $14,796,011 at various interest rates ranging from 0% to 12%. Thus, she has the power to call the notes and obtain all our assets. Additionally, we changedhave a line of credit with Ms. Buttorff through which it may borrow up to $5 million at a 10% annual interest rate. The fact that she continues to advance money and is our corporate nameprincipal stockholder reflects her intent to “Exactus, Inc.” viasupport us.

The loss of Ms. Buttorff would have a mergermaterial adverse effect on us. We do not have key man insurance on the life of Ms. Buttorff. Ms. Buttorff’s Employment Agreement with us (the “Employment Agreement”) permits her to resign for good reason which includes our wholly-owned subsidiary, Exactus Acquisition Corp.

Following the Share Exchange, we became a life science company based in Glen Allen, Virginia that plans to develop and commercialize Point-of-Care (POC) diagnostics for measuring proteolytic enzymes in the blood based on a novel detection platform developed by Dr. Krassen Dimitrov, PhD. Our products will employ a disposable assay test strip combined with a portable and easy to use hand held detection unit that provides a result in as little as 30 seconds.
The first product will be used to assay fibrinolysis, which is the process by which clots in the blood are dissolved. The rate of fibrinolysis is carefully regulated in circulation; too little fibrinolysis leads to the formation of clots (thrombosis) and too much fibrinolysis prevents normal coagulation and can lead to excessive bleeding (hemorrhage). An elevated level of fibrinolysis is associated with many pathological conditions including myocardial infarction, pulmonary embolisms/deep vein thrombosis (PE/DVT) and ischemic stroke. Further, complications associated with surgical procedures and trauma can induce a hyperfibrinolytic state, leading to hemorrhage. In all of these medical situations, time ismaterial breach of the essence, and we believe current diagnostic technologies cannot return an actionableEmployment Agreement including our failure to pay her. In the event Ms. Buttorff terminates her Employment Agreement for good reason, this would result in the time frame necessary to provide timely therapeutic intervention.
The FibriLyzer is expected to provide a simple, rapidus owing her approximately $760,000 in severance pay plus any deferred compensation and affordable means to assess the fibrinolytic state of a patient in a broad range of applications including (i) the management of hyperfibrinolytic states associated with surgeryearned bonuses and trauma, (ii) obstetrics, (iii) diagnosis of acute events such as myocardial infarctionother benefits and ischemic stroke, (iv) diagnosis of pulmonary embolism and deep vein thrombosis, (v) chronic coronary disease management, and (vi) as a monitoring device to evaluate the effectiveness of coagulation therapy. We anticipate that the use of FibriLyzer will provide the basis for improving management of patients who are at-risk of hemorrhage, expediting treatment, potentially improving patient outcomes, and saving money.
We plan to follow up FibriLyzer with a similar technology to detect collagenase levels in the blood. This product, MatriLyzer, is intended to be used to detect the recurrence (or initial occurrence in high risk patients) of cancer and can be used aswould leave us without an at-home monitoring device or during routine office visits. The appearance of elevated levels of collagenase, the enzyme that degrades collagen, have been proven to be an early biomarker of recurrent cancer. For patients that have been previously treated for cancer, specifically, solid tumors, if and when the tumor recurs is of paramount importance. Once a tumor has begun to grow and spread, we believe that MatriLyzer can be used to detect this event at an early stage. If desired, our device will be designed to communicate directly with the attending oncologist via a smart phone application to ensure that the tests are being used properly and, when collagenase levels are elevated, both patient and physician will know the patient shouldexecutive officer which may have a more thorough examination.
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Unmet Medical Need
The formation of a blood clotmaterial adverse effect upon us, your investment, and its successive dissolution, known as the hemostatic balance, is required to arrest blood loss from an injured vessel; however, disruption of this balance leads to hemostatic disorders with either excessive bleeding (hemorrhage) or excessive clotting (thrombosis). During and after surgery or trauma, it is critical to monitor the hemostatic status of a patient because excessive bleeding (inadequate coagulation) is a common problem; however, proper peri- and post-operative patient management requires constant monitoring of hemostasis/fibrinolysis and current technologies are either too slow or too cumbersome to use efficiently, resulting in delayed, wasted or misapplied treatments and potentially poor patient outcomes.
The Euglobulin Lysis Test (ELT) test is the only regulatory-cleared test for measuring fibrinolysis; however, it requires several hours to conduct and is therefore impractical for use in diagnosing hyperfibrinolysis when treating trauma cases or surgery where treatment decisions have to be made within a few minutes of symptoms. D-dimer is another routine test for assessing fibrinolytic activity. The D-dimer is a proteolytic breakdown product of fibrin that is easily measured by latex agglutination assay and is considered to be a surrogate biomarker for fibrinolysis; however, while the D-dimer test is used broadly, the test still requires at least 20 minutes to return a result and the test has a very low specificity rate (high false positives) making the utility of the test less than optimal for identifying patients with hyperfibrinolysis. The D-dimer test is not cleared by the Food and Drug Administration (“FDA”), but is provided in clinical chemistry labs and a Laboratory Developed Test (LDT).
Physicians recognize the inadequacy of ELT and other Conventional Coagulation Tests (CCTs) such as Prothrombin Time, Partial Thromboplastin Time, Fibrinogen Levels and D-dimer, so they have turned to viscoelastometric methods to gather information on the coagulation process (da Luz et al 2013, Ramos et al 2013, Yeung et al 2014). Viscoelastometric methods require a bulky apparatus (ROTEM/TEG) and at least 10-30 minutes per test to return graphical output from which parameters can then be derived to indicate levels of fibrinolytic activity. However, patients’ hemostatic conditions can change significantly in just a few minutes. These methods are unable to provide rapid diagnosis of fibrinolytic status in the OR and ER, and viscoelastometric methods lack thehamper our ability to provide true real-time feedbackcontinue operations. If we fail to physiciansprocure the services of additional executive management or implement and execute an effective contingency or succession plan for optimal, case-specific administrationMs. Buttorff, the loss of critical treatments to counteract hyperfibrinolysis during surgery or trauma management. Further, viscoelastometric tests provide information on only severe forms of hyperfibrinolysis and lack the sensitivity to diagnosis the onset of hyperfibrinolysis (Franz 2009, Schöchl et al 2012). The use of viscoelastometric devices is complicated further by the (i) requirement for multiple daily calibrations, (ii) the requirement for highly trained technicians to conduct the assay, and (iii) the lack of standardization of viscoelastometric protocols (da Luz et al 2013). As a result, there have been calls for a faster and easier-to-use tool for providing feedback on this important physiological process.
Product Candidates
FibriLyzer
FibriLyzer is a device based on new technologies that are patented or pending patent and designed to address the shortcomings of the viscoelastometric devices, clinical tests such as D-dimer as well as ELT. FibriLyzer has two components. First, a portable, hand held analyzer about the size of blood glucose meters, measures the fibrinolytic activity in a drop of blood and returns a result in as little as 30 seconds. This unit is equipped with a bar-code scanner to record patient information. The unit can be connected via a USB port to ensure that the results of each test become part of the patient’s electronic record and are communicated to the appropriate hospital staff. Second, a disposable assay test strip or “biosensor” contains a synthetic protein matrix that simulates a clot. A proprietary electrochemically active polymer (“elactomer”) is embedded into the matrix and is released as the synthetic “clot” is dissolved, which generates electrical current in direct proportion to the amount of fibrinolysis.
In practice, a disposable assay test strip is inserted into the FibriLyzer device and a drop of blood is placed into an opening end of the strip. The blood sample is drawn into the strip by capillary action and the fibrinolysis assay begins immediately as the device measures the current across the test-end of the biosensor, which contains the synthetic fibrin matrix. At a specific time point (20 seconds), the end-point current is recorded and the results are displayed on an easy to read screen on the hand held unit. Based on a pre-defined threshold, the operator can immediately determine the fibrolytic state of the patient to inform patient management decisions in real time. Once the test is completed, the assay test strip is removed and discarded.
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In May 2013, a clinical beta test was performed as an initial assessment of a prototype device in a clinical setting. The trial included 30 healthy volunteers and 62 patients from the cardiology ward at University Hospital “Queen Yoanna” in Sofia, Bulgaria and was managed by Prof. Assen Goudev, Departmental Chair of Cardiovascular Medicine.
The three goals of this beta test were accomplished: (i) medical personnel easily managed the administration of FibriLyzer; (ii) samples from the healthy volunteers produced fibrinolysis readings that demonstrated a groupingMs. Buttorff would significantly disrupt our business from which a “normal range” could be derived; and (iii) after only 20 seconds, the samples taken from the cardiac patients yielded a scattered distribution that was very different than the comparatively tight distribution for the healthy sample, demonstrating the cardiovascular patients’ varying degrees of elevated fibrinolysis.
This beta test showed that the technology performed as expected in a clinical setting and confirmed that it should move into formal clinical trials designed to garner marketing approval. We anticipate submitting a premarket notification to the FDA for FibriLyzer as Class II device pursuant to Section 510(k) of the FDAC.
In the European Union (the “EU”), we will seek to register FibriLyzer under Annex II List B of the European Directive 98/79/EC, which requires that the Company declare and ensure that FibriLyzer meets the requirements described in this annex.
It is anticipated that the clinical studies will include sites in both the U.S. and the EU and the protocol will be designed such that both the FDA as well as the EU’s IVD CE Mark requirements are met. We plan to use sufficient sites in the U.S. and EU to expedite the time needed to complete our clinical development. We will work closely with the FDA to ensure that our clinical development and analytical plans are sufficiently robust to satisfy the regulatory requirements and plan to seek marketing clearance with EU authorities concurrently with the Food, Drug, And Cosmetic Act (the “FDAC”) in mid-2018 and anticipate that we will be eligible to market and sell products by the end of 2018.
MatriLyzer
Using technology similar to FibriLyzer, the Company intends to develop a diagnostic device to detect the recurrence of cancer. Each year, more than 700,000 people undergo cancer surgery in the United States. However, more than 40% of those patients develop recurrent disease and many have correspondingly poor outcomes. There remains an unmet need to diagnose cancer recurrence at its earliest stages in order to treat the patient swiftly.
Well-characterized proteases have been long recognized as major contributors to the proteolytic degradation of extracellular matrix during tumor invasion. In the recent years, other non-matrix proteins have also been identified as elatinase substrates thus significantly broadening our understanding of these enzymes as proteolytic executors and regulators in tumor progression. As with fibrinolysis, MatriLyzer will detect the increase in collagenase activity in the blood using the same elactomer technology used in FibriLyzer. In MatriLyzer, the biosensor will contain a collagen-based matrix, but the principle of detection will remain the same. Our approach will be to validate the correlation of increased collagenase levels with cancer recurrence and then market the test for routine office use or at-home use.
Global Medical Diagnostics Device Market
The In Vitro diagnostics device industry is currently one of the most dynamic and innovative economic sectors today, driven by rapid advances in micro-technology and biomedical research. These advances have combined to enable the collection of biometric data of scope and accuracy much greater than just ten or fifteen years ago. The sector can be divided into various horizontal segments such as cardiovascular, oncology, hematology, and neurology. Diagnostic devices may be utilized independently to assess specific biomarkers; or they may act as “companion” devices, working in conjunction with therapeutics or other treatments to improve patient outcomes. Currently bringing in over $50 billion in revenue, the industry is expected to continue to expand as new technologies are introduced that directly address previously unmet needs of patients and clinicians.
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Globally, the U.S. market is the largest, providing for roughly one third of all revenues. The regulatory pathway has been criticized for being overly cumbersome; however, recent efforts to streamline and clarify the processes have improved outcomes in the approval process. A recent survey (Parmar, 3.26.14) revealed that despite greater cost concerns, most hospital CEOs are open to new technologies if they can improve the quality of patient care, lower hospitals’ overall costs, or increase the efficiency of their clinical staffs. Despite increased scrutiny, the U.S. market for diagnostic devices is expected to show continued growth due to an increasing ability of researchers to address unmet needs, greater participation in preventive care, and the need to monitor and manage “lifestyle” diseases (cardiovascular, diabetes, etc.) of the growing elderly population.
The European market is currently the second largest and is generally viewed as being more accommodating to new devices and technologies. As in the U.S., serving unmet needs and managing lifestyle diseases are engines of growth. Emerging markets are recognized as providing the opportunity for fastest growth as higher middle-class incomes and increasing awareness of the benefits of a healthcare system drive new demand through higher participation rates. Also, new government policies encourage the introduction of advanced technologies to rural regions.
The Company plans to initially market FibriLyzer for (i) the identification of hyperfibrinolytic states associate with surgery and trauma, (ii) obstetrics, (iii) acute events such as myocardial infarction and ischemic stroke, (iv) pulmonary embolism and deep vein thrombosis, and (v) chronic coronary disease management. Together these markets have more than 10 million cases annually.
The market for MatriLyzer is quite large with over 4 million patients treated for cancer each year in the U.S. and EU who could be monitored for recurrence of cancer by observing collagenase levels. In addition to newly treated patients, a pool of 20 million potentially recurrent cancer survivors would be eligible for collagenase monitoring as well. Both patients and survivors will potentially benefit from regular and frequent monitoring for recurrence.
Licensing Agreement
Our business substantially depends on our licensed technology. We have entered into an exclusive licensing agreement, the “Licensing Agreement” with Digital Diagnostics Inc. (“Digital Diagnostics”) to develop, produce and commercialize certain diagnostic products, including FibriLyzer and MatriLyzer, which utilize certain intellectual property rights owned or licensed by Digital Diagnostics. The Licensing Agreement provides for Exactus BioSolutions and Digital Diagnostics to collaborate through the various steps of the product and device development process, including the development, regulatory approval, commercialization and manufacture stages. Exactus BioSolutions is required to pay Digital Diagnostics, in cash and/or stock, an initial signing payment, milestone fees triggered by the first regulatory clearance or approval of each of FibriLyzer and MatriLyzer, and various sales thresholds, and royalty payments based on the net sales of the products, calculated on a product-by-product basis. The initial signing payment is due within seven days of the effective date of the agreement, with the remaining amount due upon closing of certain of our financing transactions. In 2016, we paid $50,000 to Digital Diagnostics as part of the initial signing payment under the Licensing Agreement and $21,659 in legal expenses. As of December 31, 2016, we accrued an additional $171,033 in licensing fees due to closing a financing transaction in the fourth quarter of 2016. No milestones have been met and no milestone fees have been paid or accrued for through December 31, 2016.
The License Agreement is effective on a product-by-product and country-by-country basis until such time as neither Digital Diagnostics nor Exactus Biosolutions has any obligation to the other under the License Agreement in such country with respect to such product. The License Agreement may be terminated by Exactus BioSolutions as a whole or on a country-by-country and/or product-by-product basis, effective upon at least six (6) months written notice if regulatory approval has been obtained in the U.S. or in the EU, or upon at least three (3) months written notice if regulatory approval has not been obtained in the U.S. or in the EU. Either party may terminate the License Agreement in the event the other party materially breaches the License Agreement, or becomes insolvent.
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Competition
We compete in the in vitro diagnostics device industry, subject to rapid changes in micro-technology and biomedical research, and significantly affected by new product introductions. We know of no other competitor developing hand-held Point-of-Care devices that detect fibrinolysis or collagenase. The FibriLyzer works by determining fibrinolytic activity by the rate at which a proprietary synthetic fibrin matrix is dissolved by enzymes in the blood. Competitors include companies that sell larger tabletop machines which may be used at the Point-of-Care for detection of various coagulation parameters through different methods, including thromboelastography (TEG) by Haemonetics Corporation, and rotation thromboelastometry (ROTEM) by Tem International.
Our product is unique because unlike TEG and ROTEM, it does not require a significant amount of blood, or technical expertise to operate. In addition, these products require 10-30 minutes to deliver any data. We believe that the absence of a hand-held Point-of-Care device for the detection of fibrinolysis or collagenase in real time creates a significant opportunity to penetrate the market.
Manufacturing, Distribution and Marketing
We are working with TaiDoc Technology Corporation (“TaiDoc”) in Taipei, Taiwan, a well-established medical device manufacturer with certifications from regulatory authorities worldwide, including the FDA, to manufacture the FibriLyzer and disposable assay test strips. TaiDoc and Digital Diagnostics have an existing contract manufacturer agreement pursuant to which TaiDoc will manufacture the FibriLyzer and Digital Diagnostics will be its exclusive distributor, and we currently are negotiating a formal agreement with TaiDoc to manufacture these products. As described in more detail under “—Government Regulation and Approval,” these third parties must comply with FDA and applicable foreign regulations regarding manufacturing our products. Failure to maintain compliance with such regulations could result in a sudden or unexpected interruption in our operations as we may not be able to quickly establish additionalrecover.

If we are unable to develop and maintain our brand and reputation for our product offerings, our business and prospects could be materially harmed.

Our business and prospects depend, in part, on developing and then maintaining and strengthening our brand and reputation in the markets we serve. If problems with our products cause our customers to have a negative experience or replacement manufacturers of our products.

We do not have dedicated sales, marketingfailure or distribution personnel yet, because nonedelay in the delivery of our products to our customers, our brand and reputation could be diminished. If we fail to develop, promote and maintain our brand and reputation successfully, our business and prospects could be materially harmed.

Because we face intense competition, we may not be able to increase our market share which would materially and adversely affect us.

Our industry is highly competitive. It is possible that future competitors could enter our market, thereby causing us to lose market share and revenues or fail to grow our operations and market presence as intended or at all. In addition, some of our current or future competitors have significantly greater financial, technical, marketing and other resources than we do or may have more experience or advantages in the markets in which we will compete that will allow them to offer lower prices or higher quality products. If we do not successfully compete with these competitors, we could fail to develop a sufficient market share to achieve our goals and our future business prospects could be materially adversely affected.

Because the sale of our products involves the potential for product liability, we may incur significant losses and expenses in excess of our insurance coverage.

We face an inherent risk of exposure to product liability claims if the use of our products results in, or is believed to have resulted in, illness or injury. Our products are designed for ingestible or topical use and contain combinations of ingredients, and there is little experience with or knowledge of the long-term effects of these combinations. In addition, interactions of these ingredients and products with other products, prescription medications and over-the-counter treatments have not been approvedfully explored or understood and may have unintended consequences. Future research or results may lead to the discovery of unknown adverse side effects from CBD, which would harm our business.

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Although we believe all our products will be safe when taken as directed by us, there is little long-term research on the effects of human consumption of certain of the new product ingredients or combinations in concentrated form that we use or may in the future use in developing our CBD products. Any instance of illness or negative side effects of ingesting CBD products or applying them topically on the skin could have a material adverse effect on our business and operations by, among other things, exposing us to the risk of costly litigation and/or governmental sanctions and dramatically reducing the demand for commercial sale. Ifsome or all our products.

Any product liability claims or related developments from our products or CBD in general may increase our costs and whenadversely affect our revenue, product demand and operating results. Moreover, liability claims arising from a serious adverse event may increase our costs through higher insurance premiums and deductibles and may make it more difficult to secure adequate insurance coverage in the future. In addition, our product liability insurance may fail to cover future product liability claims, which, if adversely determined, could subject us to substantial monetary damages.

The success of our business will depend upon our ability to create and expand our brand awareness.

The health and wellness and CBD markets we compete in are highly competitive, with many well-known brands leading the industry. Our competitors include CBD companies who have a longer history operating in these markets than we do. Our ability to compete effectively and generate revenue will be based upon our ability to create and expand awareness of our products distinct from those of our competitors. It is imperative that we are able to convey to consumers the benefits of our products both in general and as compared to competitive offerings. However, advertising, packaging and labeling of our products is limited by various regulations. Our success will be dependent upon our ability to convey to consumers that our products are approved for commercial sale, we intendsuperior to develop an in-house teamthose of our competitors while complying with complex and varying regulations in the United Statesmarkets in which we attempt to market and distributesell them.

If we fail to develop and introduce new products it will adversely affect our future prospects.

Our industry is subject to rapid change. New products are constantly introduced to the market. Our ability to remain competitive depends in part on our ability to enhance existing products, to develop and manufacture new products in a timely and cost-effective manner, to adequately anticipate, prepare and execute strategies for market transitions, and to effectively market our products. Management believes that our future financial results will depend to a great extent on the successful expansion of our current product offerings and on the development and introduction of new products. We expectcannot be certain that we will be successful in selecting, developing, manufacturing and marketing new products or in improving upon or enhancing the market for existing products.

The success of new product introductions or expansions to collaboratenew territories depends on various factors, including, without limitation, the following:

Successful sales and marketing efforts;
Timely delivery of the products;
Availability of raw materials and/or sufficient production facilities;
Pricing of raw materials and labor;
Regulatory allowance and restrictions of the products; and
Market acceptance and consumer sentiment.

If we fail to appropriately respond to changing consumer preferences and demand for new products, it could significantly harm our customer relationships and product sales and harm our operating results and financial condition.

Our business is subject to changing consumer trends and preferences, especially with respect to targeted nutrition and natural wellness products. Our success will depend in part on our ability to anticipate and respond to these changes, and we may not respond in a timely or commercially appropriate manner to such changes. Furthermore, the medical communityhealth and wellness industry is characterized by rapid and frequent changes in demand for products and new product introductions and enhancements. Our failure to utilize online marketingaccurately predict these trends could negatively impact consumer opinion of our products, which in turn could harm our customer relationships and product demands and cause the loss of sales. The success of our product offerings depends upon a number of factors, including our ability to:

Accurately anticipate consumer needs;
Successfully commercialize new products or product enhancements in a timely manner;
Price our products competitively;
Arrange for the production and delivery our products in sufficient volumes and in a timely manner;
Differentiate our products from those of our competitors; and
Innovate and develop new products or product enhancements that meet these trends.

If we do not meet these challenges, some of our products could be rendered obsolete, which could negatively impact our operating results and financial condition.

Adverse publicity associated with our products or ingredients, or those of our competitors or similar businesses, could adversely affect our sales and revenue.

Adverse publicity concerning any actual or purported failure by us or our competitors to showcasecomply with applicable laws and create awarenessregulations or concerning any other aspect of our business or the CBD industry could have an adverse effect on the public perception of us and our products. This, in turn, could negatively affect our ability to obtain financing, endorsers and attract distributors, retailers or consumers for our products, which would have a material adverse effect.

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Our distributors’ and customers’ perception of the safety, utility and quality of our products or even similar products distributed by others can be significantly influenced by national media attention, publicized scientific research or findings, product liability claims and other publicity concerning our products or similar products distributed by others. Adverse publicity, whether accurate or not, that causes a perceived connection between consumption of our products or any similar products and illness or other adverse effects, will likely diminish the public’s perception of and in turn the demand for our products. Claims that any products are ineffective, inappropriately labeled or have inaccurate instructions as to their use, could have a material adverse effect on the market demand for our products, including reducing our sales and revenue, which would have a material adverse effect on our business.

If we are unable to manufacture our products in sufficient quantities or at defined quality specifications or are unable to maintain regulatory approvals for our production facility, we may be unable to develop or meet demand for our products and lose time to market and potential revenues.

Commercialization of our products require access to, or development of, facilities to manufacture a sufficient supply of our products. Our initial marketing efforts will target physicians, hospital administrators, hospital service providers, and group purchasing organizations.

Government Regulation and Approval
United States Product Development, Review and Approval Process
The FDA regulates all medical devices commercially distributedIn the future we may face difficulties in the United States. Medical devices are defined by the FDAC and subject to the regulatory controls of the FDAC and other federal regulations. The FibriLyzer is considered a medical device pursuant to the FDAC, and is thereby subject to the FDAC’s pre-market requirements.
Prior to the commercial distribution of the FibriLyzer in the United States, a pre-market approval, pre-market clearance, or an exemption from the FDA must be secured. We are requesting clearance of the FibriLyzer as a Class II device pursuant to the FDAC 510(k) pre-market clearance process, which requires us to submit a 510(k) notification to the FDA demonstrating that the FibriLyzer is substantially equivalent to a device already on the market that does not require pre-market approval, known as a “predicate.” A device will be deemed to be substantially equivalent to a predicate if it has the same intended use and technological characteristics. Where a device’s technological characteristics are different from the predicate, the FDA may nonetheless conclude that it is substantially equivalent as long as it has the same intended use, and the information provided to the FDA does not raise new questions of safety or effectiveness and demonstrates that the device is as safe and effective as the predicate. A successful 510(k) approval results in an order from the FDA stating that the device is substantially equivalent to a predicate and that it can be marketed in the United States.
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United States Post-Approval Processes
We are in the process of pursuing the regulatory approvals required to sell our products in the United States. Any products for which we receive FDA approvals will be subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, complying with certain electronic records and signature requirements and complying with FDA promotion and advertising requirements. The FDA strictly regulates labeling, advertising, promotion and other types of information on products that are placed on the market. Products may be promoted only for the approved indications and in accordance with the provisions of the approved label. Furthermore, product manufacturers must continue to comply with good manufacturing practices requirements, which are extensive and require considerable time, resources and ongoing investment to ensure compliance. In addition, changes to the manufacturing process generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.
Manufacturers and other entities involved in the manufacturing and distribution of an approved biological or medical device product are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with good manufacturing practices and other laws. The good manufacturing practices requirements apply to all stages of the manufacturing process, including the production, processing, sterilization, packaging, labeling, storage and shipment of the product. Manufacturers must establish validated systems to ensure that products meet specifications and regulatory standards, and test each product batch or lot prior to its release.
Manufacturers of biological products must also report to the FDA any deviations from good manufacturing practice that may affect the safety, purity or potency of a distributed product; or any unexpected or unforeseeable event that may affect the safety, purity or potency of a distributed product. The regulations also require investigation and correction of any deviations from good manufacturing practice and impose documentation requirements.
We currently rely on third parties for the production of our products. Future FDA and state inspections may identify compliance issues at the facilities of contract manufacturers may disruptdevelopment, production or distribution of our products.

We may face competition for access to any third-party supply sources, development or may require substantial resources to correct.

The FDA may withdraw a product approval if compliance with regulatory standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market. Furthermore, the failure to maintain compliance with regulatory requirements may result in administrative or judicial actions,production partners and facilities such as fines, warning letters, holds on clinical studies, product recalls or seizures, product detention or refusal to permit the import or export of products, refusal to approve pending applications or supplements, restrictions on marketing or manufacturing, injunctions or civil or criminal penalties.
In addition, from time to time, new legislation is enacted that can significantly change the statutory provisions governing the approval, manufacturinghemp growers and marketing of products regulated by the FDA. In addition to new legislation, FDA regulations and policies are often revised or reinterpreted by the agency in ways that may significantly affect our business and our products. It is impossible to predict whether further legislative or FDA regulation or policy changes will be enacted or implemented and what the impact of such changes, if any, may be.
International Regulation
We may be subject to widely varying foreign regulations,production delays if any of those third parties give their other business partners a higher priority than they give to us. Even if we are able to identify additional or replacement third parties, the delays and costs associated with establishing and maintaining a relationship with such third parties may have a material adverse effect on us. Further, a reduction in the control of our production efforts would be inherent in any such outsourcing, which exposes us to a greater risk of liability, including regulatory enforcement actions for alleged noncompliance with law and product liability claims. This could also result in lower product quality which could negatively impact demand for our offerings or our competitive advantage. Any of these challenges could prevent us from achieving our business objectives and harm your investment in us.

If the market opportunities for our current and potential future products are less lucrative than anticipated, our ability to generate revenues may be quite different from thoseadversely affected and our business may suffer.

Our understanding, expectation and estimates of the FDA, governing clinical trials, manufacture, product registrationmarket for our current and approval,future products may prove to be incorrect, and sales. Whethernew test results or not FDA approval has been obtained, we must obtainstudies, reports, legislative or regulatory developments or other factors beyond our control may result in the market for our products being lower than anticipated on a separate approval for a product byregional, national or global scale. The number of individuals in the comparable regulatory authorities of foreign countries priorU.S. who are willing to the commencement of product marketing in these countries. In certain countries, regulatory authorities also establish pricing and reimbursement criteria. The approval process varies from country to country, and the timepurchase our products may be longerlower than expected, or shorterexpectations for repetitive purchases and consumption may prove to be incorrect. These occurrences could materially adversely affect our prospects and operational results.

If we are unable to establish relationships with third parties to carry out sales, marketing, and distribution functions or to create effective marketing, sales, and distribution capabilities, we will be unable to market our products successfully.

Our business strategy includes using third parties to market and sell the products at the retail level. There can be no assurance that we will successfully be able to establish marketing, sales, or distribution relationships with a sufficient number of third parties to meet our goals, that such relationships, if established, will be successful, or that we will be successful in gaining market acceptance for current or future products. To the extent that we enter into any marketing, sales, or distribution arrangements with third parties, our product revenues per unit sold are expected to be lower than

if we marketed, sold, and distributed our products directly, and any revenues we receive will depend upon the efforts of such third parties.

If we are unable to establish such third-party marketing and sales relationships, we would have to establish and grow in-house marketing and sales capabilities. To market any products directly, we would have to build a marketing, sales, and distribution force that requiredhas technical expertise and could support a distribution capability. Competition in the health and wellness and cannabinoid industries for FDA approval. Therefore, we cannot assuretechnically proficient marketing, sales, and distribution personnel is intense, and attracting and retaining such personnel may significantly increase our costs. There can be no assurance that we will be able to satisfyestablish internal marketing, sales, or distribution capabilities or that these capabilities will be sufficient to meet our needs.

Because of the regulatory requirementsRussian Invasion of Ukraine, the effect on the capital markets and the economy is uncertain, and as a result we may have to selldeal with a recessionary economy and economic uncertainty, including possible adverse effects upon our ability to raise capital as and when needed.

As a result of the Russian invasion of Ukraine, certain events are beginning to affect the global and U.S. economy including increased inflation, substantial increases in the prices of oil and gas, large Western companies ceasing to do business in Russia and uncertain capital markets with declines in leading market indexes. The duration of this war and its impact are at best uncertain. Ultimately the economy may turn into a recession with uncertain and potentially severe impacts upon public companies and us, including our ability to raise capital. We cannot predict how this will affect our operations or the industries in which we operate, however any such impact may be material and adverse.

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We have a limited operating history upon which investors can evaluate our future prospects.

Panacea was founded and began operations in the CBD industry in 2017 and we therefore have a limited operating history upon which an evaluation of our business plan or performance and prospects can be made. Our business and prospects must be considered in the light of the potential problems, delays, uncertainties and complications encountered in connection with a business which is still in its early stages in a relatively new industry characterized by unexpected change. The risks include, but are not limited to, the possibility that we fail to develop functional and scalable products, or that although functional and scalable, our products will not be economical to market in order to become or remain profitable; that our competitors hold proprietary rights precluding us from marketing such products; that our competitors offer a superior or equivalent product or otherwise achieve or maintain greater market acceptance than us; that we are unable to upgrade or improve our processes and products to accommodate new features and expand our offerings; or that we fail to receive or maintain necessary regulatory clearances and compliance for our products and operations. In order to grow our revenue, we must develop and improve upon our brand name recognition and competitive advantages for our products and expand into new markets. Even if we accomplish such growth, resulting expenses may be greater than estimated, which could reduce or even eliminate any foreign country.

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Employees
the 2018 Farm Bill described below, our industry experienced an influx of hemp farmers and producers which resulted in a saturated marketplace. As of December 31, 2016,a result, the supply for CBD and related products has in the past exceeded demand. This trend could force us to reduce our prices to remain competitive or could result in lower sales levels than we have 3 employees, allexperienced in the past, either of which would result in a decline in revenue or growth rate and could materially adversely affect our financial condition and prospects.

If we fail to attract new customers in a cost-effective manner, our business may be harmed.

A large part of our success depends on our ability to attract new customers in a cost-effective manner. We have made, and may continue to make, significant investments in attracting new customers through increased advertising spends on social media, radio, podcasts, and targeted email communications, other media and events, sponsorships, and influencer sponsorships. Marketing campaigns can be expensive and may not result in the cost-effective acquisition of customers. Further, as our brand becomes more widely known, future marketing campaigns may not attract new customers at the same rate as past campaigns and the cost of acquiring new customers may increase over time. Additionally, regulation, algorithms, or participants in the digital marketing ecosystem may change rules for our industry or access to available demographics which may result in significant changes in the ability to target key demographic pools, impacting our ability to target our customers effectively. If we are full time.

Item 1A.              Risk Factors
Risks Relatedunable to Our Companyattract new customers, or fail to do so in a cost-effective manner, our business may be harmed.

Even if we meet our growth objectives and Our Business

Ourour enter into new markets as intended, we may face difficulties evaluating our current and future business is at an early stage of developmentprospects, and we may not developbe unable to effectively manage any growth associated with these achievements, which would increase the risk of your investment losing value and could harm our business, financial condition, and results of operations.

Our entry into new markets and/or growth in our product offering or consumer base may place a significant strain on our resources and increase demands on our executive management, personnel and operational systems, and our human, administrative and financial resources may be inadequate to meet these demands. We may also be unable to effectively manage any expanded operations or achieve planned growth on a timely or profitable basis, particularly if the number of customers using our products thatsignificantly increases within a short period of time. If we are unable to manage expanded operations effectively, we may experience operating inefficiencies, the quality of our products could decline, and our business and results of operations could be materially adversely affected.

If we cannot manage our growth effectively, our results of operations would be materially and adversely affected.

We expect to experience growth as we raise additional capital. Businesses which grow rapidly often have difficulty managing their growth while maintaining their compliance and quality standards. If we grow as rapidly as anticipated, we will need to expand our management by recruiting and employing additional executive and key personnel capable of providing the necessary support. There can be commercialized.

In February 2016, we acquired Exactus BioSolutions and changed our primary business focus to developing, producing and commercializing blood diagnostic products, including FibriLyzer and MatriLyzer, utilizing certain intellectual property rights exclusively licensed by Exactus BioSolutions. Prior tono assurance that time, our primary business focus was developing and commercializing drone technology. As a result, our business is at an early stage of development. We are preparing to conduct clinical trials on our primary product, FibriLyzer, and we expect tomanagement, along with staff, will be able to marketeffectively manage our growth nor can there be any assurance that growth in our product offerings, customer base or contracts will translate to an increase in revenue or profitability. Any failure to meet the challenges associated with rapid growth could materially and selladversely affect our business and operating results.

Existing or future governmental regulations relating to cannabinoid products by the end of 2018. Ourmay harm or prevent our ability to generate revenues from sales will depend, among other things,produce and/or sell our successful completionproduct offerings.

While a majority of clinical trials, regulatory approvals, commercialization and market acceptance of our technologies and products, medical community awareness and changes in regulations.

Our products, including FibriLyzer, will require significant additional research and development, clinical testing and regulatory approvalstate governments in the United States Canadahave legalized the growing, production, and Europe,use of CBD in some form and subject to certain restrictions, cannabis remains illegal under federal law. In addition, in July 2017, the United States Drug Enforcement Agency issued a statement that certain CBD extractions fall within the definition of marijuana and are therefore a Schedule I controlled substance under the Controlled Substances Act of 1970, as amended. Thus, the cannabis industry, including companies which sell products containing CBD, faces significant uncertainty surrounding regulation by the federal government, which could claim supremacy over state regulatory regimes including those with a “friendlier” view toward CBD products. While the federal government has for several years chosen to not intervene in the cannabis business conducted legally within the states that have legislated such activities, there is, nonetheless, potential that the federal government may at any time choose to begin enforcing its laws against the manufacture, possession, or use of cannabis-based products such as CBD. Similarly, there is the possibility that the federal government may enact legislation or rules that authorize the manufacturing, possession or use of those products under specific guidelines. Local, state and federal cannabis laws and regulations are broad in scope and subject to evolving interpretations. In the event the federal government was to tighten its regulation of the industry, we would likely suffer a material adverse effect on our business, including potentially substantial losses.

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Because laws and regulations affecting our industry are evolving, changes to any regulation may materially affect our CBD products.

In conjunction with the enactment of the Agriculture Improvement Act of 2018 (the “Farm Bill”), the Food and Drug Administration (the “FDA”) released a statement about the status of CBD as a nutritional supplement, and the agency’s actions in the short term with regards to CBD will guide the industry. As a company whose products contain CBD, we intend to meet all FDA guidelines as the regulations evolve. Any difficulties in compliance with future government regulation could increase our operating costs and adversely impact our results of operations in future periods.

In addition, as a result of the Farm Bill’s passage, we expect that there will be a constant evolution of laws and regulations affecting the CBD industry which could affect our operations. Local, state and federal hemp laws and regulations may be broad in scope and subject to changing interpretations. These changes may require us to incur substantial costs associated with legal and compliance fees and ultimately require us to alter our business plan. Furthermore, violations of these laws, or alleged violations, could disrupt our business and result in a material adverse effect on our operations. In addition, we cannot predict the nature of any future laws, regulations, interpretations or applications, and it is possible that regulations may be enacted in the future that will be directly applicable to our business.

Unexpected changes in federal and state law could cause any of our current products, as well as products that we intend to develop and launch, containing hemp-derived CBD oil to be illegal, or could otherwise prohibit, limit or restrict any of our products containing CBD.

Our business is based on the production and distribution of products containing hemp-derived CBD. The Farm Bill, which amended various sections of the U.S. Code, and legalized the cultivation and sale of industrial hemp at the federal level, subject to compliance with certain federal requirements and state law. There can be no assurance that the Farm Bill will not be repealed or amended such that our products containing hemp-derived CBD would once again be deemed illegal under federal law.

The Farm Bill delegates the authority to the states to regulate and limit the production of hemp and hemp-derived products within their territories. Although many states have adopted laws and regulations that allow for the production and sale of hemp and hemp-derived products under certain circumstances, no assurance can be given that such state laws may not be repealed or amended such that our intended products containing hemp-derived CBD would once again be deemed illegal under the laws of one or more states now permitting such products, which in turn would render such intended products illegal in those states under federal law even if the federal law is unchanged. In the event of either repeal of federal or of state laws and regulations, or of amendments thereto that are adverse to our intended products, we may be restricted or limited with respect to those products that we may sell or distribute, which could adversely impact our intended business plan with respect to such intended products.

Additionally, the FDA has indicated that certain products containing CBD are not permissible under the Federal Food, Drug, and Cosmetic Act (the “FDCA”), notwithstanding the passage of the Farm Bill. On December 20, 2018, after the Farm Bill became law, then FDA Commissioner Scott Gottlieb issued a statement in which he reiterated the FDA’s position that CBD products that are marketed with a claim of therapeutic benefit must be approved by the FDA for their intended use before they may be distributed in interstate commerce and that the FDCA prohibits interstate distribution of food products containing CBD and marketing products containing CBD as a dietary supplement, regardless of whether the substances are hemp-derived. Although we believe our existing and planned CBD products comply with applicable federal and state laws and regulations, legal proceedings alleging violations of such laws could have a material adverse effect on our results of operations and financial condition. Sources of hemp-derived CBD depend upon legality of cultivation, processing, marketing and sales of products derived from those plants under state law.

Hemp-derived CBD can only be legally produced in states that have laws and regulations that allow for such production and that comply with the Farm Bill, apart from state laws legalizing and regulating medical and recreational cannabis or marijuana, which remains illegal under federal law. This is one of the reasons why we are based in Colorado. Unexpected changes in federal and state law could cause our current CBD production methods or resulting products, as well as products that we intend to develop and launch, to be illegal or could otherwise prohibit, limit or restrict some or all of our products in the event of repeal or amendment of laws and regulations which are now comparatively favorable to the cannabis/hemp industry in certain states, we would be required to locate new suppliers in states with laws and regulations that qualify under the Farm Bill. If we were to be unsuccessful in arranging new sources of supply of our raw ingredients, or if our raw ingredients were to become legally unavailable, our intended business plan with respect to such products could be adversely impacted.

Because we and our distributors may only sell and ship our products containing hemp-derived CBD in states that have adopted laws and regulations qualifying under the Farm Bill, a reduction in the number of states having such qualifying laws and regulations could limit, restrict or otherwise preclude the sale of intended products containing hemp-derived CBD.

The interstate shipment of hemp-derived CBD from one state to another is legal only where both states have laws and regulations that allow for the production and sale of such products and that qualify under the Farm Bill. Therefore, the marketing and sale of our products is limited by such factors and is restricted to such states. Although we believe we may lawfully sell any of our finished products including those containing CBD in a majority of states, a repeal or adverse amendment of laws and regulations that are now favorable to the distribution, marketing and sale of finished products we intend to sell could significantly limit, restrict or prevent us from generating revenue related to our products that contain hemp-derived CBD. Additionally, any such adverse changes or existing legislation in new markets we target may stunt our growth and diminish our prospects. Any such repeal or adverse amendment of laws and regulations could have an adverse impact on our business plan with respect to such products.

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Costs associated with compliance with numerous laws and regulations and quality standards could adversely impact our financial results.

The manufacture, labeling and distribution of CBD products is regulated by various federal, state and local government agencies. These governmental authorities regulate our products and processes to ensure that the products are not adulterated or misbranded. We are subject to regulation by the federal government and other state and local agencies as a result of our CBD products. In addition to the risks associated with the possibility of government enforcement or private litigation due to alleged noncompliance, our compliance costs associated with our day-to-day operations are high and are expected to increase as we expand into new markets and/or develop and market new products. For example, as a “seed to sale” CBD business, meaning a business which handles every step of a CBD product’s manufacture and sale in-house rather than relying on third parties for some or all the production and distribution steps, we are responsible for the quality of our product, and the means by which it is produced and marketed, at every stage. Compliance with regulations imposed on our business model means we must deploy and maintain an advanced computer monitoring system which allows us to track our production and distribution process. We must train our employees and utilize and maintain security measures to ensure our facility functions properly. Compliance with these and other government requirements for product monitoring, quality, labelling and distribution are costly which may limit our profitability.

Our products or third parties with whom we do business may not comply with health, safety and labelling standards.

We do not have control over all of the third parties involved in the sale of our products and their compliance with government health, safety and labelling standards. Even if our products meet these standards, they could otherwise become contaminated or fail, or the standards could be changed in a manner adverse to our operations or those of our business partners. A failure to meet these standards could occur in our operations or those of our distributors or suppliers. This could result in expensive production interruptions, recalls, regulatory investigations and enforcement actions and liability claims. Moreover, negative publicity could be generated from false, unfounded or nominal liability claims or limited recalls. Any of these failures or occurrences could negatively affect our business and financial performance.

If we fail to comply with U.S. laws related to privacy, data security, and data protection, it could adversely affect our operating results and financial condition.

We rely on a variety of marketing techniques, including email, radio, display advertising, and social media marketing, targeted online advertisements, and postal mailings, and we are approvedor may become subject to various laws and regulations that govern such marketing and advertising practices. A variety of federal and state laws and regulations, including those enforced by various federal government agencies such as the Federal Trade Commission, Federal Communications Commission, and state and local agencies, govern the collection, use, retention, sharing, and security of personal data, particularly in the context of online advertising, which we utilize to attract new customers.

The legislative and regulatory bodies or self-regulatory organizations in various jurisdictions inside the United States may expand current laws or regulations, enact new laws or regulations, or issue revised rules or guidance regarding privacy, data protection, consumer protection, information security, and online advertising. California has enacted the California Consumer Privacy Act of 2018 (the “CCPA”), which became operative on January 1, 2020, and its implementing regulations took effect in August 2020. The CCPA requires companies that process personal information on California residents to make new disclosures to consumers about such companies’ data collection, use, and sharing practices and inform consumers of their personal information rights such as deletion rights, allows consumers to opt out of certain data sharing with third parties, and provides a new cause of action for sale,data breaches. In November 2020, California enacted the California Privacy Rights Act of 2020 (the “CPRA”), which amends and expands the scope of the CCPA, while introducing new privacy protections that extend beyond those included in the CCPA and its implementing regulations. The CCPA, as amended and expanded by the CPRA, is one of the most prescriptive general privacy law in the United States and may lead to similar laws being enacted in other U.S. states or at the federal level. For example, the State of Nevada also passed a law effective on October 1, 2019 that amends the state’s online privacy law to allow consumers to submit requests to prevent websites and online service providers (“Operators”) from selling personally identifiable information that Operators collect through a website or online service. Further, on March 2, 2021, the Governor of Virginia signed into law the Virginia Consumer Data Protection Act (the “VCDPA”). The VCDPA creates consumer rights, similar to the CCPA, but also imposes security and assessment requirements for businesses. In addition, on July 7, 2021, Colorado, the state in which we are headquartered, enacted the Colorado Privacy Act (“CoCPA”), becoming the third comprehensive consumer privacy law to be passed in the United States (after the CCPA and VCDPA). Although the CoCPA closely resembles the VCDPA, both of which do not contain a private right of action and will instead be enforced by the respective states’ Attorney General and district attorneys, the two differ in many ways and once they become enforceable in 2023, we must comply with each if our operations fall within the scope of these newly enacted comprehensive mandates. Prior efforts undertaken to comply with other recent privacy-related laws have proven that these initiatives require time to carefully plan, assess gaps in current compliance mechanisms, and implement new policies, processes and remediation efforts. Additionally, the Federal Trade Commission and state attorneys general are interpreting federal and state consumer protection laws to impose standards for the online collection, use, dissemination, and security of data. Each of these privacy, security, and data protection laws and regulations, and any other such changes or new laws or regulations, could impose significant limitations, require changes to our business model or practices, or restrict our use or storage of personal information, which may increase our compliance expenses and make our business more costly or less efficient to conduct. In addition, any such changes could compromise our ability to develop an adequate marketing strategy and pursue our growth strategy effectively, which, in turn, could adversely affect our business, financial condition, and results of operations.

While we intend to strive to comply with applicable laws and regulations relating to privacy, data security, and data protection, given that the scope, interpretation, and application of these laws and regulations are often uncertain and may be in conflict across jurisdictions, it is possible that these obligations may be interpreted and applied in a manner that is inconsistent from one jurisdiction to another and may conflict with other rules or our practices. Any failure or perceived failure by us or third-party service providers to comply with privacy or security policies or privacy-related legal obligations, or any compromise of security that results in the unauthorized release or transfer of personal data, may result in governmental enforcement actions, litigation, or negative publicity, and could have an adverse effect on our operating results and financial condition.

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Our planned expansion into international markets will involve inherent risks that we may not be able to commercialize any of these products. control.

Our products may not reachbusiness plan includes the market for a number of reasons, including:

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failure to obtain approvals for clinical trials or unsuccessful clinical trials;
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lack of familiarity of health care providers and patients;
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low market acceptance as a result of lower demonstrated safety or efficacy or otherdisadvantages relative to other available diagnostic products;
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insufficient or unfavorable coverage determinations or reimbursements from health plans, governments or third party payers;
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alleged infringement on proprietary rights of others related to our licenses;
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ineffectiveeventual marketing and distribution support;
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lacksale of cost-effectiveness; or
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timingour products in international markets. Specifically, we do not currently have a set time frame for entering these markets. Accordingly, our operating results could be materially and adversely affected by a variety of market introduction of competitive products.
If any of these potential problems occur, we may never successfully commercialize our product candidates, including FibriLyzer. uncontrollable and changing factors relating to international business operations, including:

Economic conditions adversely affecting geographic areas in which we intend to do business;
Foreign currency exchange rates;
Political or social unrest or economic instability in a specific country or region;
Higher costs of doing business in foreign countries;
Infringement claims on foreign patents, copyrights or trademark rights;
Difficulties in staffing and managing operations across disparate geographic areas;
Difficulties associated with enforcing agreements and intellectual property rights through foreign legal systems;
Trade protection measures and other regulatory requirements, which may affect our ability to import or export our products from or to various countries;
Adverse tax consequences;
Unexpected changes in legal and regulatory requirements and challenges in complying with varying requirements across jurisdictions; and
Military conflict, terrorist activities, natural disasters and medical epidemics.

If we are unable to develop commercially viable products,overcome these or other challenges in executing our business, results of operations and financial condition willplanned expansion into international markets, our prospects would be materially and adversely affected.

Risks Related to Intellectual Property

We may become involved in litigation or other proceedings relating to patent and other intellectual property rights.

A third party may sue us or our strategic collaborators for infringing its intellectual property rights. Likewise, we may need to resort to litigation to enforce licensed rights or to determine the scope and validity of third-party intellectual property rights. The cost to us of any litigation or other proceeding relating to intellectual property rights, even if resolved in our favor, could be substantial, and the litigation would divert our efforts. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have a history of operating losses,substantially greater resources. If we do not expectprevail in this type of litigation, we or our strategic collaborators may be required to be profitablepay monetary damages; stop commercial activities relating to the affected products or services; obtain a license in order to continue manufacturing or marketing the affected products or services; or attempt to compete in the near futuremarket with a substantially similar product. Uncertainties resulting from the initiation and our independent registered public accounting firm has expressed doubt as tocontinuation of any litigation could limit our ability to continue as a going concern.

We currently have no products available for sale, have not generated any revenues sincesome of our entry into the life sciences business and have incurred significant operating losses. We expect to incur additional operating losses for the foreseeable future.operations. In addition, a court may require that we expect thatpay expenses or damages, and litigation could distract management or disrupt our current cash levelscommercial activities.

If we become involved in intellectual property litigation, such litigation is likely to be expensive and time-consuming and could be unsuccessful.

Our commercial success will not be sufficient to enabledepend in part on our avoiding infringement on the patents and proprietary rights of third parties for products we license or sell. There is substantial litigation, both within and outside the United States, involving patent and other intellectual property rights in the health and wellness industry, including patent infringement lawsuits, interferences, oppositions, and reexaminations and other post-grant proceedings before the U.S. Patent and Trademark Office, and corresponding foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications which are owned by third parties may exist with products we may license and sell.

Parties making intellectual property claims against us to complete the development of any potential products, including FibriLyzer. See “We will need additional capital to conduct our operations and develop our products andmay obtain injunctive or other equitable relief, which could block our ability to obtain the necessary funding is uncertain.

Asfurther develop and commercialize one or more products. Defense of these claims, regardless of their merit, involves substantial litigation expense and would be a resultsubstantial diversion of our historymanagement’s attention from our business. If a claim of operating losses,infringement against us succeeds, we may have to pay substantial damages, possibly including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

To counter infringement or unauthorized use claims against us, we may be required to file infringement claims in response, or we may be required to defend the audit report prepared byvalidity or enforceability of any such intellectual property rights. In an infringement proceeding, a court may decide that either our independent registered public accounting firm relating to our financial statements for the year ended December 31, 2016 includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern.  The inclusion of the going concern statement by our auditors may adversely affect our stock price and our ability to raise needed capital or enter into advantageous contractual relationships with third parties. If we were unable to continue as a going concern, the values we receive for our assets on liquidationone or dissolution could be significantly lower than the values reflected in our financial statements.

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We will need additional capital to conduct our operations and develop our products and our ability to obtain the necessary funding is uncertain.
As of December 31, 2016, we had $1,055,336 of cash. Through 2016, we used a significant amount of cash to finance the developmentmore of our products,licensors’ intellectual property rights are not valid or is unenforceable or may refuse to stop the other party from using the underlying concepts or technology at issue because our intellectual property rights do not cover those elements. In any event, intellectual property litigation is expensive and we expect that our current levels of cash will not be sufficient to enable us to complete the development and commercialization of any potential products, including FibriLyzer and related technology. Based on our current sources of cash, including the proceeds received from our sale of securities to MagniSci Fund, LP and POC Capital’s commitment to fund up to $1 million in clinical trial costs, and on our internal projections, we believe that our current cash and cash equivalents will fund our business until the fourth quarter of 2017.
Changes in our business, whether or not initiated by us, could affect the rate at which we deplete our cash and cash equivalents,time consuming and we may be unsuccessful in managingdefending or enforcing such claims, which would materially harm our operations ortimingbusiness.

Any inability to protect our capital expenditures in a manner sufficient to sustain our operations in accordance with our expectations. The timing and degree of any future capital requirements will depend on many factors, including:

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intellectual property rights could reduce the accuracy of the assumptions underlying our estimates for capital needs in 2017 and beyond;
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scientific progress in our research and development programs;
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the magnitude and scopevalue of our researchproducts and development programsbrands, which could adversely affect our financial condition, results of operations and business.

Our business is partly dependent upon our ability to establish, enforcetrademarks, trade secrets, copyrights and maintain strategic arrangements for research, development, clinical testing, manufacturing and marketing;

● 
our progress with pre-clinical development and clinical trials;
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the time and costs involved in obtaining regulatory approvals; and
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the number and type of product candidates that we pursue.
Accordingly, we will need to obtain further funding through public or private equity offerings, debt financing, collaboration arrangements or other sources. Adequate additional fundingintellectual property rights. Effective intellectual property rights protection, however, may not be available under the laws of every country in which we and our sub-licensees may operate. There is a risk of certain valuable trade secrets being exposed to potential infringers. Regardless of whether our compounds and technology are or becomes protected by patents or otherwise, there is a risk that other companies may employ such compounds or technology without authorization and without recompensing us.

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The efforts we take to protect our proprietary rights may not be sufficient or effective. Any significant impairment of our intellectual property rights could harm our business or our ability to compete. In addition, protecting our intellectual property rights is costly and time consuming. There is a risk that we may have insufficient resources to counter adequately such infringements through negotiation or the use of legal remedies. It may not be practicable or cost effective for us on acceptable terms,to fully protect our intellectual property rights in some countries or at all.jurisdictions. If we are unable to raise capital,successfully identify and stop unauthorized use of our intellectual property, we will be forced to delay, reduce or eliminatecould lose potential revenue and experience increased operational and enforcement costs, which could adversely affect our researchfinancial condition, results of operations and development programsbusiness.

The intellectual property behind our products may include unpublished know-how, which is dependent on certain key individuals, as well as existing and may not be able to continue as a going concern.

We are currently completelypending intellectual property protection.

The commercialization of our products is partially dependent upon know-how and trade secrets held by certain individuals working with and for us. Because the successful development of our lead product candidate, FibriLyzer. If we failexpertise runs deep in these few individuals, if something were to successfully complete its development and commercialization, we will not generate operating revenues.

Almost all of our efforts are currently focused on the development of FibriLyzer. There also isno guarantee that we will succeed in developing FibriLyzer. If we are unablehappen to consummate the production and commercialization of FibriLyzer, we will be unable to generate any revenues. There is no certainty as to our success, whether within a given time frame or at all.
At present, we are manufacturing the key component of our disposable assay test strip, which is our proprietary synthetic fibrin clot that contains an electro-active polymer (“elactomer”) that creates electrical current as the fibrin clot is dissolved by enzymes in the blood, and expect to begin to manufacturing FibriLyzer devices in the second quarter of 2017. There is no guarantee that we will successfully develop products suitable for use in a clinical environment, and our failure to do so on a timely basis, or at all, may delay, prevent initiation or increase the costs of our planned clinical trials. Any delays in our schedule for clinical trials, regulatory approvals or other stages in the development of our technology are likely to cause us additional expense, and may even prevent the successful finalization of any or all of these individuals, the ability to properly manufacture our product candidates,products without compromising quality and performance could be diminished greatly. Further, [while our employees and contractors are subject to non-disclosure obligations,] any misappropriation of confidential information including trade secrets and know-how could allow our anticipated follow-up product, MatriLyzer. Delayscompetitors and others to overcome any advantage we have and reduce our market share and viability.

Risks Related to Our Securities and Our Status as an SEC Reporting Company

Because our Chief Executive Officer, directly and through entities she controls, beneficially owns approximately 61% of our issued and outstanding common stock and voting power on an as-converted basis, she can exert significant control over our business and affairs which may be averse to those of our stockholders, particularly if a conflict of interest arises.

Our Chief Executive Officer and currently one of our two directors, owns approximately 61% of our issued and outstanding shares of common stock and voting power on an as-converted basis. As of December 31, 2022, Ms. Buttorff and or her companies also hold $14.796 million in demand notes which bear interest at a rate ranging from 0 to 12% per annum. The interests of Ms. Buttorff may differ from the interests of our other stockholders, including by virtue of her other businesses operated through her entities and their holdings that are not affiliated with us. As a result, Ms. Buttorff will have significant influence and control over all corporate actions including those actions requiring stockholder approval, irrespective of how our minority stockholders may vote, including the following actions:

the election of our directors;
charter or bylaw amendments;
a merger, asset sale or other fundamental corporate transaction; and
any other matter submitted to our stockholders for a vote, subject only to applicable law including the Nevada Revised Statutes.

This concentration of ownership and the conflicts of interest may have the effect of impeding a merger, consolidation, takeover or other business combination or tender offer for our common stock which other stockholders may deem desirable or could reduce our stock price or prevent our stockholders from realizing a premium over our stock price in such a transaction. Further, to the extent our other stockholders disagree with an action Ms. Buttorff elects to take as a stockholder, their ability to prevent such action or avoid the effect on their shareholdings will range from significantly limited to non-existent due to our current capital structure, subject only to applicable law and our charter documents. Therefore, if Ms. Buttorff has an interest adverse to other stockholders, or if other stockholders otherwise disagree with Ms. Buttorff with respect to a matter before the stockholders, they will have little to no control over that matter and the direction we ultimately take.

The requirements of being a public company may strain our resources and distract our management, which could make it difficult to manage our business.

The federal securities laws require us to comply with SEC reporting requirements relating to our business and securities. Complying with these reporting and other regulatory obligations is time-consuming and will result in increased costs to us which could have a negative effect on our financial condition or business. These increased costs are not reflected in the timing for developmentfinancial statements contained in this Annual Report on Form 10-K because during the periods covered Panacea was a private company not subject to SEC reporting obligations.

As a public company, we are subject to the reporting requirements of the Exchange Act and the requirements of the Sarbanes-Oxley Act. These requirements may place a strain on our systems and resources. We are required to file annual, quarterly and current reports with the SEC disclosing certain aspects and developments of our technologybusiness and financial condition. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal controls over financial reporting. To maintain and improve the effectiveness of our disclosure controls and procedures, we will need to commit significant resources, hire additional executive officers and personnel and provide for additional management oversight. We intend to implement additional procedures and processes for the purpose of addressing the standards and requirements applicable to SEC reporting companies. Sustaining our growth will also require us to commit additional managerial, operational and financial resources to identifying competent professionals to join us and to maintain appropriate operational and financial systems to adequately support our intended expansion. These activities may alsodivert management’s attention from other business concerns, which could have a material adverse effect on our results of operations, financial condition or business.

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Due to factors beyond our control, our stock price may be volatile.

Any of the following factors could affect the market price of our common stock:

Our failure to generate increasing material revenues from our business;
Our failure to enhance our product offerings or expand into new markets;
A decline in our revenue or growth rate;
Our public disclosure of the terms of any financing which we consummate in the future;
A decline in the economy which impacts the demand for our products and our ability to generate revenue and achieve growth metrics;
Announcements by us or our competitors of significant contracts, new products, acquisitions, commercial relationships, joint ventures or capital commitments;
Changes in laws, regulations or government actions affecting the cannabinoid industry in general or our products in particular;
Our ability to list our common stock on a national securities exchange;
Our ability to attract analyst coverage;
The sale of large numbers of shares of common stock by our shareholders;
Short selling activities; or
Changes in market valuations of similar companies.

In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted. A securities class action suit against us could result in substantial costs and divert our management’s time and attention, which would otherwise be used to benefit our business.
These broad market and industry factors may have a material adverse effect on the market price of our common stock, regardless of our actual operating performance. These factors could
have a material adverse effect on our business, financial condition and results of operations due to the possible absence of financing sources for our operations during such additional periods of time. Although we may pursue other technologies (either developed in-house or acquired), there is no assurance that any other technology will be successfully identified or exploited.

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Our business is highly dependent upon maintaining licenses with respect to key technology.
Our business substantially depends on licenses from third parties, including the Licensing Agreement with Digital Diagnostics. These third party license agreements impose obligations on us, such as payment obligations and obligations to diligently pursue, and cooperate with third parties in, the development, regulatory approval, manufacture and commercialization of products under the licensed patents. If a licensor believes that we have failed to meet our obligations under a license agreement, the licensor could seek to limit or terminate our license rights, which could lead to costly and time consuming litigation and, potentially, a loss of the licensed rights. The loss of any of such licenses, or the conversion of such licenses to non-exclusive licenses, could harm our operations and/or enhance the prospects of our competitors.
In addition, certain of the technology that we license from Digital Diagnostics is sub-licensed from other third parties, including the University of Queensland. If Digital Diagnostics fails to perform its obligations under the licenses pursuant to which it has licensed the intellectual property that is licensed to us, our rights to key technology could be jeopardized. In addition, certain of these licenses are governed by the laws of foreign countries such as Australia. These foreign laws may differ significantly from laws in the United States and, as a result, our ability to assess or enforce our rights under such agreements may be limited compared with our ability to assess or enforce our rights under agreements governed by laws in the United States.
If we or our licensors fail to meet our respective obligations under a license agreement, or if the owner of the intellectual property otherwise seeks to terminate these agreements, costly and time consuming litigation could result. During the period of any such litigation, our ability to carry out the development and commercialization of potential products could be significantly and negatively affected. Further, if our license rights were restricted, ultimately lost, or became non-exclusive, our ability to continue our business based on FibriLyzer and the related technology could be severely affected adversely.
We may be unable to obtain or maintain patent or other intellectual property protection for any products or processes that we may develop.
We face risks and uncertainties related to intellectual property rights. We may be unable to obtain or maintain our patents or other intellectual property protection for any products or processes that we may have or may develop; third parties may obtain patents covering the manufacture, use or sale of these products or processes which may prevent us from commercializing our technology; or any patents that we have or may obtain may not prevent other companies from competing with us by designing their products or conducting their activities so as to avoid the coverage of our patents.
In addition, the growth of our business may depend in part on our ability to acquire or in-license additional proprietary rights. For example, our programs may involve additional product candidates that may require the use of additional proprietary rights held by third parties. We may be unable to acquire or in-license any relevant third-party intellectual property rights that we identify as necessary or important to our business operations. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all, which would harm our business. We may need to cease use of the compositions or methods covered by such third-party intellectual property rights, and may need to seek to develop alternative approaches that do not infringe on such intellectual property rights which may entail additional costs and development delays, even if we were able to develop such alternatives, which may not be feasible. Even if we are able to obtain a license under such intellectual property rights, any such license may be non-exclusive, which may allow our competitors access to the same technologies licensed to us.
The licensing and acquisition of third-party intellectual property rights is a competitive practice, and companies that may be more established, or have greater resources than we do, may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider necessary or attractive in order to commercialize our product candidates. More established companies may have a competitive advantage over us due to their larger size and cash resources or greater clinical development and commercialization capabilities. There can be no assurance that we will be able to successfully protect or acquire the rights to the intellectual property to commercialize our product candidates.
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Clinical trials involve lengthy and expensive processes with uncertain outcomes, and if we are unable to satisfactorily complete such testing, or if such testing yields unsatisfactory results, we may be unable to commercially produce our proposed products.
We cannot predict whether we will encounter problems with any of our planned clinical trials, which would cause us or regulatory authorities to delay or suspend clinical trials, or delay the analysis of data from ongoing clinical trials. We anticipate submitting a premarket notification to the FDA for FibriLyzer as Class II device pursuant to Section 510(k) of the FDAC and anticipate that we will be eligible to market and sell products by the end of 2018; however, such trials may also take significantly longer to complete and may cost more money than we expect. Failure can occur at any stage of testing, and we may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent commercialization of the current, or a future, more advanced, version of our product candidates.
A number of companies in the medical device, biotechnology, and biopharmaceutical industries including those with greater resources and experience than us have suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier clinical trials. We do not know whether any clinical trials we or any future clinical partners may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market FibriLyzer or MatriLyzer. If our clinical trials do not produce favorable results, we may be required to perform additional clinical trials or our ability to obtain regulatory approval may be adversely impacted, either of which may have an adverse material effect on our business, financial condition and the results of our operations.
Even if we are successful in developing FibriLyzer and other products using our technologies, it is unclear whether these products can serve as the foundation for a commercially viable and profitable business.
Life sciences technology is developing and rapidly could undergo significant changes in the future. Such rapid technological developments could result in our technologies becoming obsolete. While we believe our product candidates appear promising, they may fail to be successfully commercialized for numerous reasons, including, but not limited to, competing technologies for the same applications. In addition, our ability to commercialize our products into a profitable business depends on our ability to develop and maintain marketing and sales personnel and distribution capabilities, which we currently do not have. Thus, even if we are able to develop successfully and commercially market FibriLyzer and other products using our technologies, there can be no assurance that we will be able to develop a commercially successful and profitable business based on these technologies.
Moreover, advances in other treatment methods or prevention techniques could significantly reduce or entirely eliminate the need for our technologies and planned products. As a result, technological or medical developments may materially alter the commercial viability of our technology or services, and require us to incur significant costs to replace or modify equipment in which we have a substantial investment.

We are focused on Point-of-Care blood diagnostic products, and if this field is substantially unsuccessful, this outcome could jeopardize our success or future results. The occurrence of any of these factors may have a material adverse effect on our business, operating results and financial condition.

If competitors develop and market products that are more effective, safer, or less expensive than our product candidates or offer other advantages, our commercial prospects will be limited.
We currently are not aware of other companies developing a handheld Point-of-Care device to measure fibrinolysis; however, there are other companies that currently manufacture and sell diagnostic tools for measuring other components of blood and coagulation. Any of these companies could begin to develop a competing product.We expect that our diagnostic products will face intense competition from biotechnology companies, as well as numerous academic and research institutions and governmental agencies engaged in medical device discovery activities or funding, both in the United States and abroad. Some of these competitors are pursuing the development of products or devices that target the same diseases and conditions that we are targeting with our product candidates.
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As a general matter, we also face competition from many companies that are researching and developing blood diagnostic products. Many of these companies have financial and other resources substantially greater than ours. In addition, many of these competitors have significantly greater experience in testing products, obtaining regulatory approvals, and marketing and selling. If we ultimately obtain regulatory approval for any of our product candidates, we also will be competing with respect to manufacturing efficiency and marketing capabilities, areas in which we have limited or no commercial-scale experience. Competition may increase further as a result of advances made in the commercial applicability of our technologies and greater availability of capital for investment in these fields. Our competitors may develop more competitive or affordable products, or achieve earlier patent protection or product commercialization than we are able to achieve. Competitive products may render any products or product candidates that we develop uneconomic or obsolete. The occurrence of any of these factors may have a material adverse effect on our business, operating results and financial condition.
If we are unable to keep up with rapid technological changes in our field or compete effectively, we will be unable to operate profitably.
We are engaged in activities in the biotechnology field, which is characterized by extensive research efforts and rapid technological progress. If we fail to anticipate or respond adequately to technological developments, our ability to operate profitably could suffer. Research and discoveries by other biotechnology, agricultural, pharmaceutical or other companies may render our technologies or potential products or services uneconomical or result in products superior to those we develop. Similarly, any technologies, products or services we develop may not be preferred to any existing or newly developed technologies, products or services.
The development and commercialization of our product candidates is subject to extensive regulation by the FDA and other regulatory agencies in the United States and abroad, and the failure to receive regulatory approvals for our other product candidates would likely have a material and adverse effect on our business and prospects.
The process of obtaining FDA and other regulatory approvals is expensive and is subject to numerous risks and uncertainties.We intend to file to gain regulatory approval to sell our products in the United States, Canada and Europe.Changes in regulatory approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application or may make it easier for our competitors to gain regulatory approval to enter the marketplace. Ultimately, the FDA and other regulatory agencies have substantial discretion in the approval process and may refuse to accept any application or may decide that our product candidate data are insufficient for approval without the submission of additional pre-clinical, clinical or other studies. In addition, varying agency interpretations of the data obtained from pre-clinical and clinical testing could delay, limit or prevent regulatory approval of a product candidate. Any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.
Any of the following factors, among others, could cause regulatory approval for our product candidates to be delayed, limited or denied:
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the product candidates require significant clinical testing to demonstrate safety and effectiveness before applications for marketing approval can be filed with the FDA and other regulatory authorities;
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data obtained from pre-clinical and clinical trials can be interpreted in different ways, and regulatory authorities may not agree with our respective interpretations or may require us to conduct additional testing;
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negative or inconclusive results or the occurrence of serious or unexpected adverse events during a clinical trial could cause us to delay or terminate development efforts for a product candidate; and/or
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FDA and other regulatory authorities may require expansion of the size and scope of the clinical trials.
Any difficulties or failures that we encounter in securing regulatory approval for our product candidates would likely have a substantial adverse impact on our ability to generate product sales, and could make any search for a collaborative partner more difficult.
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We may be unsuccessful in our efforts to comply with applicable federal, state and international laws and regulations, which could result in loss of licensure, certification or accreditation or other government enforcement actions or impact our ability to secure regulatory approval of our product candidates.
Although we seek to conduct our business in compliance with applicable governmental healthcare laws and regulations, these laws and regulations are exceedingly complex and often subject to varying interpretations. As such, there can be no assurance that we will be able, or will have the resources, to maintain compliance with all such healthcare laws and regulations. Failure to comply with such healthcare laws and regulations, as well as the costs associated with such compliance or with enforcement of such healthcare laws and regulations, may have a material adverse effect on our operations or may require restructuring of our operations or impair our ability to operate profitably.
We will continue to be subject to extensive regulation by the FDA and other regulators abroad following any product approvals, and if we fail to comply with these regulations, we may suffer a significant setback in our business.
Even if we are successful in obtaining regulatory approval of our product candidates, we will continue to be subject to the requirements of and review by, the FDA and comparable regulatory authorities abroad in the areas of manufacturing processes, post-approval clinical data, adverse event reporting, labeling, advertising and promotional activities, among other things. In addition, any marketing approval we receive may be limited in terms of the approved product indication or require costly post-marketing testing and surveillance. Discovery after approval of previously unknown problems with a product, manufacturer or manufacturing process, or a failure to comply with regulatory requirements, may result in actions such as:
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warning letters or other actions requiring changes in product manufacturing processes or restrictions on product marketing or distribution;
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product recalls or seizures or the temporary or permanent withdrawal of a product from the market; and
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federal and state investigations, fines, restitution or disgorgement of profits or revenue, the imposition of civil penalties or criminal prosecution.
The occurrence of any of these actions would likely cause a material adverse effect on our business, financial condition and results of operations.
We depend on our collaborators to help us develop and test our proposed products, and our ability to develop and commercialize products may be impaired or delayed if collaborations are unsuccessful.
Our strategy for the development, clinical testing, manufacture and commercialization of our proposed products requires that we enter into collaborations with corporate partners, licensors, licensees and others. We are dependent upon the subsequent success of these other parties in performing their respective responsibilities and the continued cooperation of our partners. Our collaborators may not cooperate with us or perform their obligations under our agreements with them. We cannot control the amount and timing of our collaborators’ resources that will be devoted to our research and development activities related to our collaborative agreements with them. Our collaborators may choose to pursue existing or alternative technologies in preference to those being developed in collaboration with us.
The development, manufacture and commercialization of potential products will be delayed if collaborators fail to conduct these activities in a timely manner, or at all. In addition, our collaborators could terminate their agreements with us. If we do not achieve milestones set forth in the agreements, or if our collaborators breach or terminate their collaborative agreements with us, our business may be materially harmed.
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Our products may be expensive to manufacture, and they may not be profitable if we are unable to control the costs to manufacture them.
We do not own or operate manufacturing facilities for production of our product candidates. As a result, we plan to outsource the manufacturing of our products, and have collaborated with a successful multi-national corporation in Taipei, Taiwan, to manufacture our products, including FibriLyzer. Manufacturers of medical device products often encounter difficulties in production, particularly in scaling up initial production. These problems include difficulties with production costs and yields and quality control, including stability of the product candidate. The occurrence of any of these problems could significantly delay our clinical trials or the commercial availability of our products.
Our reliance on a single source to manufacture our products entails risks, including:
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reliance on the third party for regulatory compliance and quality assurance;
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limitations on supply availability resulting from capacity and scheduling constraints of the third parties;
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impact on our reputation in the marketplace if manufacturers of our products, once commercialized, fail to meet the demands of our customers; and
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impact of a catastrophic event at the third party manufacturing facility on our ability to meet the demands of our customers.
The failure of any of our contract manufacturers to maintain high manufacturing standards could result in product liability claims, product recalls, product seizures or withdrawals, delays or failures in testing or delivery, cost overruns or other problems that could seriously harm our business or profitability.
Our contract manufacturers are required to adhere to FDA regulations. These regulations cover all aspects of the manufacturing, testing, quality control and recordkeeping relating to our product candidates and any products that we may commercialize. Our manufacturers may not be able to comply with applicable FDA regulations or similar regulatory requirements outside the United States. Our failure or the failure of our third party manufacturers, to comply with applicable regulations could significantly and adversely affect regulatory approval and supplies of our product candidates.
Our current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to develop product candidates and commercialize any products that obtain regulatory approval on a timely and competitive basis. In addition, we may not be able to charge a high enough price for any product we develop, even if they are safe and effective, to make a profit. If we are unable to realize significant profits from our potential product candidates, our business would be materially harmed.
Contractual arrangements with licensors or collaborators may require us to pay royalties or make other payments related to the development of a product candidate, which would adversely affect the level of our future revenues and profits.
Even if we obtain all applicable regulatory approvals and successfully commercialize FibriLyzer and other products utilizing our technologies, contractual arrangements between us and a licensor, collaborator or other third party in connection with the respective product may require that we make royalty or other payments to the respective third party, and as a result we would not receive all of the revenue derived from commercial sales of such product.
Cybersecurity breaches could expose us to liability, damage our reputation, compromise our confidential information or otherwise adversely affect our business.
We maintain sensitive company data on our computer networks, including our intellectual property and proprietary business information. We face a number of threats to our networks from unauthorized access, security breaches and other system disruptions. Despite our security measures, our infrastructure may be vulnerable to attacks by hackers or other disruptive problems. Any such security breach may compromise information stored on our networks and may result in significant data losses or theft of our intellectual property or proprietary business information. A cybersecurity breach could hurt our reputation by adversely affecting the perception of customers and potential customers of the security of their orders and personal information. In addition, a cybersecurity attack could result in other negative consequences, including disruption of our internal operations, increased cyber security protection costs, lost revenues or litigation.
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We depend on key personnel for our continued operations and future success, and a loss of certain key personnel could significantly hinder our ability to move forward with our business plan.
Because of the specialized nature of our business, we are highly dependent on our ability to identify, hire, train and retain highly qualified scientific and technical personnel for the research and development activities we conduct or sponsor. The loss of one or more key executive officers, or scientific officers, would be significantly detrimental to us. In addition, recruiting and retaining qualified scientific personnel to perform research and development work is critical to our success. Our anticipated growth and expansion into areas and activities requiring additional expertise, such as clinical testing, regulatory compliance, manufacturing, marketing and distribution, will require the addition of new management personnel and the development of additional expertise by existing management personnel. There is intense competition for qualified personnel in the areas of our present and planned activities. Accordingly, we may not be able to continue to attract and retain the qualified personnel, which would adversely affect the development of our business.
Our failure to maintain effective internal controls over financial reporting may adversely affect the accuracy and timeliness of our financial reporting.
As described in “Part II, Item 9A. Controls and Procedures” included in this annual report on Form 10-K for the year ended December 31, 2016, we disclosed a material weaknesses in our disclosure controls and procedures and in our internal controls over financial reporting due to our small size and limited resources. While we are continuing to work to improve our internal controls, we cannot be certain that these measures will ensure that we implement and maintain adequate controls over our financial processes and reporting in the future. Any failure to implement or maintain effective controls, or difficulties encountered in their implementation or improvement, could cause us to fail to meet our reporting obligations or could result in a material misstatement to our financial statements or other disclosures, either of which could have an adverse effect on our business, financial condition or results of operations.
We may be subject to litigation that will be costly to defend or pursue and uncertain in its outcome.
Our business may bring us into conflict with our licensors, collaborators or others with whom we have contractual or other business relationships, or with our competitors or others whose interests differ from ours. In addition, third parties could claim that our licensed technology or other technology relevant to or required by our expected products infringes on their intellectual property. If we are unable to resolve those conflicts on terms that are satisfactory to all parties, we may become involved in litigation brought by or against us. That litigation is likely to be expensive and may require a significant amount of management’s time and attention, at the expense of other aspects of our business. The outcome of litigation is always uncertain, and in some cases could include judgments against us that require us to pay damages, enjoin us from certain activities, or otherwise affect our legal or contractual rights, which could have a significant adverse effect on our business.
Risks Related to the Securities Markets and Our Capital Structure
An active trading market for our common stock has not developed, and the market price for our common stock has been and may continue to be particularly volatile given the lack of liquidity and our status as a relatively unknown company with a limited operating history and lack of profits.
Although our common stock is quoted on the OTC Markets Group’s OTCQB tier, an active trading market has not developed for our common stock, and we cannot assure you that an active, public trading market for our common stock will develop or be sustained. If an active public trading market does not develop or is not maintained, significant sale of our common stock, or the expectation of these sales, could materially and adversely affect the market price of our common stock. In addition, holders of our common stock may experience difficulty in reselling, or an inability to sell, their shares.
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In addition, the market for our common stock may be characterized by significant price volatility when compared to seasoned issuers, and we expect that our stock price could continue to be more volatile than a seasoned issuer for the indefinite future. The potential volatility in our share price is attributable to a number of factors. First, as a consequence of the lack of liquidity in our common stock, any future trading of shares by our stockholders may disproportionately influence the price of those shares in either direction. Second, we are a speculative or “risky” investment due to our limited operating history and lack of profits to date, and uncertainty of future market acceptance for our potential products. As a consequence of this enhanced risk, more risk averse investors may, under the fear of losing all or most of their investment in the event of negative news or lack of progress, be more inclined to sell their shares on the market more quickly and at greater discounts than would be the case with the stock of a seasoned issuer.
Many of these factors will be beyond our control and may decrease the market price of our common stock, regardless of our operating performance. We cannot make any predictions or projections as to what the prevailing market price for our common stock will be at any time or as to what effect that the sale of shares or the availability of shares for sale at any time will have on the prevailing market price. This market volatility, as well as general domestic or international economic, market and political conditions, could materially and adversely affect the market price of our Securities.
The rights of holders of our common stock are subordinate to significant rights, preferences and privileges of our existing series of preferred stock, and to any additional series of preferred stock created in the future.
Under the authority granted by our Articles of Incorporation, our Board of Directors has established four separate series of outstanding preferred stock, including Series A, Series B-1, Series B-2 and Series C Preferred Stock, which have various rights and preferences senior to the shares of common stock. As a result of the liquidation preferences, in the event that we voluntarily or involuntary liquidate, dissolve or windup our affairs (including as a result of a merger), the holders of our preferred stock would be entitled to receive stated amounts per share, including any accrued and unpaid dividends, before any distribution of assets or merger consideration is made to holders of our common stock. Additionally, subject to the consent of the holders of our existing preferred stock, our Board of Directors has the power to issue additional series of preferred stock and to designate, as it deems appropriate (subject to the rights of the holders of the current series of preferred stock), the special dividend, liquidation or voting rights of the shares of those additional series. The creation and designation of any new series of preferred stock could adversely affect the voting power, dividend, liquidation and other rights of holders of our common stock and, possibly, any other class or series of stock that is then in existence.
Shares eligible for future sale may adversely affect the market.
From time to time, certain of our stockholders may be eligible to sell all or some of their shares of common stock by means of ordinary brokerage transactions in the open market pursuant to Rule 144 promulgated under the Securities Act of 1933, as amended, subject to certain limitations. In general, pursuant to Rule 144, a stockholder (or stockholders whose shares are aggregated) who is not an affiliate of our company and who has satisfied a six month holding period may, as long as we are current in our required filings with the SEC, sell securities without further limitation. Rule 144 also permits, under certain circumstances, the sale of securities, without any limitations, by a non-affiliate of our company who has satisfied a one year holding period. Affiliates of our company who have satisfied a six month holding period may sell securities subject to limitations. Any substantial sale of our common stock pursuant to Rule 144 or pursuant to any resale prospectus may have an adverse effect on the market price of our securities. Currently, a substantial majority of our securities are either free trading or subject to the release of trading restrictions under the six month or one year holding periods of Rule 144.
The sale or issuance of a substantial number of shares may adversely affect the market price for our common stock.
The future sale of a substantial number of shares of our common stock in the public market, or the perception that such sales could occur, could significantly and negatively affect the market price for our common stock. Our Amended and Restated Articles of Incorporation authorize us to issue 200,000,000 shares of common stock and, as of December 31, 2016, there were 34,071,862 shares of our common stock outstanding, and we have reserved 14,784,001 shares of our common stock for the potential issuance of shares upon the conversion of outstanding preferred stock or the exercise of warrants. We expect that we will likely issue a substantial number of shares of our capital stock in financing transactions in order to fund our operations and the growth of our business. Under these arrangements, we may agree to register the shares for resale soon after their issuance. We may also continue to pay for certain goods and services with equity, which would dilute our current stockholders. Also, sales of the shares issued in this manner could negatively affect the market price of our stock.
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Our common stock may be subject to the “penny stock” rules ofwhich will adversely affect the SEC, and the trading market inliquidity of our common stock is limited,stock.

The SEC has adopted regulations which makes transactions cumbersome and may reduce the value of an investment in the stock.

Rule 15g-9 under the Exchange Act establishes the definition of agenerally define “penny stock” for the purposes relevant to us, as anybe an equity security that has a market price of less than $5.00 per share, subject to specific exemptions. The market price of our common stock on the OTCQB is presently less than $5.00 per share and therefore we are considered a “penny stock” company according to SEC rules. While we intend to effect a reverse stock split pending compliance with SEC Rules, including the filing of a Schedule 14C, to increase our stock price, until such time as our stock price rises above $5.00 per share (which may not occur following the reverse stock split or at all), the “penny stock” designation requires any broker-dealer selling our securities to disclose certain information concerning the transaction, obtain a written agreement from the purchaser and determine that the purchaser is reasonably suitable to purchase the securities. These rules limit the ability of broker-dealers to solicit purchases of our common stock and therefore reduce the liquidity of the public market for our shares.

Broker-dealers are increasingly reluctant to permit investors to buy or sell speculative unlisted stock and often impose costs which make it uneconomical for small shareholders to do so. Moreover, as a result of apparent regulatory pressure from the SEC and the Financial Industry Regulatory Authority (“FINRA”) a growing number of broker-dealers decline to permit investors to purchase and sell or otherwise make it difficult to sell shares of penny stocks. The “penny stock” designation may have a depressive effect upon our common stock price which the prospective reverse stock split may not sufficiently overcome.

Our ability to continue as a going concern is in doubt unless we obtain adequate new debt or equity financing and achieve sufficient sales levels.

As noted above, we have incurred significant net losses to date. We anticipate that we will continue to lose money for the foreseeable future. Additionally, we have negative cash flows from operations and we our revenue may exceed our expenses in the next 12 months. Since our inception in 2017, we have generated losses from operations. As of December 31, 2021, our accumulated deficit was $16.7 million, and we had $3.8 million in cash and liquid stock. Our continued existence is dependent upon generating sufficient working capital and obtaining adequate new debt or equity financing. These factors raise doubt about our ability to continue as a going concern for a period of 12 months from the issuance date of this report. Management cannot provide assurance that we will ultimately achieve or maintain profitable operations or become cash flow positive or raise additional debt and/or equity capital. Because of our continuing losses, without improvements in our cash flow from operations or new financing, we may have to continue to restrict our expenditures. Working capital limitations may impinge on our day-to-day operations, which may contribute to continued operating losses.

Operational risks such as material weaknesses and other deficiencies in internal control over financial reporting could result in errors, potentially requiring restatements of our historical financial data, leading investors to lose confidence in our reported results.

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There are a number of factors that may impede our efforts to establish and maintain effective internal controls and a sound accounting infrastructure, including our lacking a Chief Financial Officer, our pace of growth, and general uncertainty regarding the operating effectiveness and sustainability of controls. Controls and procedures, no matter how well designed and operated, provide only reasonable assurance that material errors in our financial statements will be prevented or detected on a timely basis. Any failure to establish and maintain effective internal controls over financial reporting increases the risk of material error and/or delay in our financial reporting. Depending on the nature of a failure and any required remediation, ineffective controls could have a material adverse effect on our business and potentially result in additional restatements of our historical financial results. Financial restatements or other issues arising from ineffective controls and our recent change of our auditors could also cause investors to lose confidence in our reported financial information, which would have an adverse effect on the trading price of our securities. Delays in meeting our financial reporting obligations could affect our ability to maintain the listing of our securities. Although we seek to reduce these risks through active efforts relating to properly documented processes, adequate systems, risk culture, compliance with regulations, corporate governance and other factors supporting internal controls, such procedures may not be effective in limiting each of the operational risks.

Potential Impacts of the COVID-19 Pandemic on Our Business Operations

As disclosed in Note 2 to our consolidated financial statements, the COVID-19 pandemic has had a notable impact on general economic conditions, including but not limited to the temporary closures of many businesses, “shelter in place” and other governmental regulations, reduced business and consumer spending due to both job losses and reduced investing activity, among many other effects attributable to the COVID-19 pandemic, and there continue to be many unknowns.

Potential Impacts of Certain Current and Proposed Regulations on Our Business and Operations

A bill titled the Cannabis Administration and Opportunity Act, put forward by Senate Majority leader Chuck Schumer, D-NY, would amend the definition of a dietary supplement to remove the prohibition on marketing CBD as a dietary supplement. Management sees the bill, if enacted, as an exerciseopportunity for the FDA to accelerate their decision to classify CBD products as a dietary supplement. This would be a significant step for hemp/CBD companies as it would open the door to new selling opportunities, such as getting into retail stores, who have largely been hesitant to welcome CBD in their doors without a clear position from the FDA.

Many people are increasingly turning to CBD products for several reasons: CBD is non-psychoactive, so it does not produce a “high” like THC, there are few known contraindications, the properties of different cannabinoids can positively affect a wide range of ailments, and cannabinoids work directly and indirectly with the body’s endocannabinoid system to create balance known as homeostasis. As demand increases, we believe the FDA must provide more clarity about CBD’s legalization, and this bill is a promising first step.

For now, many companies that produce hemp-derived CBD products including us undertake to abide by the same regulations as any other dietary supplements like ingredient filings, good manufacturing practices (GMP), and labeling and marketing provisions. We will continue to sell CBD and other hemp-derived products while still awaiting a clear path from the FDA about how CBD products can be marketed and used.

Item 1B. Unresolved Staff Comments

None.

Item 2. Properties

XXII has allocated 10 acres of the Needle Rock Farm in Delta County, CO to Panacea. We also lease our laboratory space at 16194 West 45th Drive, Golden, CO 80403 from J&N Real Estate Company, LLC which is owned by its CEO. See Note 5 to our consolidated financials.

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Item 3. Legal Proceedings

We have sued Defendants, Mike Fisher, in his official capacity as Osage County District Attorney ex rel. State of Oklahoma as an investigating and/or prosecuting body, Eddie Virden in his official capacity as the Sheriff of the City of Osage as holder of the property, and the City of Pawhuska as the property seizing body, (collectively the “Government Defendants”) for the return of approximately 17,000 pounds of industrial hemp (the “Property”). We believe we were entitled to possession of the Property pursuant to an August 23, 2018, contract between us and Blue Circle Development, LLC (“BCD”), wherein we agreed to pay and BCD agreed to deliver the Property according to certain terms. Plaintiff performed pursuant to the contract and is entitled to possession of the Property. We believe the Government Defendants wrongfully detained the Property and is responsible for damages to the Property and to us. On or about May 4, 2020, the Government Defendants improperly released the Property to BCD in violation of a Court Order. We have asserted claims against the Government Defendants for interference with the Court Order and BCD for improperly intercepting the Property from us. The case is currently set for a trial date in March 2023.

On February 16, 2021, Henley Group, Inc. filed with the Superior Court of the State of California, San Bernardino County, a complaint (Case #: SIV SB 2105771) against us for breach of contract and fraud related to our non-delivery of product. While we refunded the purchase price, the plaintiff seeks damages including lost profits and costs which plaintiff alleged to have incurred in the amount of approximately $45,000 as well as lost profits from expected future contracts with a prospective third-party buyer which plaintiff alleged to be $720,000. The plaintiff also seeks attorney’s fees and costs, consequential damages and punitive damages. This case was dismissed in May, 2022.

On October 7, 2019, CMI Mechanical (“CMI”) agreed to procure, deliver, and install a dehumidification system (the “System”) at our facility located at 16194 W. 45th Drive, Golden, Colorado 80403 (the “Property”). We believe the System has failed to meet the requirements of the subject contract, and CMI has not remedied that failure for us. We withheld certain payments as permitted under the contract. On December 10, 2020, CMI recorded a lien against the Property in the amount of $108,001.48. On January 27, 2021, the Panacea’s attorney notified CMI that its lien was invalid, overstated, and violated the terms of the contract. The letter also demanded that CMI remove the system at CMI’s own cost. The lien was since dropped. We settled this dispute in February 2022.

Item 4. Mine Safety Disclosures

Not applicable.

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PART II

Item 5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Market Information

Our Common Stock is quoted on the OTCQB over-the-counter market under the symbol “PLSH.” Over-the-counter market quotations reflect inter-dealer prices, without retail mark-up, mark-down or commissions and may not necessarily represent actual transactions. On March 28, 2023 the closing bid price on the OTC Markets for our Common Stock was $0.249.

Penny Stock

The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a market price of less than $5.00, per share, subjectother than securities registered on certain national securities exchanges or quoted on the NASDAQ system, provided that current price and volume information with respect to certain exceptions. For anytransactions in such securities is provided by the exchange or system. The penny stock rules require a broker-dealer, prior to a transaction involvingin a penny stock, unless exempt,to deliver a standardized risk disclosure document prepared by the rules require: (i) thatSEC, that: (a) contains a broker or dealer approve a person’s accountdescription of the nature and level of risk in the market for transactions in penny stocks in accordance withboth public offerings and secondary trading; (b) contains a description of the provisions of Rule 15g-9 under the Exchange Act; and (ii) the brokerbroker’s or dealer receive from the investor a written agreementdealer’s duties to the transaction, setting forth the identitycustomer and quantity of the penny stock to be purchased, provided that any such purchase shall not be effected less than two business days after the broker or dealer sends such written agreementrights and remedies available to the investor.

In ordercustomer with respect to approve a person’s accountviolation of such duties or other requirements of the securities laws; (c) contains a brief, clear, narrative description of a dealer market, including bid and ask prices for transactionspenny stocks and the significance of the spread between the bid and ask price; (d) contains a toll-free telephone number for inquiries on disciplinary actions; (e) defines significant terms in the disclosure document or in the conduct of trading in penny stocks,stocks; and (f) contains such other information and is in such form, including language, type size and format, as the brokerSEC shall require by rule or dealer must: (i) obtain financial information, investment experience and investment objectives of the person; and (ii) make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial mattersregulation.

The broker-dealer also must provide, prior to be reasonably expected to be capable of evaluating the risks of transactions in penny stocks.

The broker or dealer must also deliver, prior toeffecting any transaction in a penny stock, a disclosure schedule prescribed by the SECcustomer with (a) bid and offer quotations for the penny stock; (b) the compensation of the broker-dealer and its salesperson in the transaction; (c) the number of shares to which such bid and ask prices apply, or other comparable information relating to the penny stockdepth and liquidity of the market which: (i) sets forth the basis on which the broker or dealer made the suitability determination;for such stock; and (ii) in highlight form, confirms that the broker or dealer received(d) a signed, written agreement from the investor prior to the transaction. Generally, brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more difficult for investors to dispose of our common stock and cause a decline inmonthly account statement showing the market value of our common stock.
each penny stock held in the customer’s account.

In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from those rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written acknowledgment of the receipt of a risk disclosure statement, a written agreement as to transactions involving penny stocks, and a signed and dated copy of a written suitability statement.

These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for the shares of common stock. Consequently, it may be more difficult to execute trades of our common stock which may have an adverse effect on the liquidity of our common stock.

The conversion Therefore, stockholders may have difficulty selling our securities.

Holders of preferred stock or exerciseOur Common Stock

As of outstanding warrants to acquireMarch 28, 2023, we had 14,965,317 shares of our common stock issued and outstanding, and approximately 186 shareholders on record.

Dividends

There are no restrictions in our articles of incorporation or bylaws that prevent us from declaring dividends. The Nevada Revised Statutes, however, do prohibit us from declaring dividends where after giving effect to the distribution of the dividend:

1. We would cause additional dilution which could causenot be able to pay our debts as they become due in the priceusual course of business, or;

2. Our total assets would be less than the sum of our common stocktotal liabilities plus the amount that would be needed to decline.

Eachsatisfy the rights of our Series B-1, Series B-2 and Series C Preferred Stock is convertible into shares of our common stock. In addition, we issued warrants, pursuant to which shares of our common stock may be acquired. At December 31, 2016, there were 13,117,334 shares of our common stock underlying shares of preferred stock and 1,666,667 shares of common stock underlying the warrants, for which weshareholders who have reserve an aggregate of 14,784,001 shares of our common stock for future issuance. In addition, we have agreed to issue the BioCapital Warrant and the Placement Agent Warrants and to grant stock options to certain of our officers as described under “Management—Employment Agreements.” To the extent the preferred stock is converted or warrants or stock options are exercised, existing common stockholders would experience additional dilution which may cause the price of our common stock to decline.
We do not have a class of our securities registered under Section 12 of the Exchange Act. Until we do or we become subject to Section 15(d) of the Exchange Act, we will be a “voluntary filer.”
We are not currently required under Section 13 or Section 15(d) of the Exchange Act to file periodic reports with the SEC. We have in the past voluntarily elected to file some or all of these reports to ensure that sufficient information about us and our operations is publicly available to our stockholders and potential investors. Until we become subject to the reporting rules under the Exchange Act, we are not required to file annual, quarterly or current reports and could cease doing so at any time. Additionally, until we register a class of our securities under Section 12 of the Exchange Act, we are not subject to the SEC’s proxy rules, and large holders of our capital stock will not be subject to beneficial ownership reporting requirements under Sections 13 or 16 of the Exchange Act and their related rules. As a result, our stockholders and potential investors may not have available to them as much or as robust information as they may have if and when we become subjectpreferential rights superior to those requirements.
-16-
We do not expect to pay cash dividends inreceiving the foreseeable future on our common stock.
distribution.

We have not historically paid cashdeclared any dividends on our common stock, and we do not plan to pay cashdeclare any dividends on our common stock in the foreseeable future.

Item 1B.             

Unresolved Staff Comments.
None.
Item 2.                  Properties.
We currently lease a mailbox address and shared office space in Glen Allen, Virginia. Our lease expires in March 2017. Almost all of our business is conducted virtually. We believe that this arrangement is adequate to meet our current needs. If additional or alternative space is needed in the future, we believe such space will be available on commercially reasonable terms as necessary.
Item 3.                  Legal Proceedings.
On January 20, 2017, Robert F. Parker (the “petitioner”) filed a petition in the Supreme Court of the State of New York, County of New York, naming, among others, the Company and Ezra Green, a former shareholder, director and officer of the Company, as respondents. The petition was received by the Company on February 7, 2017. The petitioner previously had a judgment entered in his favor and against Clear Skies Solar, Inc. and its wholly owned subsidiary Clear Skies Group, Inc. (together, “Clear Skies”), in the amount of $331,132.45, with interest accruing at a rate of 9% per year from November 21, 2014 (the “Judgment”). The Judgment remains outstanding. The petition alleges, among other things, that through a series of allegedly fraudulent conveyances occurring before the Judgment was entered against Clear Skies, the major assets of Clear Skies, which were comprised of various patents, were transferred from Clear Skies to Carbon 612 Corporation (“Carbon”), and from Clear Skies and Carbon to the Company. The petition further alleges, among other things, that the transfers were without fair consideration and rendered Clear Skies, the judgment-debtor, insolvent. The petitioner seeks the entry of a judgment against the Company and the other respondents in the amount of the outstanding Judgment, with all accrued interest, reasonable attorneys’ fees and costs and disbursements. We believe the claims against the Company are without merit, and we intend to contest petitioner’s claims and defend the matter vigorously. Given the uncertainty of litigation, the preliminary stage of the case, and the legal standards that must be met for, among other things, success on the merits, we cannot estimate the reasonably possible loss or range of loss that may result from this action.
Item 4.                   Mine Safety Disclosures.
Not applicable.
-17-
PART II
Item 5.                    Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchasers ofEquity Securities.
Market Information
In 2015, our common stock was quoted on the Over-The-Counter QB Venture Marketplace (OTCQB) under the symbol “SGYT” and was not listed on any exchange. In 2016, our common stock is quoted on the Over-The-Counter QB Venture Marketplace (OTCQB) under the symbol “EXDI” and6. Selected Financial Data

A smaller reporting company is not listed on any exchange. The following table sets forthrequired to provide the range of high and low bid prices as reported for each period indicated. 

 
 
High
 
 
Low
 
Fiscal year ended December 31, 2015
 
 
 
 
 
 
 
 
 
 
 
 
 
March 31, 2015
  N/A 
  N/A 
June 30, 2015
  N/A 
  N/A 
September 30, 2015
  N/A 
  N/A 
December 31, 2015
 $2.00 
 $1.50 
 
 
High
 
 
Low
 
Fiscal year ended December 31, 2016
 
 
 
 
 
 
 
 
 
 
 
 
 
March 31, 2016
 $3.05 
 $3.00 
June 30, 2016
  3.05 
  0.55 
September 30, 2016
  2.50 
  0.56 
December 31, 2016
  1.50 
  0.40 
The foregoing quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission, and may not represent actual transactions. 
Holders
As of March 12, 2017, the Company had 47 common stock holders of record. In addition, as of such date, there were 7 holders of record of our Series B-1 preferred stock, 21 holders of our Series B-2 preferred stock, and one holder of our Series C preferred stock, convertible into an aggregate of 13,217,334 shares of our common stock based on conversion ratio equal to one common share for each share of preferred stock.
Dividends
We have never paid cash dividends on our capital stock. There are no restrictions that would limit us from paying dividends; however, we do not anticipate paying any cash dividends for the foreseeable future.
Securities Authorized for Issuance under Equity Compensation Plans
None
Item 6.                      Selected Financial Data.
Not applicable.
information required by this Item.

Item 7. Management’s DiscussionDiscussion and Analysis of Financial Condition and Results of Operations.

Operations Forward-Looking Statements

The following discussion and analysis of our financial condition and results of operations contains information that management believes is relevant to an assessment and understanding of our results of operations. You should be read this discussion in conjunction with theConsolidated Financial Statements unaudited condensed consolidated financial statements and the notes to those statements that are included elsewhere in this report. Our discussion includes forward-looking statements based upon current expectations that involve risks and uncertainties, such as our plans, objectives, expectations and intentions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements because of several factors, including those set forth under the Part I, Item 1A, Risk Factors and Business sections in our 2021 10-K, this report,. References and our other filings with the Securities and Exchange Commission. We use words such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and similar expressions to “Exactus,” the “Company,” “we,” “us” and “our”identify forward-looking statements. In addition, any statements that refer to Exactus, Inc.projections of our future financial performance, our anticipated growth and its subsidiary unless the context otherwise requires.

-18-
Cautionary Language Regarding Forward-Looking Statements
Certain statements set forth in this report constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements regarding future events and financial results, including our ability to complete development of the FibriLyzer, future clinical trials and regulatory approvals, and liquidity, as well as other statements that are not historical facts,or circumstances are forward-looking statements. These forward-looking statements are generally identified by such words or phrases as “we expect,” “we believe,” “would be,” “will allow,” “expects to,” “will continue,” “is anticipated,” “estimate,” “project” or similar expressions. While we provide forward-looking statements to assist in the understanding of our anticipated future financial performance, we caution readers not to place undue reliance on any forward-looking statements, which speak only as of the date that we make them. Forward-lookingSuch statements are based on our current expectations and assumptions thatcould be affected by the uncertainties and risk factors described throughout this report.

16

General

We are subjecta Nevada corporation organized in 2008. Exactus, Inc. was our former name. We have pursued opportunities in hemp-based businesses, which we refer to significant risksas “cannabinoids or CBD”. On June 30, 2021 Panacea Life Sciences, Inc. “Panacea” entered into an Exchange Agreement with Exactus and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Except as otherwise required by law, we undertake no obligation to publicly release any updates to forward-looking statements to reflect events after the datea result became a seed-to-sale Cannabinoid company. The former Panacea stockholders have assumed majority control of this yearly report on Form 10-K, including unforeseen events.

Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors that could have a material adverse effect onus and all our operations are now operated through Panacea which because of the share exchange became our wholly owned subsidiary. Leslie Buttorff, became our Chief Executive Officer and resultsa director upon the closing of the share exchange, also became our business include, but are not limited to:
● 
our history of operating lossesprincipal stockholder through common stock and lack of revenuesConvertible Preferred Stock issued to date;
● 
our limited cash resourcesher and our abilityentities she controls.

Panacea Life Sciences Holdings, Inc. (PLSH) is holding company structured to obtain additional funding necessary to develop our products and maintain liquidity;

● 
the success of our clinical trials through all phases of clinical development;
● 
the need to obtain regulatory approval of our products and any delays in regulatory reviews or product testing;
● 
market acceptance of, and our ability to commercialize, our products;
● 
competition from existing products or new products that may emerge;
● 
changes in technology;
● 
our dependence on the development and commercialization of our primary product, the FibriLyzer, to generate revenues in the future;
● 
our dependence on and our ability to maintain our licensing agreement;
● 
our ability and third parties’ abilities to protect intellectual property rights;
● 
potential product liability claims;
● 
our ability to maintain liquidity and adequately support future growth;
● 
changes in, and our ability to comply with, laws or regulations applicable to the life sciences and health and wellness industry. Panacea, which was founded by Leslie Buttorff in 2017 as a woman-owned business, attracted a $14 million investment from 22nd Century Group, Inc., or healthcare industries;
● 
our abilityXXII, a plant biotechnology company which also has a focus on CBD products and technology, during 2019. XXII has retained a 15.19% stake in us following the share exchange. Through Panacea, we are dedicated to attractdeveloping and retain key personnel to manage our business effectively;producing the highest-quality, most medically relevant, legal, hemp-derived cannabinoid products for consumers and
● 
other risks pets. Beginning at a farm Panacea owns a parcel of located at Needle Rock, Colorado and uncertainties described from time to time,leases laboratory space located within a 51,000 square foot, state-of-the-art, cGMP, extraction, manufacturing, testing and fulfillment center located in our filings made with the SEC.
General
On February 29, 2016, the Company consummated a share exchange, which resultedGolden, Colorado, Panacea operates in a change in controlevery segment of the Company. As partCBD product value chain. From cultivation to finished goods, Panacea ensures its products with stringent testing protocols employed at every stage of this transaction, the Company acquired Exactus BioSolutionssupply chain. Panacea endeavors to offer pure natural remedies within product lines for every aspect of life: PANA Life®, PANA Beauty®, PANA Sport™, PANA Pet®, PANA PURE™ and PANA Health™.

Its subsidiary, Panacea Life Sciences, Inc. (PLS) is dedicated to manufacturing, research and producing the highest-quality, hemp-derived cannabinoid, functional mushroom, Kratom and nutraceutical products for consumers and pets. From cultivation to finished goods, the company ensures its Licensing Agreementproducts with Digital Diagnosticsstringent GMP standards and testing protocols employed at every stage of the supply chain.

We are well positioned to develop producenovel hemp extracts as dietary supplements and commercialize blood diagnostic products that utilize certain intellectual property rights owned or licensed by Digital Diagnostics. The Licensing Agreement provides for Exactus BioSolutions and Digital Diagnostics to collaborate through the various stepstopical applications. Our biotechnology plans focus on our research at Colorado State University where we are involved in several health-related research studies.

Results of Operations

Comparison of the productYears Ended December 31, 2022, and device development process, including2021.

The following table sets forth our results of operations for the development, regulatory approvalyears ended December 31, 2022, and commercialization stages.

As a result of this transaction, Exactus became a life science company that plans to developDecember 31, 2021.

  Years Ended December 31,  Period to 
  2022  2021  Period Change 
          
Revenues from cannabinoid sales $1,515,448  $1,933,627  $(418,179)
Revenues from PPE sales $111,530  $66,000   45,530 
Cost of sales $1,230,508  $1,519,049  $(288,541)
Operating expenses $4,955,348  $4,959,059  $(3,710)
General and administrative $1,093,364  $1,518,687  $(425,322)
Interest expense $(2,048,171) $(1,105,243) $(942,928)
Unrealized gain on marketable securities $(2,660,105) $1,008,046  $(3,668,151)
Realized gain on sale of securities $22,816  $160,296  $(137,480)
Other income (loss) $27,598  $-  $27,598 
Employer retention credit $253,791  $396,679  $(142,888)
Rental income $232,183  $236,560  $(4,377)
Loss on sale of assets $-  $(297,351) $297,351 
Gain on extinguishment of debt $681,546  $755,782  $(74,236)

Year Ended December 31, 2022 and commercialize pursuant to the Licensing Agreement Point-of-Care (“POC”) diagnostics for measuring proteolytic enzymes2021

Net Revenues

We are principally engaged in the blood based on a proprietary detection platform (the “New Business”). business of manufacturing, producing and selling products for nutraceutical companies and our own products made from industrial hemp. Revenue consists of sales of our five category of brand products, white label and contract manufacturing sales to other CBD companies, raw material sales (distillate and isolate), and tolling arrangements.

Our primary product, the FibriLyzer, will employ a disposable test “biosensor” strip combined with a portable and easy to use hand held detection unit that provides a result in less than 30 seconds. The initial markets we intend to pursue for the FibriLyzer are (i) the management of hyperfibrinolytic states associate with surgery and trauma, (ii) obstetrics, (iii) acute events such as myocardial infarction and ischemic stroke, (iv) pulmonary embolism and deep vein thrombosis and (v) chronic coronary disease management. We expect to follow up the FibriLyzer with similar technology, the MatriLyzer to detect collagenase levels in the blood for the detection of the recurrence of cancer. We intend to file to gain regulatory approval to sell our products in the United States, Canada and Europe.  Management intends to primarily focus on the development and commercialization of the FibriLyzer and related technology exclusively licensed pursuant to the Licensing Agreement.

-19-
Prior to our acquisition of Exactus BioSolutions on February 29, 2016, our primary business focus was on developing and commercializing drone technology (the “Former Business”). Because we have changed our primary business focus, we do not believe a comparison of the Company’s financial resultsrevenues for the year ended December 31, 20162022, decreased by $432,649, or 21%, to the Company’s financial results$1,626,978 as compared to $2,059,627 for the year ended December 31, 20152021. The decrease in sales is meaningful.
On June 30, 2016,in 2021 was due primarily to the decrease of CBD sales and the continued impact COVID and the economy has had on the CBD business. In 2022, we entered into a Master Services Agreement with Integrium, LLCcontinued to see many of our CBD customers go out of business, so this continued to impact our white label and PoC Capital, LLCcontract manufacturing contracts. We expect the decrease in sales activity to conduct clinical studies for us, including a clinical trial for the FibriLyzer that is scheduledcontinue due to begin in the second halflimited capital resources until we consummate additional financing.

Cost of 2017.

ResultsSales

Cost of Operations

Year Ended December 31, 2016 Compared to Year Ended December 31, 2015:
 
 
Year Ended
 
 
 
 
 
 
December 31,
 
 
 
 
 
 
2016
 
 
2015
 
 
change
 
Revenue
 $- 
 $- 
 $- 
Operating expenses
  1,601,486 
  389,282 
  1,212,204 
 
    
    
    
Net loss from operations
  (1,601,486)
  (389,282)
  (1,212,204)
Total other (loss) income
  (1,453)
  31,092 
  (32,545)
 
    
    
    
Loss from continuing operations
 $(1,602,939)
 $(358,190)
 $(1,244,749)
Operating expenses increased by $1,212,204, from $389,282sales for the year ended December 31, 20152022, correspondingly decreased by $288,541, or 19%, to $1,601,486$1,230,508 as compared to $1,519,049 for the year ended December 31, 2016.2021. The differencedecrease in cost of sales was due primarily is attributable to:to decrease in sales as well as the acquisitioneffect of Exactus and changeCOVID-19 on the materials supply chain. The primary components of cost of sales include the cost of manufacturing the CBD products. The decrease in business focuscosts corresponds to the medical devices, an increasedecrease in professional and compliance fees of approximately $192,600 resulting from the acquisition and patent expenses; an increase in R&D expense of approximately $292,000 due to new business focus; an increase general and administrationsales.

17

Operating Expenses

Operating expenses of approximately $650,000 resulting from hiring two full time staff in February 2016 and license fees for the New Business, and $95,000 for stock based compensation.

As a result of the foregoing, we generated a loss from operations of $1,601,486 for the year ended December 31, 20162021 decreased by $429,032, or 7%, to $6,048,712 as compared to an operating loss of $389,282$6,677,746 for the year ended December 31, 2015, a change of 1,212,204.
2021. The Company had other loss of $1,453decrease in operating expenses was primarily due to loss on disposala cut back in general and administrative expenses of equipment from the former business focus$425,322.

The decrease in general and administrative expenses of $429,032 or 7% to $1,093,364 for the year ended December 31, 2016,2022, as compared to other income of $31,092$1,518,686 for the year ended December 31, 2015. The2021, was primarily due to decreases in sales commissions, sales and marketing activities as well as decreases in professional fees such as legal fees and consulting services.

Within the total G&A category of expenses, sales and marketing expenses decreased from $0.378 million to $0.169 million for the 12 months ended December 31, 2022 when compared to the 12 months ended December 31, 2021.

Also, within the total G&A category of expenses, professional, legal, and consulting fees were $0.478 million for the 12 months ended December 31, 2022, when compared to $0.779 million the 12 months ended December 31, 2021. In 2021, legal fees were related to the XXII farm sale and investment restructuring, the Panacea reverse merger and fees related to obtaining a trademark for our brand.

Other income in 2015 was $41,307 in debt forgiveness offset by $10,215 impairment of marketable securities.

 As a result of the foregoing, we generated a net loss from continuing operations of $1,602,939(expense)

Other income for the year ended December 31, 20162022, decreased by $4,645,111, or 402%, to (3,490,432) as compared to a net loss from continuing operations of $358,190$1,154,769 for the year ended December 31, 2015,2021. This decrease is due primarily to increased interest expense and a changedecrease in value of $1,244,749. the shares of XXII held by the company. In January, 2022 the XXII was trading at $2.17 verses $0.92 at year end.

Summary of Cash Flows

  Years ended December 31, 
  2021  2020 
Cash (used in) / provided by        
Operating activities $(2,399,579) $(3,922,090)
Investing activities  (196,972)  522,533 
Financing activities  2,583,728   3,334,953 
Net decrease in cash and cash equivalents $(12,823) $(64,605)

Cash flows from operating activities

Net loss for year period ended December 31, 2016cash used in operating activities was $1,602,939 compared to $357,977$2,399,579 for the year ended December 31, 2015 which included $213 revenue from discontinued operations.

-20-
Liquidity and Capital Resources
Since our inception in 2008, we have generated losses from operations. As of December 31, 2016, our accumulated deficit was $2,339,898 of which $736,959 was related2022, as compared to the Former Business.  Our net loss for the years ended December 31, 2016 and 2015 was $1,602,939 and $357,977, respectively.
Net cash used in operating activities$3,922,090 for the year ended December 31, 20162021. The decrease in 2022 was $890,956. We recorded adue primarily to decreasing operating and SG&A expenses. The largest source of operating cash is from our customers. Approximately one-half of our revenue comes from customers who purchase CBD on-line, so credit card payments are collected and paid within 1-2 business days. Other white label and contract manufacturing customers pay before the products are released in most cases. Some larger customers have either net loss for the year of $1,602,939. Other items in uses of funds10, 2% or 30 day net terms.

Cash flows from operations included non-cash charges related stock compensation for $100,000 and charges for bad debt, loss on disposal of equipment, and equipment impairment, which collectively totaled $12,543. Increases in accounts payable and accrued liabilities increased net cash from operatinginvesting activities by $547,941.

Net cash used in operatinginvesting activities was $196,972 for the year ended December 31, 2015 was $640,020. We recorded a2022, as compared to net loss of $357,977 for the period. Other items in uses of funds from operations included expenses incurred on behalf of parent company of $358,807 slightly offset by $68,885 expenses paid by related company.Changes in assets and liabilities totaled a gain of $10,015, which primarily consisted of an increase in restricted cash of $72,342 and increase in account payable of $84,748. 

Net cash provided by investing activities of $522,533 for the year ended December 31, 2016 was $1,292 due to the acquisition2021. The decrease of Exactus BioSolutions. Net cash provided by investing activity forin 2022 was due primarily to proceeds from sales of fixed assets and marketable securities.

Cash flows from financing activities

During the year ended December 31, 2015 was $0.

Net2022, cash provided by financing activities fortotaled $2,583,728 which includes proceeds of $4,090,448 from related party notes and $253,791 from a related party payroll protection loan partially offset by repayments of convertible notes of $1,100,000 and repayment of related party notes payable in the amount of $660,511. In 2022 the primary financing was cash provided by Company’s CEO.

During the year ended December 31, 2016 was $1,945,000 largely due to proceeds from our issuance of shares of Series B-2 Preferred Stock and offset by our payment for Series A Preferred Stock.  Net2021, cash provided by financing activities totaled $3,334,953 which includes of $2,302,468 from related party notes payable, $1,000,000 from convertible notes, and $243,041 from other loans.

Liquidity and Capital Resources

On December 31, 2022, we had approximately $1.1 million of liquid marketable securities and $7 thousand in cash. Our Chief Executive Officer holds the XXII shares pursuant to the pledge agreement and has the power at any time to permit us to sell the shares to provide working capital. We have borrowed substantial sums from Leslie Buttorff, our Chief Executive Officer, to meet its working capital obligations. On June 30, 2021, Panacea issued an affiliate of Ms. Buttorff a 12% demand promissory note for $4.063 million and issued Ms. Buttorff a 10% demand promissory note for $1.624 million secured by a pledge of certain XXII common stock owned by Panacea. Additionally, we have a line of credit with Ms. Buttorff through which it may borrow up to $5 million at a 10% annual interest rate.

18

We may not have sufficient cash resources to sustain our operations for the year ended December 31, 2015 was $598,328 due to $497,156next 12 months, particularly if the large sales contracts we have do not result in proceeds from a related party and $100,000 in proceeds from the issuance of a note payable.

As of December 31, 2016, we had $1,055,336 of cash. While we expect the existing cash will fund operations through Q4 2017, these funds will not be sufficient to enable us to complete the development of any potential products, including the FibriLyzer and related technology. Accordingly, we will need to obtain further funding through public or private equity offerings, debt financing, collaboration arrangements or other sources. The issuance of any additional shares of common stock, preferred stock or convertible securities could be substantially dilutive to our shareholders. In addition, adequate additional funding may not be available to us on acceptable terms, or at all. If we are unable to raise capital, we will be forced to delay, reduce or eliminate our research and development programs and may not be able to continuerevenue anticipated. This raises substantial doubt as a going concern.
Going Concern
The audit report prepared by our independent registered public accounting firm relatingconcern as we are dependent on obtaining financing from one or more debt or equity offerings or further loans from Ms. Buttorff assuming she agrees to our financial statements for the year ended December 31, 2016 includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern.
Off-Balance Sheet Arrangements
As of December 31, 2016, we had no material off-balance sheet arrangements.
In the normal course of business, we may be confronted with issues or events that may result in a contingent liability. These generally relate to lawsuits, claims or the actions of various regulatory agencies. We consult with counsel and other appropriate experts to assess the claim. If, in our opinion, we have incurred a probable loss as set forth by accounting principles generally accepted in the United States, an estimate is made of the loss and the appropriate accounting entries are reflected in our financial statements. After consultation with legal counsel, we do not anticipate that liabilities arising out of currently pending or threatened lawsuits and claims will have a material adverse effect on our financial position, results of operations or cash flows.
-21-
Critical Accounting Estimates and New Accounting Pronouncements
Critical Accounting Estimates
The preparation of financial statements in accordance with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect reported amounts and related disclosures in the financial statements. Management considers an accounting estimate to be critical if it requires assumptions to be made that were uncertain at the time the estimate was made, and changes in the estimate or different estimates that could have been selected could have a material impact on our results of operations or financial condition.
Application of Significant Accounting Policies
Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits of this extended transition period. Our financial statements may, therefore, not be comparable to those of companies that comply with such new or revised accounting standards.
Recent Accounting Pronouncements
We have reviewed the FASB issued Accounting Standards Update (“ASU”) accounting pronouncements and interpretations thereof that have effectiveness dates during the periods reported and in future periods. The Company has carefully considered the new pronouncements that alter previous generally accepted accounting principles and does not believe that any new or modified principles will have a material impact on the corporation’s reported financial position or operations in the near term. The applicability of any standard is subject to the formal review of our financial management and certain standards are under consideration.
Item 7A.              Quantitative and Qualitative Disclosures About Market Risk.
Not applicable.
Item 8.                 Financial Statements and Supplementary Data.
CONTENTS
CONSOLIDATED FINANCIAL STATEMENTS
F-1
F-2
F-3
F-4
F-5
 F-6
-22-
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of
Exactus, Inc. (formerly known as Spiral Energy Tech, Inc.)
We have audited the accompanying consolidated balance sheets of Exactus, Inc. (formerly known as Spiral Energy Tech, Inc.) (the “Company”) as of December 31, 2016 and 2015, and the related consolidated statements of operations, stockholders’ equity (deficit) and cash flows for each of the two years in the period ended December 31, 2016. advance further funds.

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The company is not required to have, nor were we engaged to perform an audit of the Company’s internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of Exactus, Inc. (formerly known as Spiral Energy Tech, Inc.) at December 31, 2016 and 2015, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2016, in conformity with accounting principles generally accepted in the United States of America.
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company suffered a net loss, has accumulated deficit and has a net working capital deficiency, which raises substantial doubt about its ability to continue as a going concern. Management’s plans regarding those matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
/s/ RBSM LLP
March 31, 2017
New York, New York
F-1
Exactus, Inc.
(formerly known as Spiral Energy Tech, Inc.)
Consolidated Balance Sheets
 
 
December 31,
 
 
December 31,
 
 
 
2016
 
 
 2015
 
 
 
 
 
 
 
 
ASSETS
 
 
 
 
 
 
Current Assets
 
 
 
 
 
 
Cash and cash equivalents
 $1,055,336 
 $- 
Restricted cash
  - 
  72,342 
Due from related parties
  - 
  7,010 
Prepaid expenses
  1,019,721 
  - 
Total current assets
  2,075,057 
  79,352 
 
    
    
Property and equipment, net of accumulated depreciation of $0 and $1,914, respectively.
  - 
  1,453 
Intangible asset- license agreement
  50,000 
  - 
Intellectual property- patents, net
  - 
  4,080 
 
    
    
TOTAL ASSETS
 $2,125,057 
 $84,885 
 
    
    
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
    
    
 
    
    
Current Liabilities
    
    
Bank overdraft
 $- 
 $1,172 
Accounts payable
  566,495 
  75,483 
Accrued expenses
  58,479 
  1,550 
Note payable
  - 
  100,000 
Total Current Liabilities
  624,974 
  178,205 
 
    
    
TOTAL LIABILITIES
  624,974 
  178,205 
 
    
    
Commitments and contingencies (see note 9)
    
    
 
    
    
Stockholders' Equity (Deficit)
    
    
Preferred stock: 50,000,000 authorized; $0.0001 par value 0 shares issued and outstanding
  - 
  - 
Preferred stock Series A: 5,000,000 and 0 authorized; $0.0001 par value 4,558,042 and 0 shares issued, respectively and 0 shares outstanding
  - 
  - 
Preferred stock Series B-1: 32,000,000 and 0 authorized; $0.0001 par value 2,800,000 and 0 shares issued and outstanding, respectively
  280 
  - 
Preferred stock Series B-2: 10,000,000 and 0 authorized; $0.0001 par value 8,584,000 and 0 shares issued and outstanding, respectively
  858 
  - 
Preferred stock Series C: 1,733,334 and 0 authorized; $0.0001 par value 1,733,334 and 0 shares issued and outstanding, respectively
  173 
  - 
Common stock: 200,000,000 shares authorized; $0.0001 par value 34,071,862 and 515,290 shares issued and outstanding, respectively
  3,407 
  52 
Additional paid-in capital
  3,835,263 
  643,587 
Accumulated deficit
  (2,339,898)
  (736,959)
Total Stockholders' Equity (Deficit)
  1,500,083 
  (93,320)
 
    
    
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
 $2,125,057 
 $84,885 
 
    
    
 
The accompanying notes are an integral part of these consolidated financial statements.
 
F-2
Exactus, Inc.
(formerly known as Spiral Energy Tech, Inc.)
Consolidated Statements of Operations
 
 
Year Ended December 31,
 
 
 
2016
 
 
2015
 
 
 
 
 
 
 
 
Revenues
 $- 
 $- 
 
    
    
Operating Expenses
    
    
General and administration
  759,145 
  108,400 
Professional
  368,917 
  176,286 
Research and development
  369,344 
  77,344 
Impairment
  4,080 
  20,625 
Stock-based compensation
  100,000 
  5,000 
Depreciation and amortization
  - 
  1,627 
Total operating expenses
  1,601,486 
  389,282 
 
    
    
Net loss from operations
  (1,601,486)
  (389,282)
 
    
    
Other Income (loss)
    
    
 
    
    
Impairment on marketable securities
  - 
  (10,215)
Debt forgiveness
  - 
  41,307 
Loss on disposal of equipment
  (1,453)
  - 
Total other (loss) income
  (1,453)
  31,092 
 
    
    
Net loss before income taxes
  (1,602,939)
  (358,190)
Provision for income tax
  - 
  - 
 
    
    
Loss from continuing operations
 $(1,602,939)
 $(358,190)
 
    
    
Revenue from discontinued operations
  - 
  213 
 
    
    
Net Loss
 $(1,602,939)
 $(357,977)
 
    
    
Basic and Diluted Loss per Common Share
 $(0.08)
 $(0.70)
 
    
    
Weighted Average Number of Common Shares Outstanding
  19,220,686 
  512,003 
 
    
    
The accompanying notes are an integral part of these consolidated financial statements.     

F-3
Exactus, Inc.
(formerly known as Spiral Energy Tech, Inc.)
Consolidated Statements of Stockholders' Equity (Deficit)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Additional
 
 
Accumulated
 
 
 
 
 
 
 
 
 
Preferred Stock -
Series A
 
 
Preferred Stock-
Series B-1
 
 
Preferred Stock-
Series B-2
 
 
Preferred Stock-
Series C
 
 
Common Stock
 
 
Paid in
 
 
Other
Comprehensive
 
 
Accumulated
 
 
 
 
 
 
 Shares
 
 
 Amount
 
 
 Shares
 
 
 Amount
 
 
 Shares
 
 
 Amount
 
 
 Shares
 
 
 Amount
 
 
 Shares
 
 
 Amount
 
 
 Capital
 
 
  Income (Loss)
 
 
 Deficit
 
 
 Total
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance, December 31, 2014
  - 
 $- 
  - 
 $- 
  - 
 $- 
  - 
 $- 
  511,910 
 $51 
 $430,905 
 $(6,210)
 $(378,982)
 $45,764 
 
    
    
    
    
    
    
    
    
    
    
    
    
    
    
Stock issued to related party
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  3,380 
  1 
  4,999 
  - 
  - 
  5,000 
Capital Conribution
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  207,683 
  - 
  - 
  207,683 
Impairment of investment in marketable securities
    
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  6,210 
  - 
  6,210 
Net loss
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  (357,977)
  (357,977)
 
    
    
    
    
    
    
    
    
    
    
    
    
    
    
Balance, December 31, 2015
  - 
 $- 
  - 
 $- 
  - 
 $- 
  - 
 $- 
  515,290 
 $52 
 $643,587 
 $- 
 $(736,959)
 $(93,320)
 
    
    
    
    
    
    
    
    
    
    
    
    
    
    
Common Stock Exchanged for Preferred Stock Series A
  4,558,042 
  455 
  - 
  - 
  - 
  - 
  - 
  - 
  (393,314)
  (39)
  (416)
  - 
  - 
  - 
Preferred Series A Stock purchased and cancelled, February 29, 2016
  (50,000)
  (5)
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  (49,995)
  - 
  - 
  (50,000)
Preferred Series B-1 stock issued for acquisition of Excatus Bioslution, Inc., February 29, 2016
  - 
  - 
  30,000,000 
  3,000 
  - 
  - 
  - 
  - 
  - 
  - 
  (2,708)
  - 
  - 
  292 
Preferred Series B-2 stock issued for cash, note payable and liability, February 29, 2016
  - 
  - 
  - 
  - 
  2,084,000 
  208 
  - 
  - 
  - 
  - 
  520,792 
  - 
  - 
  521,000 
Preferred Series A conversion to common stock, March 28, 2016 and March 30, 2016
  (4,508,042)
  (450)
  - 
  - 
  - 
  - 
  - 
  - 
  4,508,042 
  450 
  - 
  - 
  - 
  - 
Preferred Series B-1 conversion to common stock, June 15, 2016
  - 
  - 
  (27,200,000)
  (2,720)
  - 
  - 
  - 
  - 
  27,200,000 
  2,720 
  - 
  - 
  - 
  - 
Common stock, Preferred Series C stock, and warrants issued for prepaid services, June 30, 2016
  - 
  - 
  - 
  - 
  - 
  - 
  1,733,334 
  173 
  1,600,000 
  160 
  999,667 
  - 
  - 
  1,000,000 
Preferred Series B-2 stock issued for cash, July 15, 2016
  - 
  - 
  - 
  - 
  500,000 
  50 
  - 
  - 
  - 
  - 
  124,950 
  - 
  - 
  125,000 
Preferred Series B-2 stock issued for cash, October 27, 2016
  - 
  - 
  - 
  - 
  6,000,000 
  600 
  - 
  - 
  - 
  - 
  1,499,400 
  - 
  - 
  1,500,000 
Common Stock issued, Share based Payment, November 11, 2016
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  141,844 
  14 
  99,986 
  - 
  - 
  100,000 
Common Stock Issued, Share based Payment, December 13, 2016
    
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  500,000 
  50 
  - 
  - 
  - 
  50 
Net Loss
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  - 
  (1,602,939)
  (1,602,939)
 
    
    
    
    
    
    
    
    
    
    
    
    
    
    
Balance, December 31, 2016
  - 
 $- 
  2,800,000 
 $280 
  8,584,000 
 $858 
  1,733,334 
 $173 
  34,071,862 
 $3,407 
 $3,835,263 
 $- 
 $(2,339,898)
 $1,500,083 
 
    
    
    
    
    
    
    
    
    
    
    
    
    
    
The accompanying notes are an integral part of these consolidated financial statements.                              
F-4
Exactus, Inc.
(formerly known as Spiral Energy Tech, Inc.)
Consolidated Statements of Cash Flows
 
 
Year Ended December 31,
 
 
 
 2016
 
 
 2015
 
 
 
 
 
 
 
 
Cash Flows From Operating Activities:
 
 
 
 
 
 
Net loss
 $(1,602,939)
 $(357,977)
Adjustments to reconcile net loss to cash used in operations:
    
    
Depreciation and amortization
  - 
  1,627 
Expenses incurred on behalf of parent company
  - 
  (358,807)
Expenses paid by related company
  - 
  68,885 
Bad debt
  7,010 
  1,704 
Debt forgiveness
  - 
  (41,307)
Loss on disposal of property and equipment
  1,453 
  - 
Impairment of equipment
  4,080 
  20,625 
Impairment of marketable securities
  - 
  10,215 
Stock-based compensation
  100,000 
  5,000 
Bank overdraft write-off
  (1,172)
  - 
Changes in operating assets and liabilities:
    
    
(Increase) decrease in operating assets:
    
    
Accounts receivable
  - 
  (213)
Due from related parties
  - 
  (895)
Prepaid expenses
  (19,671)
  4,167 
Restricted cash
  72,342 
  (72,342)
Increase (decrease) in operating liabilities:
  - 
  - 
Accounts payable
  491,012 
  84,748 
Accrued expenses
  56,929 
  (5,450)
Net Cash Used In Operating Activities
  (890,956)
  (640,020)
 
    
    
Cash Flows From Investing Activities:
    
    
Acquisition of cash balance from Exactus BioSolutions Inc.
  1,292 
  - 
Net Cash Provided by Investing Activities
  1,292 
  - 
 
    
    
Cash Flows From Financing Activities:
    
    
Proceeds from sale of Series B-2 Preferred Stock
  1,995,000 
  - 
Payment for Series A Preferred Stock
  (50,000)
  - 
Proceeds from related party (contributed capital)
  - 
  497,156 
Proceeds from issuance of note payable
  - 
  100,000 
Bank overdraft
  - 
  1,172 
Net Cash Provided By Financing Activities
  1,945,000 
  598,328 
 
    
    
Net increase (decrease) in cash and cash equivalents
  1,055,336 
  (41,692)
Cash and cash equivalents at beginning of period
  - 
  41,692 
 
    
    
Cash and cash equivalents at end of period
 $1,055,336 
 $- 
 
    
    
Supplemental Cash Flow Information:
    
    
Cash paid for interest
 $- 
 $- 
Cash paid for taxes
 $- 
 $- 
 
    
    
Non-Cash transactions:
    
    
Purchase of Patent by related party
 $- 
 $450 
Acquisition of license agreement from Exactus BioSolutions Inc
 $50,000 
 $- 
Preferred Stock Series B-2 issued as payment for Note payable
 $100,000 
 $- 
Preferred Stock Series B-2 issued as payment for Exactus shareholder loans
 $51,000 
 $- 
Preferred Stock Series C, common stock, and warrants issued as part of Master Service Agreement and Stock Subscription Agreement as prepaid expense
 $1,000,000 
 $- 
 
    
    
The accompanying notes are an integral part of these consolidated financial statements.
F-5
Exactus, Inc.
(formerly known as Spiral Energy Tech, Inc.)
Notes to the Audited Financial Statements
December 31, 2016 and 2015
NOTE 1. BUSINESS DESCRIPTION
 Exactus was incorporated on January 18, 2008 as “Solid Solar Energy, Inc.” in the State of Nevada as a for-profit Company. On May 16, 2013, we filed a certificate of amendment to the Company’s amended and restated articles of incorporation to change our name to “Spiral Energy Tech., Inc.” from Solid Solar Energy, Inc.  On February 29, 2016, we acquired all of the issued and outstanding capital stock of Exactus BioSolutions, Inc. (“Exactus BioSolutions”) pursuant to a Share Exchange Agreement, dated February 29, 2016, with Exactus BioSolutions (the “Share Exchange”). The Company issued 30 million shares of newly-designated Series B-1 Preferred Stock to the shareholders of Exactus BioSolutions in the Share Exchange, representing approximately 87% of voting control of the Company upon consummation of the Share Exchange. As a result of the Share Exchange, Exactus BioSolutions became a wholly-owned subsidiary of Exactus, Inc. Effective March 22, 2016, we changed our corporate name to “Exactus, Inc.” via a merger with our wholly-owned subsidiary, Exactus Acquisition Corp.   
Following the Share Exchange, we became a life science company that plans to develop and commercialize Point-of-Care (“POC”) diagnostics for measuring proteolytic enzymes in the blood based on a proprietary detection platform (the “New Business”). Our primary product, the FibriLyzer, will employ a disposable test “biosensor” strip combined with a portable and easy to use hand held detection unit that provides a result in less than 30 seconds.  The initial markets we intend to pursue for the FibriLyzer are (i) the management of hyperfibrinolytic states associate with surgery and trauma, (ii) obstetrics, (iii) acute events such as myocardial infarction and ischemic stroke, (iv) pulmonary embolism and deep vein thrombosis and (v) chronic coronary disease management. We expect to follow up the FibriLyzer with similar technology, the MatriLyzer, to detect collagenase levels in the blood for the detection of the recurrence of cancer. We intend to file to gain regulatory approval to sell our products in the United States, Canada and Europe.  Management intends to primarily focus on the development and commercialization of the FibriLyzer and related technology exclusively licensed by Exactus.  
Prior to our acquisition of Exactus BioSolutions pursuant to the Share Exchange, our primary business focus was on developing and commercializing drone technology (the “Former Business”).
NOTE 2. GOING CONCERN
These financial statements are presented on the basis that we will continue as a going concern. The going concern concept contemplates the realization of assets and satisfaction of liabilities in the normal course of business. No adjustment has been made to the carrying amount and classification of our assets and the carrying amount of our liabilities based on the going concern uncertainty. We have considered ASU 2014-15 in consideration of reporting requirements of theThese factors raise substantial doubt about our ability to continue as a going concern financial statements.
Since our inception in 2008, we have generated lossesfor a period of 12 months from operations and we anticipatethe issuance date of this report. Management cannot provide assurance that we will continueultimately achieve profitable operations or become cash flow positive or raise additional debt and/or equity capital. In addition, due to generate significant losses from operations for the foreseeable future. As of December 31, 2016, our accumulated deficit was $2,339,898 of which $736,959 was related to the Former Business.  As of December 31, 2016, we had $1,055,336 of cash. We expect that these funds will not be sufficient to enable us to complete the development of any potential products, including the FibriLyzer and related technology. Accordingly,insufficient revenue, we will need to obtain further funding through public or private equity offerings, debt financing, collaboration arrangements or other sources in order to maintain active business operations. We currently do not have sufficient cash flow to pay our ongoing financial obligations on a consistent basis. The issuance of any additional shares of common stock, preferred stock or convertible securities could be substantially dilutive to our stockholders. In addition, adequate additional funding may not be available to us on acceptable terms, or at all. If we are unable to raise capital, we will be forced to borrow additional sums from our Chief Executive Officer or delay, reduce or eliminate our research and development programs, we may not be able to continue as a going concern, and we may be forced to discontinue operations. These consolidated financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.

Off Balance Sheet Arrangements

As of December 31, 2022, we had no material off-balance sheet arrangements.

Critical Accounting Estimates and New Accounting Pronouncements

Critical Accounting Estimates

The discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with US GAAP. The preparation of our consolidated financial statements requires its management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses and related disclosures. Our management bases its estimates, assumptions and judgments on historical experience and various other factors that are believed 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. Different assumptions and judgments would change the estimates used in the preparation of our consolidated financial statements which, in turn, could change the results from those reported. In addition, actual results may differ from these estimates and such differences could be material to our financial position and results of operations.

Critical accounting estimates are those that our management considers the most important to the portrayal of our financial condition and results of operations because they require management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Our critical accounting estimates in relation to its consolidated financial statements include those related to:

Goodwill and intangible assets
Fair value of marketable securities
Incremental Borrowing Rate used Right of Use Asset Calculations
Business combinations

Goodwill and Indefinite-Lived Intangibles

We allocate the cost of acquired companies to the identifiable tangible and intangible assets acquired and liabilities assumed, with the remaining amount classified as goodwill. The identification and valuation of these intangible assets and the determination of the estimated useful lives at the time of acquisition, as well as the completion of impairment tests, require significant management judgments and estimates. These estimates are made based on, among other factors, review of projected future operating results and business plans, economic projections, anticipated highest and best use of future cash flows and the cost of capital. The use of alternative estimates and assumptions could increase or decrease the estimated fair value of goodwill and other intangible assets, and potentially result in a different impact to our results of operations. Further, changes in business strategy and/or market conditions may significantly impact these judgments and thereby impact the fair value of these assets, which could result in an impairment of the goodwill or intangible assets.

Goodwill is not amortized but is tested for impairment annually and whenever events or circumstances change that indicate impairment may have occurred. We tested goodwill for impairment and determined there was no impairment and found not impairment charge based on the excess of a reporting unit’s carrying amount over our fair value.

Fair value of marketable securities

Marketable securities are recorded at fair value using the quoted market prices and changes in fair value are recorded as net realized gains or losses in comprehensive income. We monitor these investments for impairment and make appropriate reductions in carrying values as necessary.

19

Incremental Borrowing Rate used Right of Use Asset Calculations

We determine if a contract is a lease or contains a lease at the inception of the contract and reassess that conclusion if the contract is modified. All leases are assessed for classification as an operating lease or a finance lease. Operating lease right-of-use, or ROU, assets are included in non-current other assets on our consolidated balance sheet. Operating lease liabilities are separated into a current portion, included within other accrued liabilities on our consolidated balance sheet, and a non-current portion, included within other long-term liabilities on our consolidated balance sheet. We do not have any finance lease ROU assets or liabilities. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. We do not obtain and control the right to use the identified asset until the lease commencement date.

Our lease liabilities are recognized at the applicable lease commencement date based on the present value of the lease payments required to be paid over the lease term. Because the interest rate implicit in the lease is not readily determinable, we generally use our incremental borrowing rate to discount the lease payments to present value. The estimated incremental borrowing rate is derived from information available at the lease commencement date. We factor in publicly available data for instruments with similar characteristics when calculating our incremental borrowing rates. Our ROU assets are also recognized at the applicable lease commencement date. The ROU asset equals the carrying amount of the related lease liability, adjusted for any lease payments made prior to lease commencement and lease incentives provided by the lessor. Variable lease payments are expensed as incurred and do not factor into the measurement of the applicable ROU asset or lease liability.

Business Combinations

We have applied significant estimates and judgments in order to determine the fair value of the identified assets acquired, liabilities assumed and goodwill recognized in connection with our business combinations to ensure the value of the assets and liabilities acquired are recognized at fair value as of the acquisition date. In measuring the fair value, we utilize valuation techniques consistent with the market approach, income approach, or cost approach.

The valuation of the identifiable assets and liabilities includes assumptions made in performing the valuation, such as projected revenue, weighted average cost of capital, discount rates, estimated useful lives, and other relevant assessments. These assessments can be significantly affected by our estimates, judgments, and assumptions. If actual results are not consistent with our estimates, judgments, or assumptions, or if additional or new information arises in the future that affects our fair value estimates, then adjustments to our initial fair value estimates may have a material impact to our purchase accounting or our results of operations. If actual results are not consistent with our estimates, judgments, or assumptions, or if additional or new information arises in the future, beyond our one-year measurement period, that affects our fair value estimates, then adjustments to our initial fair value estimates may have a material impact to our results of operations

Item 7A. Quantitative and Qualitative Disclosures about Market Risk

A smaller reporting company is not required to provide the information required by this item.

20

Item 8. Financial Statements and Supplementary Data

Index to Financial Statements Required by Article 8 of Regulation S-X:

Audited Financial Statements:

CONTENTS
CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firms (PCAOB ID: 5041)F-2
Consolidated Balance Sheets as of December 31, 2022 and 2021F-3
Consolidated Statements of Operations for the years ended December 31, 2022 and 2021F-4
Consolidated Statements of Stockholders’ Equity (Deficit) for the years ended December 31, 2022 and 2021F-5
Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021F-6
Notes to the Consolidated Financial StatementsF-7

F-1

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Shareholders of Panacea Life Sciences Holdings, Inc.:

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Panacea Life Sciences Holdings, Inc. (the “Company”) as of December 31, 2022 and 2021 and the related consolidated statements of operations, shareholders’ equity, and cash flows for the two years in the period ended December 31, 2022, and the related notes and schedules (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the two years in the period ended December 31, 2022 and 2021, in conformity with accounting principles generally accepted in the United States of America.

Going Concern Matter

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has suffered recurring losses from operations that raises substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

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

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

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

Critical Audit Matter

Critical audit matters are matters arising from the current-period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.

We determined that there are no critical audit matters.

/S/ BF Borgers CPA PC (PCAOB ID 5041)
We have served as the Company’s auditor since 2021
Lakewood, CO
March 29, 2023


F-2

Panacea Life Sciences Holdings, Inc. and Subsidiary

Consolidated Balance Sheets

  December 31, 2022  December 31, 2021 
ASSETS        
CURRENT ASSETS:        
Cash and cash equivalents $6,951  $19,774 
Accounts receivable, net  206,127   244,496 
Other receivables, related party  500,000   500,000 
Inventory  4,448,725   4,264,277 
Marketable securities related party  1,107,362   3,791,483 
Prepaid expenses and other current assets  113,098   278,328 
TOTAL CURRENT ASSETS  6,382,263   9,098,358 
         
Operating lease right-of-use asset, net, related party  3,242,381   3,595,100 
Property and equipment, net  7,675,995   8,839,982 
Intangible assets, net  -   61,401 
Goodwill  2,188,810   2,188,810 
TOTAL ASSETS $19,489,449  $23,783,651 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
CURRENT LIABILITIES:        
Accounts payable and accrued expenses $2,666,076  $1,685,825 
Operating lease liability, current portion, related party  2,090,271   1,624,090 
Note payable-current, related party  9,871,803   6,441,866 
Convertible note payable, net  346,671   220,005 
Paycheck protection loan, SBA Loan  99,100   99,100 
TOTAL CURRENT LIABILITIES:  15,073,921   10,070,886 
         
Operating lease liability, long-term portion, related party  2,987,208   3,347,335 
Other long-term liabilities, related party  3,572,864   3,263,028 
TOTAL LIABILITIES  21,633,993   16,681,249 
         
Commitments and contingencies  -   - 
         
STOCKHOLDERS’ EQUITY        
Series A Preferred Stock: $0.0001 Par Value, 1,000 shares designated; 0 and 350 shares issued and outstanding on December 31, 2022 and December 31, 2021 respectively.  -   - 
Series B-1 Preferred: $0.0001 Par Value, 32,000,000 shares designated; 1,500,000 and 1,500,000 shares issued and outstanding on December 31, 2022 and December 31, 2021 respectively.  150   150 
Series B-2 Preferred: $0.0001 Par Value, 6,000,000 shares designated; 6,000,000 and 6,000,000 shares issued and outstanding on December 31, 2022 and December 31, 2021 respectively.  600   600 
Series C Preferred: $0.0001 Par Value, 1,000,000 shares designated; 1,000,000 and 1,000,000 shares issued and outstanding on December 31, 2022 and December 31, 2021 respectively.  100   100 
Series C-1 Preferred: $0.0001 Par Value, 10,000 shares designated and 10,000 and 10,000 shares issued and outstanding on December 31, 2022 and December 31, 2021 respectively.  1   1 
Series C-2 Preferred: $0.0001 Par Value, 100 and 0 shares designated and 100 and 0 shares issued and outstanding on December 31, 2022 and December 31, 2021 respectively.  -   1 
Series D Preferred: $0.0001 Par Value, 10,000 shares designated and 10,000 and 10,000 shares issued and outstanding on December 31, 2022 and December 31, 2021 respectively.  1   1 
Preferred Stock, Value      
Common Stock: $0.0001 Par Value, 650,000,000 shares authorized; 14,965,317 and 14,073,708 shares issued and outstanding on December 31, 2022 and December 31, 2021 respectively.  1,497   1,407 
Additional paid in capital  23,760,704   23,865,155 
Accumulated deficit  (25,907,597)  (16,765,013)
TOTAL STOCKHOLDERS’ EQUITY  (2,144,544)  7,102,402 
         
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $19,489,449  $23,783,651 

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

F-3

Panacea Life Sciences Holdings, Inc. and Subsidiary

Consolidated Statements of Operations

  2022  2021 
  For the year ending December 31, 
  2022  2021 
       
REVENUE $1,626,978  $2,059,627 
COST OF SALES  1,230,508   1,519,049 
GROSS PROFIT  396,470   540,578 
         
OPERATING EXPENSES        
Production related operating expenses  4,955,348   4,959,059 
General and administrative expenses  1,093,364   1,518,687 
TOTAL OPERATING EXPENSES  6,048,712   6,477,746 
         
LOSS FROM OPERATIONS  (5,652,242)  (5,937,168)
         
OTHER INCOME (EXPENSES)        
Interest expense  (2,048,171)  (1,105,243)
Unrealized gain (loss) on marketable securities, net  (2,660,105)  1,008,046 
Realized gain on sale of securities  22,816   160,296 
Other income (loss)  27,598   - 
Employer retention credit  253,791   396,679 
Rental Income  232,183   236,560 
Loss on sale of assets  -   (297,351)
Gain on extinguishment of debt  681,546   755,782 
TOTAL OTHER INCOME (EXPENSE)  (3,490,342)  1,154,769 
         
INCOME (LOSS) BEFORE INCOME TAXES  (9,142,584)  (4,782,399)
         
TAXES  -   - 
         
NET INCOME (LOSS) $(9,142,584) $(4,782,399)
         
Per-share data        
Basic and diluted loss per share $(0.62) $(0.28)
         
Weighted average number of common shares outstanding  14,862,077   16,915,706 

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

F-4

Panacea Life Sciences, Inc.

Statements of Stockholders’ Equity

  Shares  Amount  Shares  Amount  Capital  Deficit  Equity 
  Preferred Stock  Common Stock  Additional Paid-in  Accumulated  Total Stockholder’s 
  Shares  Amount  Shares  Amount  Capital  Deficit  Equity 
                      
Balance as of December 31, 2021  8,530,350  $853   14,073,708  $1,407  $23,865,155  $(16,765,013) $7,102,402 
                             
Shares issued in respect of the merger  -   -   834,331   83   (83)  -   - 
Issuance of common shares for services          57,278   6   54,994       55,000 
Conversion of Series A Preferred to convertible debt and warrants  (350)              (159,362)      (159,362)
Net Loss  -  -   -  -   -  (9,142,584) (9,142,584)
Balance as of December 31, 2022  8,530,000  $853   14,965,317  $1,497  $23,760,704  $(25,907,597) $(2,144,544)

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

F-5

Panacea Life Sciences, Inc.

Statements of Cash Flows

  2022  2021 
  For the years ended December 31 
  2022  2021 
Cash flows from operating activities        
Net income (loss) $(9,142,584) $(4,782,399)
Adjustments to reconcile net loss to net cash used in operating activities        
Depreciation  1,669,690   1,675,786 
Realized gain on sale of securities  (22,816)  (160,296)
Unrealized (gain)/loss on marketable securities  2,660,105   (1,008,046)
Fixed Asset Disposal Loss  -   297,351 
Non cash settlement of convertible note and accrued interest  (253,791)  (755,782)
Amortization of intangible assets  61,401   61,400 
Amortization of debt discount and non-cash interest expense  1,067,304   117,515 
Changes in operating assets and liabilities        
Accounts receivable  38,369   (97,194)
Inventory  (184,448)  (547,910)
Prepaid expense and other assets  165,230   (250,953)
Accounts payable and accrued expenses  1,083,188   1,069,668 
Operating lease liability, net  458,773   458,770 
Net cash used in operating activities  (2,399,579)  (3,922,090)
         
Cash flows from investing activities        
Net cash received from acquisition  -   9,157 
Proceeds from sale of marketable securities  46,832   230,296 
Proceeds from sale of fixed assets  -   446,026 
Net fixed asset acquisitions  (243,804)  (162,946)
Net Cash provided by (used in) investing activities  (196,972)  522,533 
         
Cash flows from financing activities        
Repayment of notes payable  (1,100,000)  (75,556)
Proceeds from payroll protection loan, SBA loan  253,791   243,041 
Payments of principal on notes payable  (660,511)  (135,000)
Proceeds from Notes payable - related party  4,090,448   2,302,468 
Proceeds from issuance of convertible notes, net of discount  -   1,000,000 
Cash provided by financing activities  2,583,728   3,334,953 
         
Net increase (decrease) in Cash and Cash Equivalents  (12,823)  (64,605)
Cash and Cash Equivalents, Beginning of Period  19,774   84,379 
Cash and Cash Equivalents, End of Period $6,951  $19,774 
         
Supplemental Disclosure of Cash Flow Information        
Cash paid for income taxes during the year $-  $- 
Interest payments during the year $-  $- 
         
Noncash investing and financing activity        
Non-cash Receivable - related party $-  $500,000 
Related party loan repayment with inventory $-  $4,693,367 
Non-cash fixed asset disposal as part of the reverse acquisition $-  $3,058,457 
Conversion of Preferred A shares to Note Payable $385,000  $- 
Issuance of Common Stock for services $55,000  $- 
Capitalized assets purchased on account - related party $261,899  $564,369 
Liabilities from acquisition $-  $1,096,782 
Debt retired in merger, related party $-  $12,718,441 
Preferred Series B-1 Issuance in Acquisition $-  $150 
Preferred Series B-2 Issuance in Acquisition $-  $600 
Common stock issued for the reverse merger with Exactus $-  $4,369,085 
Discounts related to issuance of convertible debt and warrants $-  $997,510 

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

F-6

PANACEA LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

DECEMBER 31, 2022

NOTE 1 - NATURE OF ORGANIZATION

Organization and Business Description

Panacea Life Sciences Holdings, Inc. (the “Company”, “Panacea Holdings”, “Exactus”, “we”, “us”, “our”) was incorporated on January 18, 2008, in the State of Nevada. In January 2019, the Company added to the scope of its business activities, efforts to produce, market and sell products made from industrial hemp containing cannabidiol (“CBD”). On June 30, 2021, the Company entered into a Securities Exchange Agreement (the “Exchange Agreement”) with Panacea Life Sciences, Inc. (“Panacea”) a CBD company, and the stockholders of Panacea. Pursuant to the Exchange Agreement, the former Panacea stockholders assumed majority control of the Exactus and all operations are now operated by Panacea, which as a result of the share exchange became a wholly-owned subsidiary of the Exactus. In October 2021 the Company changed its name from Exactus, Inc. to Panacea Life Sciences Holdings, Inc.

The Company operates in one segment with a focus on developing and producing high-quality, medically relevant, legal, hemp-derived cannabinoid products for consumers and pets.

NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of presentation and principles of consolidation

On June 30, 2021 the Company merged with Panacea. The merger is accounted for as a reverse acquisition and recapitalization in accordance with the Financial Accounting Standards Board (ASC 805, Business Combinations). Management evaluated the guidance contained in ASC 805 with respect to the identification of the acquirer in the merger and concluded, based on a consideration of the pertinent facts and circumstances, that Panacea acquired Exactus for financial accounting purposes. This determination is primarily based on Panacea stockholders comprising a relative majority of the voting power of the Company and having the ability to nominate the members of the board of directors of Exactus after the Merger, Panacea’s operations prior to the Merger comprising the only ongoing operations of the Company following the Merger, and Panacea’s senior management prior to the Merger comprising a majority of the senior management of the Company following the Merger. Accordingly, for accounting purposes, the financial statements of the Company represent a continuation of the financial statements of Panacea with the Merger being treated as the equivalent of Panacea issuing stock for the net assets of Exactus, accompanied by a recapitalization whereby no goodwill or other intangible assets are recorded. Transactions and balances prior to the Merger are those of Panacea. The shares and net loss per share available to holders of Panacea’s common stock prior to the Merger have been retroactively restated as shares reflecting the exchange ratio established in the Exchange Agreement.

The consolidated financial statements represent the accounts and balances for Panacea through June 30, 2021, and the consolidated balances and activities of the Company and its wholly owned subsidiary, Panacea, from that date forward. All significant consolidated transactions and balances have been eliminated in consolidation.

All share and per share numbers have been retroactively adjusted to give effect to a 1-for-28 reverse stock split effective October 25, 2021.

F-7

Going concern

These audited consolidated financial statements are presented on the basis that the Company will continue as a going concern. Panacea has merged with Exactus, so the below items reflect stand-alone historical results of Panacea through June 30, 2021 and the combined financial information thereafter. The going concern concept contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since our inception in later 2017, we have generated losses from operations, except for some slight profits in a few quarters. As of December 31, 2022, our accumulated deficit was $25.9 million, and we had $1.1 million in cash and liquid stock. As of December 31, 2022 the 1,203,000 shares of common stock we hold in 22nd Century Group, Inc. (NASDAQ:XXII) (“XXII”) were valued at approximately $1.1 million. The XXII stock is pledged to secure a $4,062,713 promissory note in favor of Quintel-MC, Incorporated (“Quintel”) and a $1,685,685 promissory note in favor of Leslie Buttorff, CEO of the Company, but can be used in operations as the CEO determines. Quintel-MC, Inc. is wholly owned Company of the CEO. These items are shown on the balance sheet as related party loans. The current plan with respect to the XXII stock is to hold this stock during the short-term. We also currently do not have sufficient cash flow to pay our ongoing financial obligations on a consistent basis.

These factors raise doubt about the Company’s ability to continue as a going concern for a period of 12 months from the issuance date of these financial statements. Management plans to raise additional capital to fund operations, until the Company achieves and maintains profitable operations and cash flows. Management cannot provide assurance that the issuance of any additional shares of common stock, preferred stock or convertible securities could be substantially dilutive to our shareholders. In addition, adequate additional funding may not be available to us on acceptable terms, or at all. If we areThese audited consolidated financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to raise capital, we will be forced to delay, reduce or eliminate our research and development programs and may not be able to continue as a going concern.

F-6
NOTE 3. SIGNIFICANT ACCOUNTING POLICIES
Basiseconomic activity which is likely to continue to reduce the future demand for a broad variety of Presentation.goods and services, while also disrupting sales channels, marketing activities and supply chains for an unknown period of time until the virus is fully contained. The Financial StatementsCompany’s business operations have been negatively impacted by the COVID-19 pandemic and related disclosuresevents and the Company expects this impact on its revenue and results of operations, the size and duration of which is currently difficult to predict. However, adverse consequences from COVID-19 and recent supply chain disruptions and delays may hinder our ability to continue our operations and generate revenue. The impact to date has included a decline in CBD product and sales demand.

Use of Estimates

The audited consolidated financial statements have been prepared pursuant to the rules and regulations of the SEC.  The Financial Statements have been prepared using the accrual basis of accounting in accordance with Generally Accepted Accounting Principles (“GAAP”) of the United States.

Use of Estimates. The Company prepares its financial statements in conformity with accounting principles generally accepted inUS GAAP and required management of the United States of America ("GAAP") which require managementCompany to make estimates and assumptions that affect the reported amountsin preparation of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period.these statements. Actual results couldmay differ significantly from those estimates. Significant estimates made by management include but are not limited to the useful life of property and equipment, incremental borrowing rate used in the calculation of right of use asset and lease liability, reserves for inventory, allowance for doubtful accounts, revenue allocations, valuation allowance on deferred tax assets, assumptions used in assessing impairment of long-term assets, assumptions used in the calculation of net realizable value of inventory and fair value of non-cash equity transactions.

F-8

Cash and Cash Equivalents

For purposes of balance sheet presentation and reporting of cash flows, the Company considers all unrestricted demand deposits, money market funds and highly liquid debt instruments with an original maturity of less than 90 days to be cash and cash equivalents. There were no cash equivalents. The Company places its cash and cash equivalents with high-quality financial institutions. At times, balances in the Company’s cash accounts may exceed the Federal Deposit Insurance Corporation (“FDIC”) limit. On December 31, 2022 and 2021, the Company’s cash balances did not exceed the FDIC limit.

Accounts Receivable

Accounts receivable are generally unsecured. The Company establishes an allowance for doubtful accounts receivable based on the age of outstanding invoices and management’s evaluation of collectability. Accounts are written off after all reasonable collection efforts have been exhausted and management concludes that likelihood of collection is remote. Any future recoveries are applied against the allowance for doubtful accounts. As of December 31, 2016,2022 and December 31, 2021, we did not believe we needed to reserve for any doubtful accounts, respectively. The Company’s accounts receivable policy changed in 2020 to only provide larger, well-established companies with Net 30 payment terms. For all other sales they are paid by credit card or wires received before the Company's accountsproduct is shipped to the customer.

Inventory

Inventories are stated at lower of cost or net realizable value. Inventories of purchased materials are valuated using a moving average method and managed by first in first out basis (FIFO). Inventories of internally manufactured materials are valuated using a standard costing method and are also managed on a FIFO basis. Production related costs that are capitalized as inventory as part of the standard cost valuation include the direct materials consumed, direct labor used, indirect labor used, and manufacturing overhead. Overhead is calculated based on specific manufacturing process and allocated on an order-by-order basis. Production variances that occur between standard cost valuation and actual costs are expensed as incurred in the income statement as part of cost of goods sold.

Marketable securities

The Company’s marketable securities consist of 1,227,017 and 1,203,000 shares of XXII as of December 31, 2022 and 2021, respectively, which are classified as available-for-sale and included significant estimates relating to recovery/executionin current assets. (see Note 2 – Going Concern). Securities are valued based on prepayments made on clinical research services.

Stock-Based Compensation. We recognize compensation expensemarket prices for stock-based compensation in accordance with ASC Topic 718. For employee stock-based awards, we calculate theidentical assets using third party certified pricing sources. Available-for-sale securities are carried at fair value with unrealized and realized gains and losses reported as a component of the award on the date of grant using the Black-Scholes method for stock optionsincome (loss). Realized gains and the quoted price of our common stock for unrestricted shares; the expense is recognized over the service period for awards expected to vest. For non-employee stock-based awards, we calculate the fair value of the award on the date of grant in the same manner as employee awards, however, the awardslosses, if any, are revalued at the end of each reporting period and the pro rata compensation expense is adjusted accordingly until such time the nonemployee award is fully vested, at which time the total compensation recognized to date equals the fair value of the stock-based award as calculated on the measurement date, which is the date at which the award recipient’s performance is complete. The estimation of stock-based awards that will ultimately vest requires judgment,specific identification method and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative adjustmentincluded in other income in the period estimates are revised. We consider many factors when estimating expected forfeitures, including typesconsolidated statements of awards, employee class, and historical experience.
We may issue restricted stock to consultants for various services. Cost for these transactions are measured at the fair value of the consideration received or the fair value of the equity instruments issued, whichever is measurable more reliably measurable. The value of the common stock is measured at the earlier of (i) the date at which a firm commitment for performance by the counterparty to earn the equity instruments is reached or (ii) the date at which the counterparty's performance is complete.
Share-based expense totaled $100,000 and $5,0000 for the year ended December 31, 2016 and 2015, respectively.
Research and Development Expenses. We follow ASC 730-10, “Research and Development,” and expense research and development costs when incurred.  Accordingly, third-party research and development costs, including designing, prototyping and testing of product, are expensed when the contracted work has been performed or milestone results have been achieved. Indirect costs are allocated based on percentage usage related to the research and development. Research and development costs of $369,344 on the new business focus and $77,344 for the former business were incurred for the year ended December 31, 2016 and 2015, respectively.
Revenue Recognition. We recognize revenue when it is realized or realizable and estimable in accordance with ASC 605, “Revenue Recognition”. All revenue is recognized when (i) persuasive evidence of an arrangement exists; (ii) the service or sale is completed; (iii) the price is fixed or determinable; and (iv) the ability to collect is reasonably assured.  
operations.

Fair Value Measurements. WeMeasurements

The Company adopted the provisions of ASCAccounting Standard Codification (“ASC”) Topic 820, “Fair Value Measurements and Disclosures”, which defines fair value as used in numerous accounting pronouncements, establishes a framework for measuring fair value, and expands disclosure of fair value measurements

measurements. The Company’s balance sheet includes certain financial instruments. The carrying amounts of current assets and current liabilities approximate theirguidance prioritizes the inputs used in measuring fair value because of the relatively short period of time between the origination of these instruments and their expected realization.
F-7
ASC 820, “Fair Value Measurements and Disclosures,” defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fairthree-tier value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based onamong the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy are described below:
following:

Level 1 - Unadjusted1—Valuations based on unadjusted quoted prices in active markets that are accessible at the measurement date for identical unrestricted assets or liabilities that the Company has the ability to access.
Level 2 - Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly, including2—Valuations based on quoted prices for similar assets or liabilities in active markets;markets, quoted prices for identical or similar assets or liabilities in markets that are not active;active and models for which all significant inputs other than quoted prices that are observable, for the asseteither directly or liability (e.g., interest rates); andindirectly.
Level 3—Valuations based on inputs that are derived principally from or corroborated by observable market data by correlation or other means.unobservable and significant to the overall fair value measurement.

F-9
 Level 3 - Inputs that are both significant to the fair value measurement and unobservable.
Fair

The following table shows, by level within the fair value estimates discussed herein are based upon certain market assumptionshierarchy, the Company’s assets and pertinent information available to managementliabilities at fair value on a recurring basis as of December 31, 2016.

Cash2022, and Cash EquivalentsWe consider all highly liquid investments purchased with an original maturityDecember 31, 2021:

SCHEDULE OF FAIR VALUE ASSETS MEASURED ON RECURRING BASIS

  December 31, 2022  December 31, 2021 
  Total  Level 1  Level 2  Level 3  Total  Level 1  Level 2  Level 3 
Marketable securities $1,107,362  $1,107,362  $-  $-  $3,791,483  $3,791,483  $-  $- 
Total $1,107,362  $1,107,362  $-  $-  $3,791,483  $3,791,483  $-  $- 

There were no transfers of three monthsmarketable securities into or less to be cash equivalents. The carrying valueout of those investments approximates their fair market value due to their short maturity and liquidity. Cash and cash equivalents include cash on hand and amounts on deposit with financial institutions, which amounts may at times exceed federally insured limits.Level 1 during the years ended December 31, 2022, or 2021.

SCHEDULE OF MARKETABLE SECURITIES

  December 31, 2022 
Balance at beginning of year $3,791,483 
Sale of securities  (46,832)
Realized gain on sale of securities  22,816 
Unrealized gain on marketable securities, net  (2,660,105)
Balance at end of period $1,107,362 

As of December 31, 2016, we had 2022, the Company has no liabilities that are re-measured at fair value.

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight–line method on the various asset classes over their estimated useful lives, which range from three to ten years when placed in service. The cost of repairs and maintenance is expensed as incurred; major replacements and improvements are capitalized. When assets are retired or disposed of, the cost and accumulated depreciation are removed from the accounts, and any resulting gains or losses are included in income in the year of disposition.

Intangible Assets and Goodwill

The Company has intangible assets. Goodwill is comprised of the purchase price of business combinations in excess of the fair market value assigned at acquisition to the tangible and intangible assets acquired. Goodwill is not amortized. The Company tests goodwill for impairment on an annual basis. The Company performed its most recent goodwill impairment using a discounted cash flow analysis and cash equivalentsfound that the fair value exceeded the carrying value. It has $2.189 million of $1,055,336,goodwill from the acquisition of the assets of Phoenix Life Sciences, Inc. in October 2017, and intangible assets of $0 as of December 31, 2015, we had cash2022 and cash equivalents of $0 and a bank overdraft of $1,172. As of December 31, 2016, we had approximately $805,336 in excess of FDIC insured limits.

Restricted Cash. The carrying amounts of cash and cash equivalent items which are restricted as to withdrawal or usage. Restrictions may include legally restricted deposits held as compensating balances against borrowing arrangements, contracts entered into with others, or entity statements of intention with regard to particular deposits; however, time deposits and short-term certificates of deposit are not generally included in legally restricted deposits. At December 31, 2016 and 2015, the Company's current restricted cash consisted of cash held in trust account of $0 and $72,342, respectively.
Marketable Securities. The Company’s marketable equity securities have been classified and accounted$0.061 million for as available-for-sale.  Management determines the appropriate classification of its investments at the time of purchase and reevaluates the designations at each balance sheet date.  We classify our marketable equity securities as either short-term or long-term based on the nature of each security and its availability for use in current operations.  Our marketable equity securities are carried at fair value, with the unrealized gains or losses reported as a component of shareholder’s equity. Adjustments resulting from the change in fair value, included in accumulated other comprehensive income (loss) in shareholder’s equity, were $0 and $6,210 as of December 31, 2016 and 2015, respectively. We recognized an impairment2021. In the acquisition of $10,215 in our marketable securities forPhoenix, the year ended December 31, 2015.
Long-Lived Assets Including Other Acquired Intangible Assets. Property and equipment is stated at cost.  Depreciation is computed by the straight-line method over estimated useful lives,Company acquired product formulas which is between 3 yearsclassified as an intangible asset.

SCHEDULE OF INTANGIBLE ASSETS AND GOODWILL

Estimated Life
Goodwill from Phoenix AcquisitionTested Yearly for Impairment
Intangibles – Formulations5 Years

  December 31, 2022  December 31, 2021 
Goodwill $2,188,810  $2,188,810 
Intangibles – Formulations  307,001   307,001 
Less accumulated amortization  (307,001)  (245,600)
Net intangible assets $-  $61,401 

F-10

Leases

The Company determines if an arrangement is a lease at inception. Contracts containing a lease are further evaluated for computer equipmentclassification as an operating or finance lease. In determining the leases classification, the Company assesses among other criteria: (i) 75% or more of the remaining economic life of the underlying asset is a major part of the remaining economic life of that underlying asset; and 5-20 years for production equipment.   The carrying amount(ii) 90% or more of all long-lived assets is evaluated periodically to determine if adjustment to the depreciation and amortization period or the unamortized balance is warranted.

F-8
Long-lived assets such as property, equipment and identifiable intangibles are reviewed for impairment whenever facts and circumstances indicate that the carrying value may not be recoverable.  When required impairment losses on assets to be held and used are recognized based on the fair value of the asset.  Theunderlying asset comprises substantially all of the fair value is determinedof the underlying asset. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities and long-term operating lease liabilities in the Company’s consolidated balance sheets. Finance leases are included in property, plant and equipment, net, other current liabilities, and long-term finance lease liabilities in the Company’s consolidated balance sheets. ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. For leases with terms greater than 12 months, the Company records the ROU asset and liability at commencement date based on estimates of future cash flows, marketthe present value of lease payments according to their term.

The Company uses incremental borrowing rates based on the estimated rate of interest for collateralized borrowing over a similar assets, if available,term of the lease payments at commencement date. The ROU asset also includes any lease payments made and excludes lease incentives. Lease terms may include options to extend or independent appraisals, if required.  Ifterminate the lease when it is reasonably certain that the Company will exercise that option. Lease expenses are recognized on a straight-line basis over the lease term or the useful life of the leased asset.

In addition, the carrying amount of the long-lived asset is not recoverable from its undiscounted cash flows, an impairment loss is recognized for the difference between the carrying amountROU and fair value of the asset.  When fair values are not available, we estimate fair value by using the expected future cash flows discounted at a rate commensurate with the risk associated with the recovery of the assets.  We recognized impairment losses of $4,080 and $20,625 for the year ended December 31, 2016 and 2015, respectively.

Related Parties. We follow ASC 850,” Related Party Disclosures,” for the identification of related parties and disclosure of related party transactions.  
Income Taxes.  We account for income taxes under ASC 740 “Income Taxes.”  Under the asset and liability method of ASC 740, deferred tax assets andlease liabilities are recognized for the future tax consequences attributable to differences between the financial statements carrying amounts of existing assets and liabilities and their respective tax basis.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  Under ASC 740, the effect on deferred tax assets and liabilities ofremeasured if there is a modification, a change in tax rates is recognized in incomethe lease term, a change in the periodin-substance fixed lease payments or a change in the enactment occurs.  A valuation allowanceassessment to purchase the underlying asset.

Convertible Notes Payable

The Company has issued convertible notes, which contain variable conversion features, whereby the outstanding principal and accrued interest automatically convert into common shares at a fixed price which may be a discount to the common stock at the time of conversion. Some of the conversion features of these notes are contingent upon future events, whereby, the holder agreed not to convert until the contingent future event has occurred.

Revenue Recognition

The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers.

The Company accounts for a contract when it has been approved and committed to, each party’s rights regarding the goods or services to be transferred have been identified, the payment terms have been identified, the contract has commercial substance, and collectability is providedprobable. Revenue is generally recognized net of allowances for certain deferred tax assets if it is more likely thanreturns and any taxes collected from customers and subsequently remitted to governmental authorities. However, the Company’s sales are primarily through retail stores, purchase orders or ecommerce; thus, currently contract liabilities are negligible. The Company does not thathave any multiple-element arrangements.

Some of the Company’s contract liabilities consist of advance customer payments. Contract liability results from transactions in which the Company willhas been paid for products by customers, but for which all revenue recognition criteria have not realize tax assets through future operations. Deferred tax assets totaled $0yet been met. Once all revenue recognition criteria have been met, the contract liabilities are recognized. The Company recorded $368,065 and $24,585 in advanced customer payments as of December 31, 20162022, and 2015.December 31, 2021, respectively, and these amounts are included in the balance sheet line item of accounts payable and accrued expenses. The customer payments have increased as the nutraceutical manufacturing business results in larger contracts.

SCHEDULE OF REVENUE FROM CONTRACT WITH CUSTOMER

  December 31, 2022  December 31, 2021 
Balance, beginning of period $24,585  $121,300 
Payments received for unearned revenue  412,891   41,465 
Revenue earned  69,411   138,180 
Balance, end of period $368,065  $24,585 

Revenue is recognized when a customer obtains control of promised goods or services and is recognized in an amount that reflects the consideration that an entity expects to receive in exchange for those goods or services. In addition, the standard requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The amount of revenue that is recorded reflects the consideration that the Company expects to receive in exchange for those goods. The Company applies the following five-step model in order to determine this amount: (i) identification of the promised goods in the contract; (ii) determination of whether the promised goods are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.

Revenue related to the sale of products is recognized once goods have been sold to the customer and the performance obligation has been completed. In both contracted purchase and retail sales, we offer consumer products through our online stores. Revenue is recognized when control of the goods is transferred to the customer. This generally occurs upon our delivery to a third-party carrier or, to the customer directly. Revenue from tolling services is recognized when the performance obligation, such as processing of the material, has been completed and output material has been transferred to the customer.

F-11

Revenue is generally recognized net of allowances for returns and any taxes collected from customers and subsequently remitted to governmental authorities. Some of the Company’s contract liabilities consist of advance customer payments. A contract liability results from transactions in which the Company has been paid for products by customers, but for which all revenue recognition criteria have not yet been met. Once all revenue recognition criteria have been met, the contract liabilities are recognized. However, the Company’s sales are primarily through retail stores, purchase orders or ecommerce. The Company does not have any multiple-element arrangements.

Shipping and Handling Costs

The Company accounts for shipping and handling fees in accordance with ASC 606. The amounts charged to customers for shipping products are recognized as revenues and the related freight costs of shipping products are classified in general and administrative costs as incurred. Shipping costs are included as a component of general and administrative and were $40,409 and $16,564 for December 31, 2022, and December 31, 2021, respectively. The increase is due to higher postage costs and larger freight shipments.

Advertising & Marketing

Advertising costs are expensed when incurred. Included in this category are expenses related to public relations, investor relations, new package design, website design, design of promotional materials, cost of trade shows, cost of products given away as promotional samples, and paid advertising. The Company recorded advertising costs included in general and administrative costs of $209,254 and $377,916 for the years ended December 31, 2022 and 2021, respectively.

Segment Information

The Company follows the provisions of ASC 280-10 Segment Reporting. This standard requires that companies disclose operating segments based on the manner in which management disaggregates the Company in making internal operating decisions. Segment identification and selection is consistent with the management structure used by the Company’s chief operating decision maker to evaluate performance and make decisions regarding resource allocation, as well as the materiality of financial results consistent with that structure. Based on the Company’s management structure and method of internal reporting, the Company has one operating segment. The Company’s chief operating decision maker does not review operating results on a disaggregated basis; rather, the chief operating decision maker reviews operating results on an aggregate basis.

Earnings per Share. We compute

The Company computes basic and diluted earnings per share amounts in accordance with ASC Topic 260, Earnings“Earnings per ShareShare”. Basic earnings per share is computed by dividing net income (loss) available to common shareholdersstockholders by the weighted average number of common shares outstanding during the reporting period. Diluted earnings per share reflects the potential dilution that could occur if preferred stock options and other commitmentsconverted to issue common stock were exercised or equity awards vest resulting inand warrants are exercised. Preferred stock and warrants are excluded from the issuance of common stock that coulddiluted earnings per share in the earnings of the Company. As ofcalculation if their effect is anti-dilutive.

The Business Combination on December 31, 2016 and 2015,2021 was accounted for as a recapitalization of equity structure. In October 2021 the Company had 14,784,001 and 0 dilutive potential commoncompleted 1-for-28 reverse stock split. Pursuant to GAAP, the Company retrospectively recasted the weighted-average shares respectively.

Comprehensive Income (Loss). Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. The Company is required to record all componentsincluded within its consolidated statements of comprehensive income (loss) in the financial statements in the period in which they are recognized. Net income (loss) and other comprehensive income (loss), net of their related tax effect, arrived at a comprehensive income (loss).  Other comprehensive loss was $0operations for the yearyears ended December 31, 20162022, and 2015.December 31, 2021. The basic and diluted weighted-average Panacea ordinary shares are retroactively converted to shares of the Company’s common stock to conform to the recasted consolidated statements of stockholders’ equity (deficit  ).

SCHEDULE OF ANTI-DILUTIVE DILUTED LOSS PER SHARE

  2022  2021 
  Years ended December 31, 
  2022  2021 
Convertible note payable  -   - 
Restricted Stock  -   - 
Options to purchase common stock  -   - 
Warrants to purchase common stock  -   - 
Series A Convertible Preferred  -   250,000 
Series B-1 Convertible Preferred  6,679   6,679 
Series B-2 Convertible Preferred  26,786   26,786 
Series C Convertible Preferred  2,289,220   2,289,220 
Series C-1 Convertible Preferred  1,064,908   1,064,908 
Series C-2 Convertible Preferred  2,050,000   2,050,000 
Series D Convertible Preferred  1,628,126   1,628,126 
Total  -   - 

F-12
Recent Accounting Pronouncements
During

Income taxes

The Company accounts for income taxes in accordance with ASC 740, “Income Taxes”. ASC 740 requires an asset and liability approach for financial accounting and reporting for income taxes and established for all the first quarter of 2015, the company adopted FASB’s guidance on reporting discontinued operations and disclosures of disposals of components of an entity. This standard raises theentities a minimum threshold for a disposal to qualify as a discontinued operationfinancial statement recognition of the benefit of tax positions and requires new disclosures of both discontinued operations and certain other disposalsexpanded disclosures. The provision for income taxes is based upon income or loss after adjustment for those permanent items that doare not meet the definition of a discontinued operation. The adoption of this guidance has not had a material impact on its financial position, results of operations or cash flows.

During the fourth quarter of 2015, the Company adopted ASU 2015-03, which requires debt issuance costs to be presentedconsidered in the balance sheet as a direct deduction fromdetermination of taxable income. Deferred income taxes represent the carrying valuetax effects of differences between the financial reporting and tax basis of the associatedCompany’s assets and liabilities at the enacted tax rates in effect for the years in which the differences are expected to reverse. The Company evaluates the recoverability of deferred tax assets and establishes a valuation allowance when it is more likely than not that some portion or all the deferred tax assets will not be realized. Management makes judgments as to the interpretation of the tax laws that might be challenged upon an audit and cause changes to previous estimates of tax liability. In management’s opinion, adequate provisions for income taxes have been made. If actual taxable income by tax jurisdiction varies from estimates, additional allowances or reversals of reserves may be necessary.

Recently Issued Accounting Standards

In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40), Accounting for Convertible Instruments and Contract’s in an Entity’s Own Equity. The ASU simplifies accounting for convertible instruments by removing major separation models required under current GAAP. Consequently, more convertible debt liability, and amortization of those costs shouldinstruments will be reported as interest expense. Thisa single liability instrument with no separate accounting for embedded conversion features. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, which will permit more equity contracts to qualify for it. The ASU simplifies the diluted net income per share calculation in certain areas. The ASU is effective for annual and interim periods beginning after December 15, 2015,31, 2021, and early adoption is permitted for financial statements that have not been previously issued. The new guidance should be applied on a retrospective basis for each period presented in the balance sheet. The adoption of this guidance has not had a material impact on its financial position, results of operations or cash flows.

In September 2015, the FASB issued ASU 2015-16, “Simplifying the Accounting for Measurement –Period Adjustments.” Changes to the accounting for measurement-period adjustments relate to business combinations. Currently, an acquiring entity is required to retrospectively adjust the balance sheet amounts of the acquiree recognized at the acquisition date with a corresponding adjustment to goodwill as a result of changes made to the balance sheet amounts of the acquiree. The measurement period is the period after the acquisition date during which the acquirer may adjust the balance sheet amounts recognized for a business combination (generally up to one year from the date of acquisition). The changes eliminate the requirement to make such retrospective adjustments, and, instead require the acquiring entity to record these adjustments in the reporting period they are determined. The new standard is effective for both public and private companies for periods beginning after December 15, 2015. The adoption of this guidance has not had a material impact on its financial position, results of operations or cash flows.
In November 2015, the FASB issued (ASU) 2015-17, “Balance Sheet Classification of Deferred Taxes.” Currently deferred taxes for each tax jurisdiction are presented as a net current asset or liability and net noncurrent asset or liability on the balance sheet. To simplify the presentation, the new guidance requires that deferred tax liabilities and assets for all jurisdictions along with any related valuation allowances be classified as noncurrent in a classified statement of financial position. This guidance is effective for interim and annual reporting periods beginning after December 15, 2016, and early adoption is permitted. The Company has adopted this guidance in the fourth quarter of the year ended December 31, 2015 on a retrospective basis. The adoption of this guidance did not have a material impact on the Company’s financial position, results of operations or cash flows, and did not have any effect on prior periods due to the full valuation allowance against the Company’s net deferred tax assets.
Recent Accounting Pronouncements Issued But Not Adopted as of December 31, 2016
In August 2014, the FASB issued ASU 2014-15, "Presentation of Financial Statements – Going Concern (Subtopic 205-40), effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. This standard provides guidance about management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. The guidance is effective for annual reporting periods ending after December 15, 2016, and early adoption is permitted. The Company adopted this guidance on January 1, 2017. The Company does not expect the adoption of this guidance to have any impact on its financial position, results of operations or cash flows.
In February 2015, the FASB issued ASU 2016-02, Leases (Topic 842), which amends the FASB Accounting Standards Codification and creates Topic 842, "Leases." The new topic supersedes Topic 840, "Leases," and increases transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and requires disclosures of key information about leasing arrangements. The guidance is effective for reporting periods beginning after December 15, 2018. ASU 2016-02 mandates a modified retrospective transition method. The adoption of this guidance is not expected to have a material impact on the Company's consolidated financial statements.
In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting, which amends Accounting Standards Codification (“ASC”) Topic 718, Compensation – Stock Compensation. ASU 2016-09 simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 is effective for fiscal years beginning after December 15, 2016,2020, and interim periods within those fiscal years and early adoptionyears. The Company is permitted. The adoption ofcurrently evaluating the impact that this new guidance is not expected towill have a material impact on the Company'sits consolidated financial statements.

In August 2016,May 2021, the FASBFinancial Accounting Standards Board (“FASB”) issued ASU 2016-15, Cash Flow Statements, Classification2021-04 “Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation— Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815- 40) Issuer’s Accounting for Certain Modifications or Exchanges of Certain Cash ReceiptsFreestanding Equity-Classified Written Call Options” which clarifies and Cash Payments, which addresses eight specific cash flow classification issues with the objective of reducingreduces diversity in practice.an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. An entity should measure the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange as follows: i) for a modification or an exchange that is a part of or directly related to a modification or an exchange of an existing debt instrument or line-of-credit or revolving-debt arrangements (hereinafter, referred to as a “debt” or “debt instrument”), as the difference between the fair value of the modified or exchanged written call option and the fair value of that written call option immediately before it is modified or exchanged; ii) for all other modifications or exchanges, as the excess, if any, of the fair value of the modified or exchanged written call option over the fair value of that written call option immediately before it is modified or exchanged. The amendments in this Update are effective for public businessall entities for fiscal years beginning after December 15, 2017, and2021, including interim periods within those fiscal years. Early adoptionAn entity should apply the amendments prospectively to modifications or exchanges occurring on or after the effective date of the amendments. The Company is permitted. The adoptioncurrently evaluating the impact of this guidance isstandard on its consolidated financial statements.

The Company does not expecteddiscuss recent pronouncements that are not anticipated to have a materialan impact on or are unrelated to its financial condition, results of operations, cash flows or disclosures.

NOTE 3 – PROPERTY, EQUIPMENT, NET OF ACCUMULATED DEPRECIATION

Property and equipment, net including any major improvements, are recorded at historical cost. The cost of repairs and maintenance is charged against operations as incurred. Depreciation is calculated using the Company's consolidated financial statements.straight-line method over the estimated useful lives of the related assets, generally as follows:

SCHEDULE OF PROPERTY PLANT AND EQUIPMENT USEFUL LIVES

Estimated Life
Computers and technological assets35 Years
Furniture and fixtures3 5 Years
Machinery and equipment510 Years
Leasehold improvement10 Years

Property and equipment, net consists of the following:

SCHEDULE OF PROPERTY AND EQUIPMENT

  December 31, 2022  December 31, 2021 
Computers and technological assets $3,776,320  $3,514,421 
Furniture and fixtures  55,950   55,950 
Machinery and equipment  7,765,466   7,530,787 
Land  92,222   92,222 
Leasehold Improvements  1,508,915   1,508,915 
Total  13,198,873   12,702,295 
Less accumulated depreciation  (5,522,878)  (3,862,313)
Total Property and equipment, net $7,675,995  $8,839,982 

Depreciation expenses for the years ended December 31, 2022 and 2021 were $1,669,690 and $1,675,786 respectively.

F-13

the following components:

SCHEDULE OF INVENTORY

  December 31, 2022  December 31, 2021 
Raw Materials $870,530  $970,393 
Semi-Finished  1,863,501   1,466,763 
Finished Goods  1,694,574   1,805,779 
Packaging  20,120   15,549 
Trading  -   5,793 
Total $4,448,725  $4,264,277 

NOTE 4. AGREEMENTS

Through5 –OPERATING LEASE RIGHT-OF-USE ASSETS AND OPERATING LEASE LIABILITIES – RELATED PARTY

Right of Use

The Company adopted Accounting Standards Update (“ASU”) No. 2016-02, “Leases” (“ASC 842”) on January 1, 2019, the Share Exchange, thestart of our 2019 fiscal year. The Company acquired an exclusive license agreement (the “Licensing Agreement”) between Exactus BioSolutionshas one lease arrangement with a related party entered into on December 22, 2018 for a 3-year term commencing January 1, 2019 for certain laboratory facilities with a nine-year extension option. This lease was extended and Digital Diagnostics Inc. (“Digital Diagnostics”) thatnow expires on December 31, 2030. At inception, the Company recognized a Right of Use Asset and a corresponding lease liability in the amount of $4,595,509. The Company’s lease arrangements may contain both lease and non-lease components. The Company has elected to combine and account for lease and non-lease components as a single lease component. The Company has incorporated residual value obligations in leases for which there is such occurrences. Regarding short-term leases, ASC 842-10-25-2 permits an intangible asset.   Pursuantentity to make a policy election not to apply the Licensing Agreement, Digital Diagnostics grantedrecognition requirements of ASC 842 to Exactus BioSolutions an exclusive licenseShort-term leases. The Company has elected not to develop, produce and commercialize certain diagnostic products, includingapply the FibriLyzer and MatriLyzer,ASC 842 recognition criteria to any leases that utilize certain intellectual property rights owned or licensed by Digital Diagnostics. qualify as Short-Term Leases.

The Licensing Agreement provides for Exactus BioSolutions and Digital Diagnostics to collaborate through the various stepsCompany, as of January 1, 2019, leases a portion of the product and device development process, includingproperty (formerly the development, regulatory approval and commercialization stages. Exactus BioSolutions is required to pay Digital Diagnostics,Environmental Protection Agency building) in cash and/or stock, an initial signing payment, milestone fees triggeredGolden, CO from J&N Real Estate, owned by the first regulatory clearance or approvalCEO, a related party with a term expiring on December 31, 2030. The lease consists of eachall laboratory space including testing facilities, water treatment, extraction and production. The lease of the FibriLyzer and the MatriLyzer, and various sales thresholds, and royalty paymentsproperty is based on the fair market rent and triple net saleslease (NNN) values competitive in the marketplace for a cGMP facility. The Company also subleases some of its laboratory space to other CBD companies. This income is presented under the Other Income line items of the products, calculated on a product-by-product basis. In 2016,income statement. The leases vary from short-term monthly leases to 3-year leases but are all month to month.

SCHEDULE OF RIGHT OF USE ASSET AND LIABILITY

  December 31, 2022  December 31, 2021 
Right-of-use assets $3,242,381  $3,595,100 
         
Present value of operating lease liabilities $3,347,331  $3,692,392 
Less: Long-term portion of operating lease liability  (2,987,208)  (3,347,335)
Short-term portion of operating lease liability  360,123   345,057 
Unpaid balances  1,730,136   1,279,033 
Total short-term lease liability obligations $2,090,259  $1,624,090 
Weighted-average remaining lease term (Ends December 31, 2030)  8 years   9 years  
         
Weighted-average discount rate      3.0%

During years ended December 31, 2022 and 2021, we recognized approximately $458,772 and $458,772, respectively in operating lease costs. Operating lease costs are included in operating expenses in our consolidated statement of operations.

Approximate future minimum lease payments for our right of use assets over the Company paid $50,000 to Digital Diagnosticsremaining lease periods as part of the initial signing payment under the Licensing Agreement and $21,659 in legal expenses. As of December 31, 2016, the Company accrued an additional $171,033 in licensing fees due to closing a financing transaction in the fourth quarter2022, are as follows:

Maturity of 2016. No milestones have been met and no milestone fees have been paid or accrued for through December 31, 2016.

The License Agreement is effective until such time as neither Digital Diagnostics nor Exactus Biosolutions has any obligation to the other under the License Agreement in any country with respect to any product. The License Agreement may be terminated by the Company effective upon at least six (6) months written notice if regulatory approval has been obtained in the U.S. or in the European Union, or upon at least three (3) months written notice if regulatory approval has not been obtained in the U.S. or in the European Union. Either party may terminate the License Agreement in the event the other party materially breaches the License Agreement, or becomes insolvent.
On June 30, 2016, in order to conduct a clinical trialoperating lease liabilities for the FibriLyzer and other studies,following years ended:

SCHEDULE OF MATURITY OF OPERATING LEASE LIABILITIES

      
2023 $455,622 
2024 $460,178 
2025 $464,780 
2026 $469,427 
2027 $474,122 
Thereafter $1,451,002 
Total undiscounted operating lease payments $3,775,131 
Less: Imputed interest $(427,800)
Present value of operating lease liabilities $3,347,331 

F-14

NOTE 6 – NOTES PAYABLE

Convertible Note Payable

On November 18, 2021, the Company entered into a Master ServicesSecurities Purchase Agreement (the “MSA”(“SPA”) with IntegriumLincoln Park Capital Fund, LLC (“Integrium”(the “Purchaser”) pursuant to which the Company agreed to sell a 10% original issue discount senior convertible promissory note in the principal amount of $1,100,000 (the “Convertible Note”) and PoC Capital, LLC (“PoC Capital”). Under the MSA, Integrium has agreedfive-year warrants to perform clinical research services in support of the development of POC diagnostics devices.  Integrium is to conduct one or more studies in compliance with FDA regulations and pursuant to the Company’s specific service orders.   PoC Capital has agreed to fund up to the first $1,000,000 in study costs and fees due to Integrium, with all fees in costs in excess of that amount being the Company’s sole responsibility, in exchange for 1,600,000purchase 785,715 shares of the Company’s common stock, 1,733,334 sharespar value $0.0001 per share at an exercise price of newly designated Series C Preferred Stock,$1.40 per share (the “Warrants”) pursuant to the terms and 1,666,667 warrants toconditions of the SPA for a total purchase price of $1,000,000. The note was repaid in full on December 20, 2022.

Paycheck Protection Program Funding U.S. Small Business Administration Loan

On May 28, 2020, the Company received a secured, 30-year, Economic Injury Disaster Loan in the amount of $99,100 from the U.S. Small Business Administration. The loan carries interest at a rate of 3.75% per year, requires monthly payments of principal and interest, and matures in 30 years. Installment payments, including principal and interest, of $483 monthly, will begin 12 months from the date of the promissory Note. The SBA loan is secured by a security interest in the Company’s tangible and intangible assets. The loan proceeds are to be used as working capital to alleviate economic injury caused by the Covid-19 disaster occurring in the month of January 31, 2020, and continuing thereafter. As of December 31, 2022 the current principal balance of this note amounted to $99,100 and accrued interest was approximately $2,047 total for the current and non-current total.

Employer Retention Credit

On February 16, 2022, Panacea received an employer retention credit from the federal government of $253,791.

Note payable-current, related party

As part of the agreement in the reverse merger transaction, certain loan balances (“Quintel Loans”) from Quintel-MC Incorporated, an affiliate of the Company’s CEO, (“Quintel”) and historical interest owed of $1,932,358 were combined into a new promissory note with the principal amount of $4.062 million (“Quintel Note”). The Quintel Note bears annual interest at 12% and was secured by a pledge of certain XXII common stock atowned by Panacea (See Note 2 Going concern).

On June 30, 2021, Panacea issued the Company’s CEO, Ms. Buttorff, a price10% promissory note in the amount of $0.60 per share exercisable for three years.$1,624,000 (the “Buttorff Note”). The Buttorff Note was secured by a pledge of certain XXII common stock owned by Panacea (See Note 2 Going concern). This demand note replaced a prior working capital note that Panacea had issued on January 1, 2021. The Company has accounted $1,000,000 as prepaid expensesan additional line of credit note from Ms. Buttorff of $5,000,000 on July 1, 2021. The terms include an annual interest rate of 10% and a maturity date in 2023.

SCHEDULE OF NOTES PAYABLE RELATED PARTY

  December 31, 2022  December 31, 2021 
Quintel Note $4,062,713  $4,062,713 
CEO Note  5,809,090   2,379,153 
Total related party notes $9,871,803  $6,441,866 

Other long-term liabilities, related party

The Company has recorded a related party liability (“Fixed Asset Loan”) in the balance sheet. See Note 8 below for additional information regarding the Company’s common stock, Series C Preferred Stockamounts of $3,059,474 and warrants.

NOTE 5. PROPERTY AND EQUIPMENT
Property consists of equipment purchased for the production of revenues.  The following table shows the Company’s property and equipment$2,749,638, as of December 31, 20162022, and 2015:
 
 
December 31,
2016
 
 
December 31,
2015
 
 
Estimated Service Lives in Years
 
Production equipment
 $- 
 $900 
  5-20 
Office and computer
  - 
  2,467 
  3 
Total property and equipment
  - 
  3,367 
    
Less accumulated depreciation
  - 
  1,941 
    
   Property and equipment, net
 $- 
 $1,453 
    
Assets are depreciated over their useful lives when placed2021, respectively, relating to building leasehold improvements and SAP software and support fees which were paid by an affiliate company of the CEO. The balance bears interest of 6%, and the maturity date has not yet been determined.

In 2020, the Company recorded an additional related party liability in service.  Depreciation expense was $0the amount of $513,390 in respect of certain building improvements ,due to J&N Real Estate Company (a company owned by the CEO) (“J&N Building Loan”). The balance bears no interest, and $1,627 forthe maturity date has not yet been determined.

Notes payable is summarized as follows.

SCHEDULE OF NOTES PAYABLE

       
  December 31, 2022  December 31, 2021 
Other long-term liabilities, related party        
Fixed Asset Loan $3,059,474  $2,749,638 
J&N Building Loan  513,390   513,390 
Total $3,572,864  $3,263,028 

NOTE 7 - STOCKHOLDERS’ EQUITY

Common stock

The Company’s authorized common stock consists of 650,000,000 shares with a par value of $0.0001 per share.

During the year ended December 31, 2016 and 2015, respectively.

We recognized a disposal loss of $1,453 on computer equipment and an impairment loss of $20,625 on production equipment for the year ended December 31, 2016 and 2015, respectively.
NOTE 6. NOTE PAYABLE
On December 16, 2015, we received a subscription for 2,500,000 shares of our common stock, for $100,000 from one institutional investor.  As of December 31, 2015, we failed to issue the shares. On February 12, 2016, the subscription was rescinded and the $100,000 deposit was mutually agreed to be treated as a short-term loan and the balance of $72,342 in escrow account was shown as Restricted cash on the balance sheet. Accordingly, the $100,000 was recorded as a Note Payable as of December 31, 2015. The Note Payable was unsecured, non-interest bearing, and is due on demand. On February 29, 2016, the Company issued 400,000 shares of Series B-2 Preferred Stock to extinguish the loan.
NOTE 7. INCOME TAXES
As of December 31, 2016, the Company has a deferred tax asset, resulting from benefits of net operating loss carry forward generated from inception, which expire in varying amounts between 2028 and 2036.  
The carry-forwards may be further subject to the application of Section 382 of the Internal Revenue Code of 1986. The Company’s past sales and issuances of common and preferred stock have likely resulted in ownership changes as defined by Section 382 of the Code. The Company has not conducted a Section 382 study to date. It is possible that a future analysis may result in the conclusion that a substantial portion, or perhaps substantially all, of the NOLs and credits will expire due to the limitations of Sections 382 and 383 of the Code. As a result, the utilization of the NOLs and tax credits may be limited and a portion of the carry-forwards may expire unused. The Company has provided a valuation allowance to offset the deferred tax assets due to the uncertainty of realizing the benefits of the net deferred tax asset.
As of December 31, 2016, there was approximately $795,500 in deferred tax assets, which were off-set by an equal valuation allowance.
The Company has not taken positions contrary to the Internal Revenue Code, however, the tax years of 2012 through 2016 remain subject to audit by the Internal Revenue Service.
The tax effects of temporary differences that give rise to the Company’s net deferred tax asset as of December 31, 2016 and 2015 are as follows:
 
 
December 31,
 
 
December 31,
 
 
 
2016
 
 
2015
 
Current tax benefit
 $(545,000)
 $(121,700)
Valuation allowance
  545,000 
  121,700 
Total tax expense
 $- 
 $- 
 
    
    
 
  December 31,  
  December 31,  
 
  2016 
  2015 
Balance forward
 $250,500 
 $128,800 
Change in deferred tax asset
  545,000 
  121,700 
Total deferred tax asset
  795,500 
  250,500 
Valuation allowance
 (795,500)
 (250,500)
Total tax expense
 $- 
 $- 
The Company has net operating loss carryforwards of approximately $2,339,898 included in the deferred tax asset table above for 2016 and 2015, respectively. However, due to limitations of carryover attributes, it is unlikely the company will benefit from these NOL's and thus Management has determined a 100% valuation reserve is required.

NOTE 8. EQUITY TRANSACTIONS
Recapitalization and Change in Control
On February 29, 2016, the Company consummated the Share Exchange, which resulted in a change in control of the Company. As part of this transaction, the Company acquired a $50,000 license agreement and $1,292 in cash and assumed liabilities of $51,000. The Company initially reported an issuance of 32 million shares of newly designated Series B-1 Preferred Stock to the shareholders of Exactus BioSolutions in the Share Exchange. Due to an anticipated pre-acquisition investment in Exactus BioSolutions that was not made, the final total issued shares of Series B-1 Preferred Stock was 30 million.
The Company has considered the guidance pursuant to Rule 11-01(d) of Regulation S-X and related interpretations and has concluded the acquisition of Exactus BioSolutions pursuant to the Share Exchange is the acquisition of an asset and not of a business.  The license agreement and shareholder loans have been accounted for and recorded at historical cost.
Concurrently with the closing of the Share Exchange, the Company closed a private offering of Series B-2 Preferred Stock.  The Company sold a total of 2,084,000 shares of Series B-2 Preferred Stock at an offering price of $0.25 per share, for an aggregate subscription price of $521,000. The Company originally reported a total of 2,884,000 shares of Series B-2 preferred stock being issued in the offering. Due to: (i) an anticipated investment for 1,000,000 shares which was not made, and (ii) an additional subscription for 200,000 shares for which documentation had not been completed at that time, however, the final total issued shares of Series B-2 Preferred Stock was 2,084,000. The shares sold in the offering included 400,000 shares of Series B-2 preferred stock issued to extinguish a $100,000 loan and 204,000 shares of Series B-2 preferred stock issued to former creditors of Exactus BioSolutions in exchange for their release of $51,000 in debt owed by Exactus.  After accounting for these issuances, net cash proceeds from the offering were $370,000.  No underwriting discounts or commissions have been or will be paid in connection with the sale of Series B-2 Preferred Stock.
Also on February 29, 2016, the Company entered into Exchange Agreements with certain holders of common stock holding an aggregate of 393,314 post-split (11,636,170 pre-split) shares of common stock.  Under the Exchange Agreements, these shareholders exchanged their common stock for a total of 4,558,0422021, 100 shares of Series A Preferred Stock. These exchanges consisted of: (i) thirteen common stock holders holding 10,894,070 (pre-split)Shares were converted into 71,429 shares of common stock who exchanged their common stock for 3,458,042 sharesand on March 3, 2022 the Series A Preferred preferred stock was converted to a convertible loan for $385,000, due in March 2023.

F-15

Common stock options

Stock resultingOption Plan

On June 30, 2021 the Company’s stockholders approved the 2021 Equity Incentive Plan (the “2021 Plan”). The 2021 Plan provides for the issuance of 339,522 incentive awards in a (pre-split) exchange ratiothe form of approximately 1 for 3.15,non-qualified and (ii) one shareholderincentive stock options, restricted stock awards, restricted stock unit awards, warrants and preferred stock. The awards may be granted by the Company’s Board of Directors to its employees, directors and officers and to consultants, agents, advisors and independent contractors who under a separately negotiated agreement, exchanged 742,100 (pre-split) shares common stock for 1,100,000 shares of Series A Preferred Stock, resulting at a (pre-split) exchange ratio of approximately 1.48 for 1.  Immediately following such share exchanges,provide services to the Company repurchased 50,000or to a subsidiary of the Company. The exercise price for stock options must not be less than the fair market value of the underlying shares on the date of Series A Preferred Stockgrant. The incentive awards shall either be fully vested and exercisable from a shareholder for a total pricethe date of $50,000.

Reverse Stock Split
Effective March 22, 2016, the Company performed a reverse split of common stock on a 1 for 29.5849 basis, pursuant to the prior approval bygrant or shall vest and become exercisable in such installments as the Board of Directors and a majority of shareholders.  On March 22, 2016,or Compensation Committee may specify. Stock options expire no later than ten years from the effective date of the reverse split, the Company had approximately 3,608,715grant. The aggregate number of shares of common stock which may be issued pursuant to the Plan is 144,621. Unless sooner terminated, the Plan shall terminate in 10 years.

As part of the merger of Exactus, Panacea assumed the Exactus 2018 Equity Incentive Plan (the “2018 Plan”). The 2018 Plan provides for the issuance of incentive awards in the form of non-qualified and incentive stock options, stock appreciation rights, restricted stock awards, and restricted stock unit awards. The awards may be granted by the Company’s Board of Directors to its employees, directors and officers and to consultants, agents, advisors and independent contractors who provide services to the Company or to a subsidiary of the Company. The exercise price for stock options must not be less than the fair market value of the underlying shares on the date of grant. The incentive awards shall either be fully vested and exercisable from the date of grant or shall vest and become exercisable in such installments as the Board or Compensation Committee may specify. Stock options expire no later than ten years from the date of grant. The aggregate number of shares of common stock which may be issued pursuant to the Plan is 339,286. Unless sooner terminated, the Plan shall terminate in 10 years. This plan had 196,491 fully vested options outstanding at the time of the merger. There have been no options granted under this plan subsequent to the merger.

Stock Options

A summary of the stock option activity is presented below:

SCHEDULE OF STOCK OPTIONS

  Options Outstanding as of December 31, 2022 
  Number of Shares Subject to Options  Weighted Average Exercise Price Per Share  Weighted Average Remaining Contractual Life (in years)  Aggregate Intrinsic Value 
Balance at December 31, 2021 -  -  -  - 
Options assumed in merger  196,486  $3.51   3.20  $2,500 
Options granted  -   -   -   - 
Options exercised  -   -   -   - 
Options canceled / expired  -   -   -   - 
Balance at December 31, 2022  196,486  $3.51   2.20  $2,500 
                 
Vested and exercisable at December 31, 2022  196,486  $3.51   3.70  $2,500 

Stock Warrants

On March 3, 2022, the Company entered in an Exchange Agreement with an institutional investor pursuant to which were split into 121,978the Company issued a 10% original issue discount senior convertible promissory note in the principal amount of $385,000 (the “Note”) and five-year warrants to purchase 275,000 shares of the Company’s common stock, par value $0.0001 per share at an exercise price of $1.40 per share in exchange for 350 shares of the Company’s Series A Convertible Preferred Stock. As of December 31, 2022, the Company also had outstanding warrants to purchase an aggregate of 56,377 shares of common stock. These warrants were previously issued by the Company prior to the exchange agreement.

The par valueCompany’s outstanding warrants as of December 31, 2022 are summarized as follows, and all were exercisable at that date.

A summary of the commonCompany’s outstanding warrants is presented below:

SCHEDULE OF WARRANTS OUTSTANDING

  Warrants Outstanding as of December 31, 2022 
  Number of Shares Subject to Warrants  Weighted Average Exercise Price Per Share  Weighted Average Remaining Contractual Life (in years)  

Aggregate

Intrinsic

Value

 
             
Balance on December 31, 2021  56,377  $13.64   2.01   - 
Options granted  275,000   -   -   - 
Options exercised  -   -   -   - 
Options canceled / expired  -   -   -   - 
Balance at December 31, 2022  331,377  $3.48   3.67  $- 
                 
Vested and exercisable at December 31, 2022  331,377  $3.48   3.67  $- 

As of December 31, 2022, the outstanding warrants have no intrinsic value.

F-16

Restricted Stock

A summary of the restricted stock was unchanged at $0.0001 peractivity is presented below:

SUMMARY OF RESTRICTED STOCK

Restricted Stock Common Stock
Balance at December 31, 2021-
Assumed in merger107,993
Balance at December 31, 2022107,993

As of December 31, 2022, there were no unamortized or unvested stock-based compensation costs related to restricted share post-split. All per share informationarrangements. These shares are included in the condensed financial statements gives retroactive effect to the 1 for 29.5849 reverse stock split that was effected on March 22, 2016.

total of outstanding share as of December 31, 2022.

Preferred Stock

The Company’s authorized preferred stock consists of 50,000,000 shares with a par value of $0.0001.  $0.0001.

On February 17, 2016,March 3, 2022, the Board of Directors votedCompany entered into an Exchange Agreement with the Investor pursuant to designate a class of preferred stock entitled Series A Preferred Stock, consisting of upwhich the company agreed to five million (5,000,000) shares, par value $0.0001.  The shares of Series A Preferred Stock were automatically converted to 4,508,042 shares of common stock on March 30, 2016, thirty (30) days afterissue the closing ofNote in the Share Exchange and offering of Series B-2 Preferred Stock.  As a result, there are 4,558,042 Series A preferred stock issued and zero outstanding as of December 31, 2016.

Also on February 17, 2016, the Company’s Board of Directors voted to designate a class of preferred stock entitled Series B-2 Convertible Preferred Stock (“Series B-2 Preferred Stock”), consisting of up to six million (6,000,000) shares, par value $0.0001, with a stated value of $0.25 per share.  With respect to rights on liquidation, winding up and dissolution, holders of Series B-2 Preferred Stock will be paid in cash in full, before any distribution is made to any holder of common or other classes of capital stock, anprincipal amount of $0.25 per share. Shares of Series B-2 Preferred Stock have no dividend rights except as may be declared by$385,000 and the BoardWarrants in its sole and absolute discretion, out of funds legally availableexchange for that purpose. Shares of Series B-2 Preferred Stock are convertible, at the option of the holder, into350 shares of common stock on a one (1) for one (1) basis.  Holders of Series B-2 Preferred Stock have the right to vote as-if-converted to common stock on all matters submitted to a vote of the holders of the Company’s common stock. On February 29, 2016, the Company issued 2,084,000 shares of Series B-2 Preferred Stock.
 On August 1, 2016, the Company closed a private offering of Series B-2 Preferred Stock.  The Company sold a total of 500,000 shares of Series B-2 Preferred Stock to accredited investors at an offering price of $0.25 per share, for an aggregate subscription price of $125,000.  No underwriting discounts or commissions have been paid in connection with the sale of the Series B-2 Preferred Stock.
Effective October 13, 2016, the Company amended the Certificate of Designation for its Series B-2 Preferred Stock to increase the number of shares of the Series B-2 Preferred Stock from 6,000,000 to 10,000,000 shares. There were no other changes to the terms of the Company’s Series B-2A Convertible Preferred Stock.
On October 27, 2016,April 19, 2022, the Company closedfiled a private offeringWithdrawal of Series B-2 Preferred Stock.  The Company sold a total of 6,000,000 shares of Series B-2 Preferred Stock to accredited investors at an offering price of $0.25 per share, for an aggregate subscription price of $1,500,000.  No underwriting discounts or commissions have been or will be paid in connection with the saleDesignation of the Series B-2 Preferred Stock. As of December 31, 2016, 8,584,000 shares of Series B-2 Preferred Stock are issued and outstanding.
On February 29, 2016, the Company’s Board of Directors voted to designate a class of preferred stock entitled Series B-1A Convertible Preferred Stock (“Series B-1 Preferred Stock”), consistingwith the Secretary of up to thirty-two million (32,000,000) shares, par value $0.0001.  With respect to rights on liquidation, winding up and dissolution, the Series B-1 Preferred Stock ranks pari passu to the class of common stock. Shares of Series B-1 Preferred Stock have no dividend rights except as may be declared by the Board in its sole and absolute discretion, out of funds legally available for that purpose. Shares of Series B-1 Preferred Stock are convertible, at the option of the holder, into shares of common stock on a one (1) for one (1) basis. Holders of Series B-1 Preferred Stock have the right to vote as-if-converted to common stock on all matters submitted to a vote of holders of the Company’s common stock. On February 29, 2016, the Company issued 30,000,000 shares of Series B-1 Preferred Stock, of which 2,800,000 remain outstanding as of December 31, 2016.
On June 30, 2016, pursuant to the MSA summarized in Note 4, the Company’s Board of Directors approved a Certificate of Designation authorizing 1,733,334 shares of new Series C Preferred Stock, par value $0.0001.  The Series C Preferred Stock ranks equally with our common stock with respect to liquidation rights and is convertible to common stock on a 1 for 1 basis.  The conversion rights of holders of the Series C Preferred Stock are limited such that no holder may convert any shares of preferred stock to the extent that such holder, immediately following the conversion, would own in excess of 4.99% of our issued and outstanding shares of common stock.  This limitation may be increased to 9.99% upon 61 days written notice by a holder of the Series C Preferred Stock to the Company.  On June 30, 2016, the Company issued 1,733,334 shares of Series C Preferred Stock to PoC Capital valued at $511,334. As of December 31, 2016, 1,733,334 shares of Series C Preferred Stock are issued and outstanding
As of December 31, 2015, no shares of Preferred Stock were issued or outstanding.  
Common Stock
The Company’s authorized common stock consists of 200,000,000 shares with a par value of $0.0001.
The Company automatically converted all outstanding shares of Series A Preferred Stock to common stock on March 30, 2016.  As a result, 4,508,042 shares of common stock were issued in exchange of 4,508,042 shares of Series A Preferred Stock.
Certain shareholders converted their shares of Series B-1 Preferred Stock to common stock on June 15, 2016.  As a result, 27,200,000 shares of common stock were issued in exchange of 27,200,000 shares of Series B-1 Preferred Stock.
On June 30, 2016, pursuant to the MSA summarized in Note 4, the Company issued 1,600,000 shares of common stock to PoC Capital valued at $480,000.
 Pursuant to a services agreement with IRTH Communications, LLC (“IRTH”) in which IRTH agreed to perform certain investor relations, financial communications, and strategic consulting services, the Company issued $100,000 of our common stock, or 141,844 shares, to IRTH on November 18, 2016 in partial consideration for those services. On December 13, 2016, the Company issued an additional 500,000 shares of common stock to IRTH pursuant to an addendum to the services agreement and in consideration of certain additional services, including telemarketing and investor outreach services, to be provided by IRTH.  On February 22, 2017, the Company and IRTH agreed that IRTH would not provide the additional servicespursuant to an addendum to a services agreementState and the 500,0000 sharesState of common stock issued on December 13, 2016 were returned to the Company and retired.
There were 34,071,862 and 515,290 common shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively.
Warrants and Options
On June 30, 2016, pursuant to the MSA summarized in Note 4, the Company issued warrants to purchase 1,666,667 common stock shares for a price of $0.60 per share exercisable for three years to PoC Capital.
These warrants have a grant date fair value of $0.0052 per warrant, determined using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.71%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 27.2%; and (4) an expected life of the warrants of 3 years.
The Company has recorded a prepaid expense on these warrants of $8,667 as of June 30, 2016.
There were 1,666,667 and 0 warrants outstanding at December 31, 2016 and December 31, 2015, respectively.
Nevada.

NOTE 9. 8 - COMMITMENTS AND CONTINGENCIES

Legal Matters

In the ordinary course of business, we enterthe Company enters into agreements with third parties that include indemnification provisions which, in ourits judgment, are normal and customary for companies in ourthe Company’s industry sector. These agreements are typically with business partners, clinical sites, and suppliers. Pursuant to these agreements, wethe Company generally agreeagrees to indemnify, hold harmless, and reimburse indemnified parties for losses suffered or incurred by the indemnified parties with respect to our product candidates,the Company’s products, use of such product candidates,products, or other actions taken or omitted by us. The maximum potential amountnumber of future payments wethe Company could be required to make under these indemnification provisions is unlimited. We haveThe Company has not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of liabilities relating to these provisions is minimal. Accordingly, we havethe Company has no liabilities recorded for these provisions as of December 31, 2016, and 2015.

In the normal course2022.

Concentrations

The Company has no concentration of business, we may be confronted with issues or eventsvendors that may result in a contingent liability. These generally relate to lawsuits, claims, environmental actions or the action of various regulatory agencies. If necessary, management consults with counsel and other appropriate experts to assess any matters that arise. If, in management’s opinion, we have incurred a probable loss as set forth by accounting principles generally acceptedwould impact production costs in the United States, an estimate is made oflonger term.

On the loss, and the appropriate accounting entries are reflected in our financial statements. We do not anticipate that liabilities arising out of currently pending or threatened lawsuits and claims will have a material adverse effect on our financial position, results of operations or cash flows.

NOTE 10. RELATED PARTY CONSIDERATIONS
Some of the officers and directors of the Company are involved in other business activities and may, in the future, become involved in other business opportunities that become available. They may face a conflict in selecting between the Company and other business interests. We have not formulated a policy for the resolution of such conflicts.
For the year ended December 31, 2016, $251,096 was recognized in Research and Development expenses for consulting provided by a director and shareholder. As of December 31, 2016, $101,095 is shown as accrual under accounts payable. In addition, $71,659 was paid and $171,033 was accrued for a director and shareholder during the year ended December 31, 2016 for the Licensing Agreement disclosed in Note 4.
In December 2015, we issued 100,000 shares of common stock to Elliot Maza, our Chief Executive and Chief Financial Officer, for services valued at $5,000.
During the year ended December 31, 2015, we received $497,156 from Fuse Science, Inc. (“Fuse”) and paid $358,808 of expenses on behalf of Fuse, which as of June 30, 2015, owned 7,723,892 (51%) of Spiral shares. Fuse then sold 6,600,000 of their Spiral shares in private transactions, which reduced their ownership to 7.4%.  Of these shares, 6,200,000 were sold for the benefit of Spiral and recorded as a contribution to capital of $25,595.
NOTE 11. SUBSEQUENT EVENTS
In accordance with authoritative guidance, we have evaluated any events or transactions occurring after December 31, 2016, the balance sheet date, through the date of filing of this report and note that there have been no such events or transactions that would require recognition or disclosure in the consolidated financial statements as of andrevenue side, for the year ended December 31, 2016, except2022, there was a concentration of two customers. Both are tolling partners who represent 16% and 10% of total revenue.

In the 3rd Quarter of 2021, we signed a large contract with a convenience store chain. The revenues from the first shipment of CBD products are 16% of the 2021 revenue. We also have a tolling partner concentration and this contract was 18.8% of revenue in 2021.

The other concentration is in the accounts receivable category, where two customer accounts for 50% of the accounts receivable in 2021. One of the three customer contracts is unique in that we produced all the products for them to sell, and they pay Panacea as disclosed below.

the items are sold in the ecommerce marketplace. Thus, until their inventory is depleted, we will have accounts receivable. This customer receivable is 33% of the 50%. In 2021, this same customer was 31% of our total receivables.

The Company has no other contingencies, material commitments, or purchase obligations or sales obligations.

Executive Employment Agreement

On January 6, 2017, Exactus, Inc. (the “Company”)December 31, 2021 the Company entered into an agreementupdated Employment Agreement with BioCapital Partners, LLC (“BioCapital”)Leslie Buttorff pursuant to which BioCapital will provide general financial advisory and consulting services throughMs. Buttorff serves as the Company’s Chief Executive Officer for an initial term of July 1, 2021 to December 31, 2017. In consideration2024 (the “Employment Agreement). Under her Employment Agreement, Ms. Buttorff receives an annual base salary of $380,000. Ms. Buttorff is also entitled to receive (i) a sales commission of 2% of revenue from sales generated by Ms. Buttorff after revenue exceeds $500,000 for those services, the Company agreed to issue to BioCapital, on or about April 6, 2017, a warrant to purchase the Company’sthree consecutive months, (ii) an award of $2.2 million of shares of common stock equal to four percent of the Company’s issued and outstanding capital stock on a fully-diluted basis (the “Warrant”). The Warrant will have an initial exercise price equal to the par valueupon approval of the Company’s common stock for listing on The Nasdaq Capital Market prior to expiration of the term of the Employment Agreement, and (iii) an annual cash performance bonus of up to 100% of her base salary based on the achievement of performance metrics for the applicable fiscal year to be set by the Board of Directors. To date, Ms. Buttorff has not taken a salary, payments have accrued commencing in January, 2021, and the amount due is included in accounts payable.

Under her Employment Agreement, she is entitled to severance payments under termination provisions which are intended to comply with Section 409A of the Internal Revenue Code of 1986, or $0.0001 per share,the Code, and the Regulations thereunder.

F-17

In the event of termination by the Company without “cause” or resignation by Ms. Buttorff for “good reason,” Ms. Buttorff is entitled to receive two years’ base salary, or $780,000, all unreimbursed business expenses and other accrued but unpaid compensation, and any annual bonus earned but not yet paid for any fiscal year ending prior to the fiscal year in which the date of termination occurs. In addition, in the event of termination by the Company without “cause,” subject to certain customary anti-dilution reset adjustments. The Warrant mayexecution of a general release Ms. Buttorff will be exercisedentitled to (i) a settlement amount equal to another two years’ base salary (or a total of $1,560,000) and (ii) an amount equal to the annual bonus which Ms. Buttorff would have been entitled to receive in respect of the year of termination based on the achievement of any performance objectives for the Company.

Generally, “good reason” is defined as (i) any material breach of the Employment Agreement by the holder at any time, in wholeCompany, (ii) the Company’s assignment of Ms. Buttorff to a position that has materially less authority, status, or in part, untilfunctional responsibility than the fourth anniversary of the issuance date.

On January 20, 2017, Robert F. Parker (the “petitioner”) filed a petition in the Supreme Court of the State of New York, County of New York, naming, among others, the Company and Ezra Green, a former shareholder, director and officer ofposition with the Company as respondents. The petition was received byof the commencement date, or the assignment to her of duties that are not those of an executive at the management level, (iii) the reduction of Ms. Buttorff’s base salary, (iv) the requirement that Ms. Buttorff move her primary place of employment more than 30 miles from her initial place of employment, or (v) upon any change of control event as defined in Treasury Regulation Section 1.409A-3(i)(5) provided that within 12 months of the change of control event the Company on February 7, 2017. The petitioner previously had a judgment entered in his favorterminates Ms. Buttorff or fails to obtain an agreement from any successor to perform the Employment Agreement.

Under the terms of her Employment Agreement, Ms. Buttorff is subject to non-competition and against Clear Skies Solar, Inc.non-solicitation covenants during the term of her employment and its wholly owned subsidiary Clear Skies Group, Inc. (together, “Clear Skies”), in the amountfollowing termination of $331,132.45,employment with interest accruing at a rate of 9% per year from November 21, 2014 (the “Judgment”). The Judgment remains outstanding. The petition alleges, among other things, that through a series of allegedly fraudulent conveyances occurring before the Judgment was entered against Clear Skies, the major assets of Clear Skies, which were comprised of various patents, were transferred from Clear Skies to Carbon 612 Corporation (“Carbon”), and from Clear Skies and Carbon to the Company. The petition further alleges, among other things, that the transfers were without fair considerationEmployment Agreement also contains customary confidentiality and rendered Clear Skies, the judgment-debtor, insolvent. The petitioner seeks the entry of a judgment against the Companynon-disparagement covenants.

NOTE 9 - RELATED PARTY TRANSACTIONS

Notes Payable and the other respondents in the amount of the outstanding Judgment, with all accrued interest, reasonable attorneys’ fees and costs and disbursements. We believe the claims against the Company are without merit, and we intend to contest petitioner’s claims and defend the matter vigorously. Given the uncertainty of litigation, the preliminary stage of the case, and the legal standards that must be met for, among other things, successAccrued Interest – Related Parties

For information on the merits, we cannot estimate the reasonably possible loss or range of loss that may result from this action.

On January 26, 2017, the Company closed a private offering of Series B-2 Preferred Stock.  The Company sold a total of 100,000 shares of Series B-2 Preferred Stock to accredited investors at an offering price of $0.25 per share, for an aggregate subscription price of $25,000.  No underwriting discounts or commissions have been or will be paid in connection with the sale of the Series B-2 Preferred Stock.
On February 22, 2017, the Company and IRTH agreed that IRTH would not provide the additional servicespursuant to an addendum to a services agreement(Note 8) and the 500,0000 shares of common stock issued on December 13, 2016 were returnedrelated party loans to the Company and retired.
other related party transactions, see Notes 5 and 6, Operating Lease and Notes Payable.

The accrued interest and interest expenses recorded for related party loans are shown below.

SCHEDULE OF RELATED PARTY TRANSACTIONS LOANS

  December 31, 2022  December 31, 2021 
Accrued Interest        
Related party loan J&N $796,891  $249,939 
Related party loan-CEO loan  271,585   86,060 
Related party loan – Line of credit  282,869   29,235 
Accrued Interest  282,869   29,235 

  Year ended December 31, 2022  Year ended December 31, 2021 
Interest Expense        
Related party loan J&N $546,952  $772,463 
Related party loan-CEO loan  185,525   146,245 
Related party loan – Line of Credit  253,634   29,235 
Interest Expense  253,634   29,235 

Other

The Company continues to hold 1,203,000 shares of XXII stock which is available for trading. As of December 31, 2021, XXII is a common shareholder of the Company. See Subsequent Events for additional details related to XXII resolution.

NOTE 10 – INCOME TAXES

The Company has incurred aggregate net operating losses of approximately $30.604 million for income tax purposes as of December 31, 2021. The net operating losses carry forward for United States income taxes, which may be available to reduce future years’ taxable income. Management believes that the realization of the benefits from these losses appears not more than likely due to the Company’s limited operating history and continuing losses for United States income tax purposes. Accordingly, the Company has provided a 100% valuation allowance on the deferred tax asset to reduce the asset to zero. Management will review this valuation allowance periodically and make adjustments as necessary.

F-18

The following table summarizes the significant differences between the U.S. Federal statutory tax rate and the Company’s effective tax rate for financial statement purposes for the years ended December 31, 2022 and 2021. The company has yet to file income taxes for the year ended December 31, 2021.

SCHEDULE OF EFFECTIVE TAX RATE

December 31, 2022
U.S. federal statutory rate21.0%
Increase (decrease) in taxes resulting from:
Increase in valuation allowance(21.9)%
ROU Assets/Liabilities(2.7)%
State taxes3.6%
Income tax (expense) benefit-%

The Company provided a valuation allowance equal to the deferred income tax asset for the year ended December 31, 2022, because it was not known whether future taxable income will be sufficient to utilize the loss carryforward. The increase in the allowance was $9.997 million in fiscal 2022. Additionally, the future utilization of the net operating loss carryforward to offset future taxable income may be subject to an annual limitation, based upon IRC Section 382/383 Ownership change rules that may have or could occur in the future. The Company does not have any uncertain tax positions or events leading to uncertainty in a tax position. The Company’s 2017, 2018, 2019 and 2020 Corporate Income Tax Returns are subject to Internal Revenue Service examination.

NOTE 13 – SUBSEQUENT EVENTS

Panacea Life Sciences Holdings, Inc. announced on January 30, 2023 that the Company has executed a letter of intent to acquire N7 Enterprises, Inc. Pursuant to the terms of the letter of intent, Panacea would acquire all of the outstanding membership interests of N7 Enterprises in consideration for the issuance of common shares of the Company to the existing shareholders of N7 Enterprises. N7 Enterprises operates an expanding Florida chain of kava and kratom lounges under the Lizard Juice™ and N7 Nitro Kava™ brands founded in 2012, and is also a distributor of CBD, hemp, kratom and kava related products through its New Age Distribution subsidiary, founded in 2022. For its two business segments, N7 Enterprises showed $4.1 million in revenue for the 2022 fiscal year and is estimating that net income for the year will exceed $1 million.

PLSH settled a contract with XXII that it would exchange the common shares XXII holds and the $500,000 of hemp to reduce the J&N Panacea loan on the building.

F-19

Item 9.Changes in Changes In and Disagreements Withwith Accountants on Accounting and Financial Disclosure.

Disclosure

None.

Item 9A. ControlsControls and Procedures.

(a)Procedures

Evaluation of Disclosure Controls and Procedures

Our management carried out an evaluation, with the participation of our principal executive officer (who currently also serves as our principal financial officer) and our former principal financial officer, have evaluatedrequired by Rule 13a-15 or 15d-15 of the Securities Exchange Act of 1934 (the “Exchange Act”) of the effectiveness of our disclosure controls and procedures as defined in Rules 13a – 15(e) and 15d – 15(e)Rule 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”),Act. Based on their evaluation, our principal executive officer and our former principal financial officer concluded that our disclosure controls and procedures were ineffective as of the end of the period covered by this annual report. We have concludedreport to ensure that based on such evaluation,information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and is accumulated and communicated to our disclosure controlsmanagement, including our principal executive officer and procedures were not effective dueformer principal financial officer, as appropriate to the material weaknesses in our internal control over financial reporting as of December 31, 2016, as further described below. 

(b) allow timely decisions regarding required disclosure.

Management’s Annual Report on Internal Control over Financial Reporting

Overview
Internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) refers to the process designed by, or under the supervision of, our principal executive officer and principal financial officer, and effected by our Board of Directors,

Our management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Management is responsible for establishing and maintaining adequate internal control over financial reporting.

Internal control overreporting (as defined in Rule 13a-15(f) under the Exchange Act). Our management, under the supervision and with the participation of our principal executive officer and principal financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
Management has used the framework set forth in the report entitled “Internal Control — Integrated Framework” published by the Committee of Sponsoring Organizations (“COSO”) of the Treadway Commission to evaluateofficer, evaluated the effectiveness of our internal control over financial reporting. As a resultreporting as of the material weaknesses described below, management has concluded thatend of the Company’speriod covered by this report. Our management’s evaluation of our internal control over financial reporting was not effective asbased on the framework in Internal Control-Integrated Framework (2013), issued by the Committee of December 31, 2016.
Management’s Assessment
Management has determined that, asSponsoring Organizations of the December 31, 2016 measurement date, there were material weaknesses in bothTreadway Commission. In designing and evaluating the disclosure controls and procedures, management recognizes that because of inherent limitations, any controls and procedures, no matter how well designed and operated, may not prevent or detect misstatements and can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and effectivenessprocedures must reflect the fact that there are resource constraints, and that management is required to apply its judgment in evaluating the benefits of ourpossible controls and procedures relative to their costs.

Our internal control over financial reporting. Management has assessed these deficienciesreporting includes those policies and has determinedprocedures that:

pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and

provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

21

Management’s Assessment of the Effectiveness of the Company’s internal Control over Financial Reporting

Our principal executive officer and our former principal financial officer concluded that thereour disclosure controls and procedures were four general categories of material weaknessesnot effective to ensure that the information relating to us is required to be disclosed in internal control over financial reporting. Asour SEC reports (i) is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and (ii) is accumulated and communicated to our management to allow timely decisions regarding required disclosure as a result of our assessment thatthe following material weaknesses in our internal control over financial reporting:

The Company does not have sufficient segregation of duties within accounting functions due to only having two officers and limited resources.
The Company does not have an audit committee; and
The Company does not have written documentation of our internal control policies and procedures.

We plan to rectify these weaknesses by establishing written policies and procedures for our internal control of financial reporting existedand hiring additional accounting personnel at such time as ofwe raise sufficient capital to do so.

Changes in Internal Controls over Financial Reporting

There have been no changes in the internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2016, management has concluded2022, that have materially affected, or is reasonably likely to materially affect, our internal control over financial reporting was not effective as of December 31, 2016. A material weakness in internal controls is a deficiency in internal control, or combination of control deficiencies, that adversely affects the our ability to initiate, authorize, record, process, or report external financial data reliably in accordance with accounting principles generally accepted in the United States of America such that there is more than a remote likelihood that a material misstatement of our annual or interim financial statements that is more than inconsequential will not be prevented or detected. In the course of making our assessment of the effectiveness of internal controls over financial reporting, we identified at least two material weaknesses in our internal control over financial reporting.  Specifically, (1) we lack a sufficient number of employees to properly segregate duties and provide adequate review of the preparation of the financial statements and (2) we lack sufficient independent directors on our Board of Directors to maintain Audit and other committees consistent with proper corporate governance standards. We have limited financial resources and only three employees. The lack of personnel is a weakness because it could lead to improper classification of items and other failures to make the entries and adjustments necessary to comply with U.S. GAAP. Accordingly, management’s assessment is that the Company’s internal controls over financial reporting were not effective as of December 31, 2016.

This Annual Report does not include an attestation report of the Company’s registered accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to rules of the Securities and Exchange Commission.
Changes in Internal Control Over Financial Reporting
No changes in the Company’s internal control over financial reporting have come to management’s attention during the Company’s last fiscal quarter that have materially affected, or are likely to materially affect, the Company’s internal control over financial reporting.

Item 9B. Other Information.

Information

None.

PART III

Item 10. Directors, Executive Officers and Corporate Governance.

Director Information
Governance

The Boardfollowing information sets forth the names, ages, and positions of Directorsour current directors and executive officers as of the CompanyMarch 15, 2023.

NameAgePresent Positions
Leslie Buttorff65CEO and Chairman
Lawrence J. Wert65Director
Nick Cavarra58Senior Vice President Marketing and Sales
Nathan Berman35Controller
James Baumgartner58Chief Science Officer and Quality Control

Directors

Our Board is currently comprised of threetwo (2) members. The following biographical information discloses each director’s age, business experience and other directorships held during the past five years. It also includes the experiences, qualifications, attributes and skills that led to the conclusion that the individual should serve as a director for the Company.

Philip J. Young, age 59, was appointed as our President,director.

Leslie Buttorff is our Chief Executive Officer and Chairman ofdirector since June 30, 2021. Ms. Buttorff has been the Board in March 2016. He was previously appointed as a member of the Board of Directors on February 29, 2016. Mr. Young was a Founder of Exactus BioSolutions and served as its Chairman, President and Chief Executive Officer. He has served as a Director and Executive Officer for public and private companies for the past 20 years where he has created significant shareholder value, built integrated commercial operations and directed successful M&A transactions. From October 2011 through December 2014, he served as President, Chief Executive Officer and Director for AmpliPhi Biosciences, a global biopharmaceutical company, where he completed a transformational restructuring, collaborations and financings. He was the President, Chief Executive Officer and Director of Osteologix, Inc. from April 2007 – March 2011, where he established corporate offices in Ireland after successfully completing a global divestiture of its lead program. Prior to joining Osteologix, Mr. Young served as an Executive Vice President and Chief Business Officer for InsmedPanacea Life Sciences, Inc., a publicly traded biotechnology company where he directed all financing, commercialwhich manufactures and corporate communications activities. Prior to Insmed Inc., Mr. Young held executive positions at Élan, Neurex, and Pharmacia Corporations. Mr. Young started his management career in the biopharmaceutical industry at Genentech Inc. where he was responsible for their cardiovascular and endocrine product launches sales and marketing.

Timothy Ryan, age 56, was appointed as our Executive Vice President in March 2016. He was appointed as a member of our Board of Directors on February 29, 2016. Mr. Ryan was a Founder and Executive Vice President of Exactus BioSolutions. He was the Founder, and for the past seven years, Managing Director, of The Shoreham Group, a Life Sciences Advisory and Investor Relations firm.develops pharma-grade hemp-related products since 2017. In 2012, Mr. Ryan led the successful leveraged buy-out of Merrill Industries, a manufacturer and distributor of packaging products. He currently serves on its board of directors. For the five years preceding Shoreham’s formation in 2008, he was a Senior Vice President of the Trout Group, a Life Sciences Advisory and Investor Relations firm. Prior to that, he wasaddition, Ms. Buttorff has been the Chairman of the Board of Stracq,Quintel-MC, Inc., an acquisition vehicle where he led a company that focuses on SAP ERP (Enterprise Resource Planning) implementations since 2002. Ms. Buttorff formed Quintel-MC, Inc. in 2002. Before establishing Quintel, Ms. Buttorff was the successful buyout ofglobal practice leader for Arthur D. Little’s Utilities and Energy practice and was responsible for the alliance with Perot Systems. Ms. Buttorff is also a healthcare ingredient company, Stryka Botanics, from Chapter 11 bankruptcy. On Wall Street, he has been an Investment Banker and Head of Capital Markets where he managed both public offerings and private placements. He also ran a syndicate department and managed Institutional and Retail sales teams. Mr. Ryan was a Senior Vice President of Lehman Brothers and a Principalmember of the Hambrecht & Quist Group. He is a graduateBoards of Boston College.
Krassen Dimitrov,age 48,Active Youth Network (provides revenue and enables information for sports teams, high schools and clubs) and JobZology (a CSU spinoff focused on matching people and jobs for employers). Ms. Buttorff was appointed to serveour Board as a result of her knowledge of the business, ownership and position with the Company.

Lawrence J. Wert was appointed to our Board on April 29, 2020. Mr. Wert has over 40 years in broadcasting. Mr. Wert served as the President of Broadcast Media for Tribune Media Company from 2013 through September of 2019. Mr. Wert previously served on the NAB TV Board of Directors, Fox Board and the CBS Board of Governors. In 2017, Mr. Wert was named “Broadcaster of the Year” by the Illinois Broadcaster’s Association. Currently, he serves on the Board of Directors for several charities, including the Children’s Brittle Bone Foundation, Catholic Charities, the Chicagoland Chamber of Commerce and the 100 Club. Mr. Wert is a member of ourthe Governing Board of Directors in March 2016. Dr. Dimitrov isGilda’s Club of Chicago, an advisor to the FounderChicago Chapter of Make-A-Wish Foundation and Managing Directoran honorary board member of Digital Diagnostics, Pty. Ltd – a spinout startup company fromRAINBOWS, an organization that helps children cope with loss. In 2018, Mr. Wert was inducted into the Australian Institute for Bioengineering and Nanotechnology (AIBN) where Dr. Dimitrov was a Group Leader from 2006 until 2012. Prior to AIBN, he was the Founder and CTOChicago Catholic League Hall of NanoString Technologies (NASDAQ: NSTG) in Seattle (2003-2006), a company he founded to commercialize his invention of fluorescent nanobarcodes for single molecules. Prior to NanoString, Dr. Dimitrov was the Director of the DNA Microarray Laboratory at the Institute for Systems Biology in Seattle (2000-2003), and played a significant role in the formation and early growth of the Institute. During his research career Dr. Dimitrov has made many significant research discoveries. Most importantly he invented and pioneered the barcodes for single-molecule detection, which are currently marketed by NanoString Technologies. More recently Dr. Dimitrov invented and developed products for rapid and sensitive detection of proteolytic activities with handheld electronic devices. These products are currently in the process of clinical testing and commercialization by Exactus, Inc. (OTC: EXDI) and will find applications in detection of fibrinolysis and metastatic degradation of extracellular matrices. Dr. Dimitrov holds a Ph.D. in Biochemistry from Baylor College of Medicine, and M.Sc. in Biotechnology from Sofia University. Dr. Dimitrov is invaluable to ourFame. Mr. Wert also sits on Board of DirectorsTrustees for Fenwick High School in Oak Park, Ill. Mr. Wert was appointed as a recognized leader in the fielddirector as a result of diagnostics and nanotechnology and as the primary developer of the technology upon which our products are dependent.

his prior experience with Exactus, Inc.

Executive Officers Who Are Not Directors

The following provides certain biographical information with respect to each executive officer of the Company who is not a director.

See “Directors” above for Ms. Buttorff’s biographical information.

Nick Cavarra is our President of the Company since 2019. Mr. Cavarra brings over 25 years of management, leadership and sales experience at the local and national level in the broadcast/digital media, software and web/mobile development marketplace. His previous career positions include C-Level management experience with AYN and Zapotech Inc., and senior account management positions at KUSA-TV and KMGH-TV.

22

Nathan Berman is our Controller since June 30, 2021. Mr. Berman works as the controller for Panacea Life Sciences since December 2019. Prior to Panacea, Mr. Berman worked for Quintel-MC, Inc, and Media Audits International providing audit and management services on behalf of large broadcast corporations. Prior to this, Mr. Berman began his career in the banking industry while pursuing his CFA designation through the CFA Institute.

James R. Erickson, Ph.D., age 54, was appointed as“Jamie” W. Baumgartner is our Chief BusinessScience Officer on December 1, 2016, effective December 5, 2016. Priorand Quality Control since 2017. Mr. Baumgartner has recently lead two science-based businesses resulting in marked increases in revenue, productivity and profitability. Mr. Baumgartner adds over 20 years of drug discovery experience to joining Exactus, Dr. Erickson served as a Senior Transaction Advisor at Ferghana Partners, a healthcare investment bank focusing on financings, M&APLS and corporate partneringreinforces the company’s commitment to its foundation in scientific research and development in the diagnostichealthcare and therapeutic sectors,biotech industries.

Employees and Contractual Arrangements

As of January 1, 2018, we employ management and support staff, chemists, extraction specialists, lab technicians order fulfillment and sales executives. We are building our culture around a position he held since October 2013. Previously, Dr. Erickson served as Chief Executive Officer of BayPoint Biosystems, Inc., a proteomic company focusedperformance-based system, and unlike other CBD companies we offer our employees personal time off (PTO) and health and dental benefits. We believe this is important in order to attract the best individuals for these roles. We also have an outsourcing agreement with Canna Software, LLC (ERPCannabis solution based on commercializing diagnostics/research tools-oriented technology fromSAP) to provide back-office operations assistance in the M.D. Anderson Cancer Center, from December 2005 to August 2013.

Kelley A. Wendt, age 43, was appointed as our Chief Financial Officerfinancial, human resources, procurement and Treasurerpayroll and tax areas. We also have under contract ten sales territory managers that have many sales reps reporting in January 2016. From December 2011 through September 2014, Ms. Wendt served as the Chief Financial Officer and consultant for Ampliphi BioSciences Corporation, a global biopharmaceutical company. Prior to joining AmpliPhi, she served as the Chief Financial Officer for Osteologix, Inc. Prior to joining Osteologix, Ms. Wendt served as the Chief Financial Officer for Crop Life America, a global chemical industry trade organization, from 2006 to 2008. She is the former Controller for Sheltering Arms Hospitals, a rehabilitation hospital company with nine facilities across the Richmond, Virginia region. Her pre-executive experience consists of several regional and national public accounting firms, primarily in audit and consulting roles. Ms. Wendt received a B.S. in business and accounting from Wright State University.
No each sales territory. Overall, we currently has over 20 individuals working under PLS.

Family Relationships

There are no family relationships between or among the directors. There are family relationships between our CEO, brother and niece.

Involvement in Certain Legal Proceedings

To the best of our knowledge, during the past ten years, none of the following occurred with respect to a present or former director, executive officer, or employee: (1) any directorsbankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time; (2) any conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and executive officers.

Codeother minor offenses); (3) being subject to any order, judgment or decree, not subsequently reversed, suspended vacated, of Ethics
Dueany court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending or otherwise limiting his or her involvement in any type of business, securities or banking activities; and (4) being found by a court of competent jurisdiction (in a civil action), the SEC or the Commodities Futures Trading Commission to changehave violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended or vacated.

Audit Committee Financial Expert

Leslie Buttorff serves as the chairman of controlthe audit committee. CFO Squad was previously retained to assist with the audit and business focus, we currently do not have a Code of Ethics.SEC filings and provide other accounting advice. Our Board has determined that Leslie Buttorff is reviewing a Codequalified as an “audit committee financial expert”, as that term is defined under the rules of Ethics that applies to our Chief Executive Officerthe SEC and our Chief Financial Officer as well as to our other senior management. This Code of Ethics will complyin compliance with the requirements imposed by the Sarbanes-Oxley Act of 2002, as amended,2002.

Code of Ethics

On January 9, 2019, our Board adopted a Code of Business Conduct and the rules and regulations issued thereunder for codes of ethicsEthics applicable to such officers. When the Code of Ethics is final, it will be available onall our website, located at http://www.exactusinc.com

Audit Committee
Due to the limited size of our Board of Directors, the entire Board acts as the audit committee.
Audit Committee Financial Expert
Due to the limited size of our Board of Directors, we do not have a financial expert on the audit committee. We will be expanding our Board in the near future to include a financial expert.
directors, executive officers, and employees.

Item 11. Executive Compensation.

The following table sets forth certain information aboutCompensation

Compensation Discussion and Analysis

With regard to our full-time executive officer, the goal of the salary component of our compensation policy is to provide reasonable compensation for their full-time service within the constraints faced by a rapidly developing business with significant cash needs for its planned expansion. Equity grants for our full-time executive officers are currently under review by the compensation paid or accruedcommittee. The goal of our anticipated equity grants will be to the persons who servedprovide an appropriate mixture of short term and long-term incentives to increase shareholder value.

On December 31, 2021, we entered into an updated Employment Agreement with Leslie Buttorff pursuant to which Ms. Buttorff serves as our Chief Executive Officer and our two highest-paid executive officers during the last two completed fiscal years whose total compensation exceeded $100,000 for that yearan initial term of July 1, 2021, to December 31, 2024 (the “named executive officers”)“Employment Agreement).

Summary Compensation Table
 Year
 
Salary
 
 
Bonus
 
 
Non-Equity Incentive Plan Compensation(1)
 
 
All Other Compensation
 
 
Total
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Philip J. Young2016
 $297,917 
 $-- 
 $-- 
 $-- 
 $297,917 
President and Chief Executive Officer 
    
    
    
    
    
 
    
    
    
    
    
Timothy Ryan2016
 $110,000 
 $-- 
 $-- 
 $-- 
 $110,000 
Executive Vice President 
    
    
    
    
    
______________
(1) Pursuant to our employment agreements with Mr. Young and Mr. Ryan, we have agreed to grant stock options to these officers as described under “—Employment Agreements” below. We anticipate that our Board of Directors will determine the amount of these awards and grant these stock options following adoption of our Stock Option Plan in the first quarter of 2017.
Employment Agreements and Change in Control Arrangements
Under her Employment Agreement, with Philip J. Young. Effective December 15, 2015, we entered intoMs. Buttorff receives an employment agreement with Mr. Young pursuantannual base salary of $380,000. To date, Ms. Buttorff has not taken a salary and payments have accrued commencing in January 2021.

Ms. Buttorff is also entitled to which he will serve asreceive (i) a sales commission of 2% of revenue from sales generated by Ms. Buttorff after revenue exceeds $500,000 for three consecutive months, (ii) an award of $2.2 million of shares of common stock upon approval of our President and Chief Executive Officer. Under the termscommon stock for listing on The Nasdaq Capital Market prior to expiration of the employment agreement, Mr. Young will receive a base salary atterm of the Employment Agreement, and (iii) an initial rate of $390,000 per year. For a limited period until we have raised at least $5 million of capital, he will receive a reduced salary of $325,000 per year. Within 30 days after we raise at least $5 million of capital, Mr. Young will receive, as a lump sum bonus payable inannual cash or stock at our discretion, the amount equal to the difference between the amount he would have been paid at his initial rate of $390,000 and the amount he was paid at the reduced salary level. In addition, Mr. Young will have the opportunity to earn an annual performance bonus of up to 75%100% of hisher base salary based on the achievement of performance criteriametrics for the applicable fiscal year to be set by our Board of Directors. Also, pursuant to the employment agreement, we agreed to grant stock options to Mr. Young to purchase shares of our common stock at an exercise price equal to the fair market value of our common stock on the date of grant as reasonably determined by our BoardBoard.

23

Director Compensation

Compensation of Directors in good faith. Pursuant toTable

The following table shows the agreement, 50% ofcompensation paid during the options were to vest onyear ended December 31, 20162022 to our non-employee director.

Name    Stock Awards (No.)  Option Awards (No.)  Fees Earned or Paid in Cash ($)  Non-Equity Incentive Plan Compensation ($)  Non-Qualified Deferred Compensation Earnings ($)  All Other Compensation ($)  Total ($) 
                         
Leslie Buttorff  (a)     0   0   0   0   0   380,000   380,000 
Executive Chairman                                
Lawrence J. Wert  (b)     0   0   0   0   0   0   0 
Board Member                                

(a) Compensation is deferred.

Equity Awards At Year End

None.

Option Exercises and the other 50% will vest ratably over a thirty-six month period beginning in January 2017. Mr. Young also is entitled to an automobile allowance of $1,500 per month, disability insurance coverage equal to his base salary, life insurance with a $2 million death benefit, reimbursement of certain expenses, health, dental and vision coverage in accordance with our usual practices and participation in all other benefit plans maintained by the Company.

Mr. Young’s employment agreement may be terminated by us atStock Vested

Our named executive officers did not exercise any time for “Cause” (as defined in his employment agreement) and by Mr. Young upon 14 days’ prior written notice, or upon Mr. Young’s death or disability. The employment agreement also provides for termination of Mr. Young’s employment by us without Cause or by Mr. Young for “Changed Circumstances” (as defined in his employment agreement).

If Mr. Young’s employment is terminated by us without Cause or by him for Changed Circumstances, and provided that Mr. Young releases and waives his claims against the Company as provided in the employment agreement, he is entitled to receive (i) monthly severance payments and continuation of benefits for a period equal to the greater of (A) 6 months or (B) the number of months between December 15, 2015 and his termination, up to a maximum of twelve months, (ii) accelerated vesting of equitystock option awards as if his employment had continued during such period and (iii) a pro rata portion of any eligible bonus compensation. If Mr. Young’s employment is terminated by us (with or without Cause) or by him for Changed Circumstances in connection with or following a “Change in Control” (as defined in his employment agreement), he will be entitled to receive the benefits in the preceding sentence as if his employment were terminated more than twelve months after December 15, 2015, plus the pro rata portion of any eligible bonus compensation.
Mr. Young’s employment agreement also contains restrictive covenants relating to the protection of confidential information, non-competition and non-solicitation. The non-solicitation and non-competition covenants apply during the term of his employment and continue generally for a period of 12 months following the termination of his employment. Mr. Young will not be entitled to any severance or change in control benefits under his employment agreement if he breaches any of these covenants.
Employment Agreement with Timothy Ryan. Effective December 15, 2015, we entered into an employment agreement with Mr. Ryan pursuant to which he will serve as our Executive Vice President. Under the terms of the employment agreement, Mr. Ryan will receive a base salary at an initial rate of $240,000 per year. For a limited period until we have raised at least $5 million of capital, he will receive a reduced salary of $120,000 per year. Within 30 days after we raise at least $5 million of capital, Mr. Ryan will receive, as a lump sum bonus payable in cash or stock at our discretion, the amount equal to the difference between the amount he would have been paid at his initial rate of $240,000 and the amount he was paid at the reduced salary level. In addition, Mr. Ryan will have the opportunity to earn an annual performance bonus of up to 50% of his base salary based on performance criteria set by our President and Chief Executive Officer. Also pursuant to the employment agreement, we agreed to grant stock options to Mr. Ryan to purchase shares of our common stock at an exercise price equal to the fair market value of our common stock on the date of grant as reasonably determined by our Board of Directors in good faith. Pursuant to the agreement, 50% of the options were to vest onyear ended December 31, 2016 and the other 50% will vest ratably over a thirty-six month period beginning in January 2017. Mr. Ryan also is entitled to an automobile allowance of $1,250 per month, disability insurance coverage equal to his base salary, life insurance with a $1 million death benefit, reimbursement of certain expenses, health, dental and vision coverage in accordance with our usual practices and participation in all other benefit plans maintained by the Company.
Mr. Ryan’s employment agreement may be terminated by us at any time for “Cause” (as defined in his employment agreement) and by Mr. Ryan upon 14 days’ prior written notice, or upon Mr. Ryan’s death or disability. The employment agreement also provides for termination of Mr. Ryan’s employment by us without Cause or by Mr. Ryan for “Changed Circumstances” (as defined in his employment agreement).
If Mr. Ryan’s employment is terminated by us without Cause or by him for Changed Circumstances, and provided that Mr. Ryan releases and waives his claims against the Company as provided in the employment agreement, he is entitled to receive (i) monthly severance payments and continuation of benefits for a period equal to the greater of (A) 6 months or (B) the number of months between December 15, 2015 and his termination, up to a maximum of twelve months, (ii) accelerated vesting of equity awards as if his employment had continued during such period and (iii) a pro rata portion of any eligible bonus compensation. If Mr. Ryan’s employment is terminated by us (with or without Cause) or by him for Changed Circumstances in connection with or following a “Change in Control” (as defined in his employment agreement), he will be entitled to receive the benefits in the preceding sentence as if his employment were terminated more than twelve months after December 15, 2015, plus the pro rata portion of any eligible bonus compensation.
Mr. Ryan’s employment agreement also contains restrictive covenants relating to the protection of confidential information, non-competition and non-solicitation. The non-solicitation and non-competition covenants apply during the term of his employment and continue generally for a period of 12 months following the termination of his employment. Mr. Ryan will not be entitled to any severance or change in control benefits under his employment agreement if he breaches any of these covenants.
Employment Agreement with James R. Erickson, Ph.D. On December 1, 2016, we entered into an employment agreement with Dr. Erickson, dated December 1, 2016 (the “Employment Agreement”), which provides for his service as Chief Business Officer of the Company. Dr. Erickson’s employment will continue until it is otherwise terminated by either party pursuant to the terms of the Employment Agreement. The Employment Agreement may be terminated by us without “Cause” upon three months’ advance written notice, or for “Cause”, and by Dr. Erickson without “Good Reason” or for “Good Reason” (as those terms are defined in the Employment Agreement).
Dr. Erickson will receive an initial limited annual base salary of $125,000 (the “Limited Salary”) from December 5, 2016 until we have brought in an aggregate of $5 million in financing, whether through the sale of securities or otherwise (the “Limited Salary Period”). At the conclusion of the Limited Salary Period, Dr. Erickson will receive an annual base salary of $250,000 (the “Base Salary”). Dr. Erickson is eligible to earn an annual performance bonus equal to up to 55% of his Limited Salary or Base Salary, based upon performance criteria set by the Board of Directors in its sole discretion on an annual basis. The agreement provides for the grant of stock options for 1,000,000 shares of our common stock, half of which will vest on December 31, 2017, or immediately upon the establishment of a stock option plan in 2017. The other half will vest monthly on the first day of each subsequent month, commencing January 1, 2018, at a rate of 1/36 of the total number of remaining shares per month. Pursuant to the terms of the Employment Agreement, vesting will be accelerated following a termination or Change in Control (as defined in the Employment Agreement). Dr. Erickson will be entitled to participate in all employee benefit plans for which he is eligible, including health and dental insurance, life and disability insurance, and all other employee benefit plans effected for our employees generally pursuant to the Employment Agreement.
If we terminate Dr. Erickson’s employment for Cause, as provided by the Employment Agreement, he will be entitled to receive the Initial Salary or Base Salary or bonus earned and unpaid through the date of termination. In the event we terminate Dr. Erickson’s employment without Cause or Dr. Erickson terminates his employment for Good Reason, as provided in the Employment Agreement, Dr. Erickson will be entitled to receive (i) a payment in the amount of his Base Salary or Limited Salary (whichever is applicable) for the greater of six months or the number of full months between December 5, 2016 and date of termination up to a maximum of twelve months (the “Severance Period”), (ii) continuation of his benefits (to the extent authorized by COBRA) on a monthly basis for the Severance Period; and (iii) accelerated vesting of any stock options subject to vesting with respect to the number of shares that would have vested during the Severance Period if Dr. Erickson had remained employed by us during such time. In the event that we terminate Dr. Erickson’s employment without Cause, or by the Executive for Good Reason, within six months following a Change in Control of the Company, pursuant to the terms of the Employment Agreement, Dr. Erickson will be entitled to receive (i) payment in the amount of his Base Salary or Limited Salary (whichever is applicable) for twelve months, (ii) continuation of his benefits for twelve months (to the extent authorized by and consistent with COBRA), (iii) accelerated vesting of any stock options subject to vesting with respect to the number of shares that would have vested during the Severance Period if Dr. Erickson had remained employed by us during such time, and (iv) any pro-rated bonus portions which the Board of Directors, at its sole discretion, determines had been earned by Dr. Erickson, which will be in lieu of any benefits to which Dr. Erickson is otherwise entitled.
Dr. Erickson’s agreement also includes covenants relating to non-disclosure of confidential information and non-competition, non-solicitation, non-interference with customers, and non-hiring of employees for a period of one year following termination of employment.
Employment Agreement with Kelley Wendt. Effective March 16, 2017, we entered into an employment agreement with Kelley Wendt which provides for her continued services as the Chief Financial Officer of the Company. The initial term of the employment agreement will end on February 1, 2019 and will automatically renew for successive one (1) year terms, unless either we provide to Ms. Wendt, or Ms. Wendt provides to us, written notice of nonrenewal at least thirty (30) days prior to the expiration of the then current term. The employment agreement may be immediately terminated by us for “Cause” (as defined in her employment agreement) or by us or Ms. Wendt upon two (2) months’ advance written notice.
Ms. Wendt will receive an initial annual gross base salary of $90,000 (the “Annual Base Salary”) and is eligible to earn an annual performance bonus equal to up to 60% of her Annual Base Salary (the “Performance Bonus”) based upon performance criteria established by the Company from time to time. She also is eligible to participate in the Company’s stock incentive plan. Ms. Wendt will be entitled to receive up to twenty-five (25) days paid vacation each year and to participate in all employee health and welfare benefits plans for which she is eligible.
The employment agreement also includes covenants relating to non-disclosure of confidential information and non-competition, non-solicitation of customers, and non-solicitation and non-hiring of employees for a period of one year following termination of employment.
Stock Option Plan
We anticipate adopting a Stock Option Plan in the first quarter of 2017, pursuant to which our Board of Directors may grant stock options to employees, directors and consultants from time to time. Pursuant to our employment agreements with Mr. Young and Mr. Ryan, we have agreed to grant stock options to these officers as described under “—Employment Agreements” above. We anticipate that our Board of Directors will determine the amount of these awards and grant these stock options following adoption of our Stock Option Plan.
As of December 31, 2016, we did not have any compensation plans under which shares of our common stock were authorized for issuance, nor did we have any stock options outstanding.
Director Compensation
Our directors currently do not receive any compensation for their service as members of our Board of Directors.
2022.

Item 12. Security Ownership of Certain Beneficial Owners and ManagementManagement and Related StockholderMatters.

Stockholder Matters

The following table sets forth information as of December 31, 2016,2022, regarding the number of shares of our common stock beneficially owned by each director, each named executive officer and by all directors and executive officers as a group. Beneficial ownership includes shares, if any, held in the name of the spouse, minor children or other relatives of the director or executive officer living in such person’s home, as well as shares, if any, held in the name of another person under an arrangement whereby the director or executive officer can vest title in himself at once or at some future time. Unless otherwise noted, each shareholder’s address is 4870 Sadler Road,5910 S. University Blvd, Suite 300, Glen Allen, VA 23060,C18-193, Greenwood Village, CO 80121, and each shareholder has sole voting power and investment power with respect to securities shown in the table below.

Title of class Name of beneficial owner Amount and Nature of Beneficial Ownership (1)  Percent of Class (1) 
Named Executive Officers:        
         
Common Stock Leslie Buttorff (2)  4,646,953   31.5%
           
Common Stock Nathan Berman (3)  17,749     *   
           
Directors:          
           
Common Stock Lawrence J. Wert (4)  307,868   2.1%
           
Common Stock All directors and executive officers as a group (4 persons) (5)  5,043,564   31.5%
           
5% Stockholders:          
Common Stock Quintel-MC Incorporated (7)  4,047,054   27.4%
Common Stock 22nd Century Group Inc. (8)    3,250,573   22.0%

(1)

Applicable percentages are based on 14,762,342 of common stock outstanding as of the March 15, 2022, excluding securities held by or for the account of the Company. Beneficial ownership is determined under the rules of the SEC and generally includes voting or investment power with respect to securities. A person is deemed to be the beneficial owner of securities that can be acquired by such person within 60 days after March 31, 2022, whether upon the exercise of options, warrants or conversion of notes. Unless otherwise indicated in the footnotes to this table, we believe that each of the stockholders named in the table has sole voting and investment power with respect to the shares of common stock indicated as beneficially owned by them. This table does not include any unvested stock options except for those vesting within 60 days.
(2)Ms. Buttorff is our Chief Executive Officer, Chief Financial Officer and director. Includes 4,047,054 shares of common stock held by Quintel-MC Incorporated. Ms. Buttorff is the President of Quintel-MC, Incorporated.
(3)Mr. Berman is our Controller.
(4)Mr. Wert is a director.
(5)Directors and Executive Officers as a group. This amount includes ownership by all directors and all current executive officers including those who are not Named Executive Officers under the SEC’s disclosure rules.
(6)Quintel-MC Incorporated. Ms. Buttorff was the President of Quintel-MC Incorporated. Address is 5910 South University Suite C18-193, Greenwood Village, CO 80121. Quintel was sold and is in the process of closure.
(8)22nd Century Group Inc. Based on Schedule 13G filed on July 9, 2021. Address is 500 Seneca Street, Suite 507, Buffalo NY 14204.

Title of Class
 
Name of Beneficial Owner
 
Amount and Nature of
Beneficial Ownership
 
Percent ofClass (1)
 
 
 
 
 
 
 
 
 
 
 
Common Stock
 
Philip J. Young
 
  8,668,000(2)
 
  25.3%
Common Stock
 
Kelley A. Wendt
 
  600,000(3)
 
  1.7%
Common Stock
 
Timothy Ryan
 
  8,618,000(4)
 
  25.2%
Common Stock
 
James R. Erickson
 
  1,600,000 
 
  4.7%
Common Stock
 
Krassen Dimitrov
 
  3,600,000(5)
 
  10.6%
Directors and executive officers as a group (5 individuals) 
 
  23,086,000 
 
  65.9%
_________________
(1)
Based on 34,071,862 shares of our common stock outstanding as of December 31, 2016.
(2)
Includes 168,000 shares of common stock issuable upon the conversion of shares of Series B-2 Preferred Stock at a rate of one share of common stock for each share of Series B-2 Preferred Stock.
(3)
Includes 600,000 shares of common stock issuable upon the conversion of shares of Series B-1 Preferred Stock at a rate of one share of common stock for each share of Series B-1 Preferred Stock.
(4)
Includes (i) 2,950,000 shares of common stock held by Willets Capital over which Mr. Ryan has sole voting power and investment power, (ii) 2,850,000 shares of common stock held by Tonset Capital, over which Mr. Ryan has sole voting power and investment power, (iii) 400,000 shares of common stock held by NYTX LLC, over which Mr. Ryan has sole voting power and investment power, (iv) 300,000 shares of common stock held by Brosis LLC, over which Mr. Ryan has sole voting power and investment power and (v) 168,000 shares of common stock issuable upon the conversion of shares of Series B-2 Preferred Stock at a rate of one share of common stock for each share of Series B-2 Preferred Stock held directly by Mr. Ryan.
(5)
Includes 3,600,000 shares of common stock held by Digital Diagnostics, Inc., of which Dr. Dimitrov is President and 78% owner.
The following table sets forth information, as of December 31, 2016, regarding the number of shares of our common stock beneficially owned by all persons known by us, other than those set forth in the table above, who own five percent or more of our outstanding shares of common stock.
24
 Title of Class
Name and Address of Beneficial Owner
Amount and Nature of Beneficial Ownership
Percent ofClass (1)
Common Stock
MagniSciFund, LP
123 N Post Oak Lane, Suite 400
Houston, TX 77024
6,000,000 (2)
15.0%
Common Stock
PoC Capital LLC
2995 Woodside Avenue, Suite 400-121
Woodside, CA 94062
3,400,001 (3)
9.1%
Common Stock
Sandor Capital Master Fund
2828 Routh Street, Suite 500
Dallas, TX 75201-1438
2,300,000 (4)
6.5%
Common Stock
Velocity Health Capital
95 White Bridge Road, Suite 509
Nashville, TN 37205
2,068,000 (5)
6.0%
_________________
(1)
Based on 34,071,862 shares of our common stock outstanding as of December 31, 2016.
(2)
Includes 6,000,000 shares of common stock issuable upon the conversion of shares of Series B-2 Preferred Stock at a rate of one share of common stock for each share of Series B-2 Preferred Stock.
(3)
Includes 1,733,334 shares of common stock issuable upon the conversion of shares of Series C Preferred Stock at a rate of one share of common stock for each share of Series C Preferred Stock and 1,666,667 shares of common stock issuable upon exercise of outstanding warrants.
(4)
Includes 300,000 shares of common stock issuable upon the conversion of shares of Series B-1 Preferred Stock at a rate of one share of common stock for each share of Series B-1 Preferred Stock and 900,000 shares of common stock issuable upon the conversion of shares of Series B-2 Preferred Stock at a rate of one share of common stock for each share of Series B-2 Preferred Stock.
(5)
Includes 168,000 shares of common stock issuable upon the conversion of shares of Series B-2 Preferred Stock at a rate of one share of common stock for each share of Series B-2 Preferred Stock.

Item 13. Certain Relationships and Related Transactions, and Director Independence.

We currently have a consulting arrangement with Dr. Krassen Dimitrov, a director and shareholder ofIndependence

Our CEO is the Company. In February 2016, we entered into a consulting agreement with Dr. Dimitrov pursuant to which we retained KD Innovations Ltd., a company fully owned by him (“KD Innovations”), for a fee of $25,000 per month during the term of the arrangement, to manage the design and production of our lead device, FibriLyzer, and provide scientific expertise. For the year 2016, we recognized $250,000 in research and development expenses in connection with these consulting services. The consulting agreement does not have a fixed term; however, it may be terminated with immediate effect at any time upon mutual agreement between us and KD Innovations, or by either party with 90-days written notice to the other party.

In addition, Dr. Dimitrov is President and a 78% owner of Digital Diagnostics, Inc., with whom we have entered intorelated parties J&N Real Estate LLC. J&N is a major shareholder and holds a note of Panacea and is the Licensing Agreement. The Licensing Agreement providesleaseholder for Exactus BioSolutions and Digital Diagnostics to collaborate through the various steps of the product and device development process, including the development, regulatory approval and commercialization stages. Exactus BioSolutions is required to pay Digital Diagnostics,laboratory in cash and/or stock, an initial signing payment, milestone fees triggered by the first regulatory clearance or approval of each of FibriLyzer and MatriLyzer, and various sales thresholds, and royalty payments based on the net sales of the products, calculated on a product-by-product basis. The initial signing payment is due within seven days of the effective date of the agreement, with the remaining amount due upon closing of certain of our financing transactions. In 2016, we paid $50,000 to Digital Diagnostics as part of the initial signing payment under the Licensing Agreement and $21,659 in legal expenses. As of December 31, 2016, we accrued an additional $171,033 in licensing fees due to closing a financing transaction in the fourth quarter of 2016. No milestones have been met and no milestone fees have been paid or accruedGolden. See Note 6: Notes for through December 31, 2016.
Related Party Transactions.

Director Independence

Our Board of Directors currently consists of three directors: Philip J. Young, Timothy Ryan and Krassen Dimitrov, none of whom would be considered “independent”

We are not a “listed issuer” within the meaning of NASDAQItem 407 of Regulation S-K and there are no applicable listing standards.

standards for determining the independence of our directors. Applying the definition of independence set forth in Rule 4200(a)(15) of The Nasdaq Stock Market, Inc., we believe that Larry Wert is an independent director.

Item 14. Principal AccountingAccountant Fees and Services.

Audit Fees
Services

The following table presents the aggregate fees billed for each of the last two fiscal years by our principal accountant forindependent registered public accounting firm, Borgers, in connection with the audit of our annualconsolidated financial statements review of financial statements included in the quarterly reports and other fees that are normally provided byprofessional services rendered.

Year Ended: Audit Services Tax Fees Other Fees
December 31, 2022 $110,000 n/a n/a
December 31, 2021 $25,000 n/a n/a

The following table presents the accountant in connection with statutory and regulatory filings or engagements for the year ended December 31, 2016 and 2015 was $58,000 and $42,000, respectively. 

Audit-Related Fees
The aggregate fees billed by our principal accountant for assurance and advisory services that were related to the performance of the audit or review of our financial statements for the year ended December 31, 2016 and 2015 was $0.00 each year. 
Tax Fees
            The aggregate fees billed for each of the last two fiscal years by our independent registered public accounting firm, RBSM LLP, in connection with the audit of our consolidated financial statements and other professional services renderedrendered.

Year Ended: Audit Services Tax Fees Other Fees
December 31, 2022 $- n/a n/a
December 31, 2021 $165,000 n/a n/a

Pre–Approval Policy of Services Performed by our principal accountant for tax compliance, tax advice and tax planning for the years ended December 31, 2016 and 2015 was $0 each year. These fees related to the preparation of federal income and state franchise tax returns.

All Other Fees
Independent Registered Public Accounting Firm

The aggregate fees billed for products and services provided by someone other than our principal accountant for the fiscal year ended December 31, 2016 and 2015 was $0 each year.

Policy on Audit
We do not currently have an Audit Committee.  TheBoard policy of our Board of Directors, which acts as our Audit Committee, is to pre-approvepre–approve all audit and permissible non-audit services provided by the independent auditors. These services may include non–audit services, audit-relatedrelated services, tax services and other services. Pre-approval is generally provided for up to one year and any pre-approval is detailed as to the particular service or category of services and is generally subject to a specific budget. The independent auditorsregistered public accounting firm and management are required to periodically report to our Board of Directorsthe full Audit Committee regarding the extent of services provided by the independent auditorsregistered public accounting firm in accordance with this pre-approval,pre–approval and the fees for the services performed to date. The Board of Directors may also pre-approve particular services on a case-by-case basis. 

25

PART IV

Item 15. Exhibits, Financial Statement Schedules.

Statements Schedules

(a) Financial Statements and Schedules

The following financial statements and schedules listed below are included in this Form 10-K.

Financial Statements (See Item 8)

    Incorporated by Reference 

Filed or

Furnished

Exhibit # Exhibit Description Form Date Number Herewith
3.1 Amended Articles of Incorporation 8-K 7/7/21 3.1  
3.1(a) Certificate of Amendment to its Amended and Restated Articles of Incorporation – name change and reverse stock split 8-K 10/29/21 3.1  
3.2 Amended and Restated Bylaws       Filed
3.3 Certificate of Designation for Series A Preferred Stock 8-K 2/18/21 4.1  
3.4 Certificate of Designation for Series B-1 Preferred Stock 8-K 3/4/16 3.1  
3.5 Certificate of Designation for Series B-2 Preferred Stock 8-K/A 2/17/16 3.2  
3.6 Certificate of Designation for Series C Preferred Stock 10-Q 8/23/21 3.7  
3.7 Certificate of Designation for Series C-1 Preferred Stock 10-Q 8/23/21 3.8  
3.8 Certificate of Designation for Series C-2 Preferred Stock 8-K 10/29/21 3.2  
3.9 Certificate of Designation for Series D Preferred Stock 10-Q 8/23/21 3.9  
3.10 Certificate of Withdrawal for Series A 10-Q 4/29/22 3.10  
4.1 Description of securities registered under Section 12 of the Exchange Act of 1934       Filed
10.1 Agreement (redacted) with Dr. Krassen Dimitrov, Digital Diagnostic, Inc. and KD Innovation, Ltd.+ 8-K 1/27/21 10.2  
10.2 Securities Purchase Agreement (redacted)+ 8-K 2/18/21 10.1  
10.3 Exchange Agreement 8-K 2/18/21 10.2  
10.5 Settlement and Release Agreement with Creed2Med, LLC 10-K/A 4/23/21 10.6  
10.6 Supply Agreement 10-K 4/15/21 10.3  
10.7 Note and Loan Agreement 8-K 4/26/21 10.1  
10.8 Form of Securities Exchange Agreement 8-K 7/7/21 10.1  
10.9 Form of Indemnification Agreement* 8-K 7/7/21 10.2  
10.10 Employment Agreement dated June 30, 2021 – Leslie Buttorff* 10-Q 8/23/21 10.2  
10.11 Form of Promissory Note issued to Quintel-MC Incorporated (Panacea) 10-Q 8/23/21 10.5  
10.12 Form of Promissory Note issued to Leslie Buttorff (Panacea) 10-Q 8/23/21 10.6  
10.13 Form of Promissory Note issued to Leslie Buttorff (Exactus) 10-Q 8/23/21 10.7  
10.14 Note Exchange Agreement+** 10-Q 8/23/21 10.8  
10.15 Assignment of lease 10-Q 8/23/21 10.9  
10.16 Form of Securities Purchase Agreement** 8-K 11/24/21 10.1  
10.17 Form of Original Issue Discount Senior Convertible Promissory Note 8-K 11/24/21 10.2  
10.18 Form of Warrant 8-K 11/24/21 10.3  
10.19 Form of Registration Rights Agreement** 8-K 11/24/21 10.4  
10.20 Amended and Restated 2021 Equity Incentive Plan*       Filed
16.1 Letter from RBSM LLP, dated December 28, 2021 8-K 12/29/21 16.1  
23.1 Consent of BF Borgers CPA PC       Filed
31.1 Certification of Principal Executive Officer and Principal Financial Officer (302)       Filed
32.1 Certification of Principal Executive and Principal Financial Officer (906)       Furnished***
101.INS Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document        
101.SCH Inline XBRL Taxonomy Extension Schema Document       Filed
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document       Filed
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document       Filed
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document       Filed
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document       Filed
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)        
 1.
Documents filed as part of this report:
 1.Financial Statements.  Reference is made to the Index to the Consolidated Financial Statements set forth under Part II, Item 8, on page 22 of this Form 10-K.
 2.Financial Statement Schedules.  All schedules for which provision is made in the applicable accounting regulations of the Securities and Exchange Commission are not required under the related instructions, are not applicable,

* Management contract or the information is included in the Consolidated Financial Statements, and therefore have been omitted.

 3.Exhibits.  The following exhibits, are filed as part of, or incorporated by reference into, this report
2.1Share Exchange Agreement, dated February 29, 2016, by and among Spiral Energy Tech, Inc., Exactus BioSolutions, Inc. and the stockholders of Exactus BioSolutions, Inc. signatories thereto (attached as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed March 4, 2016 and incorporated herein by reference)
3.1 Amended and Restated Articles of Incorporation (attached as Exhibit 3.2 to the Company’s Registration Statement on Form S-1 (Registration No. 333-183360), filed August 16, 2012 and incorporated herein by reference)
3.2 Certificate of Amendment to Amended and Restated Articles of Incorporation (attached as Exhibit 3.1 to Amendment No. 2 to the Registration Statement on Form S-1 (Registration No. 333-183360, filed December 19, 2013 and incorporated herein by reference)
3.3 Articles of Merger, dated March 10, 2016, between Exactus Acquisition Corp. and Spiral Energy Tech, Inc. (attached as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed March 28, 2016 and incorporated herein by reference)
3.4 Certificate of Designation for Series A Preferred Stock (attached as Exhibit 3.1 to the Company’s Amendment to the Current Report on Form 8-K/A filed February 17, 2016 and incorporated herein by reference)
3.5 Certificate of Designation for Series B-1 Preferred Stock (attached as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed March 4, 2016 and incorporated herein by reference)
3.6 Certificate of Designation for Series B-2 Preferred Stock (attached as Exhibit 3.2 to the Company’s Amendment to the Current Report on Form 8-K/A filed February 17, 2016 and incorporated herein by reference)
3.7
Amendment to Certificate of Designation After Issuance of Class or Series (attached as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed November 1, 2016 and incorporated herein by reference).
3.8 Certificate of Designation for Series C Preferred Stock (attached as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed July 7, 2016 and incorporated herein by reference)
3.8 Bylaws (attached as Exhibit 3.3 to the Company’s Registration Statement on Form S-1 (Registration No. 333-183360), filed August 16, 2012 and incorporated herein by reference)
4.1 Form of Leak Out Agreement by and between Spiral Energy Tech, Inc. and the holders signatory thereto (attached as Exhibit 4.1 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and incorporated herein by reference)
4.2 Stock and Warrant Subscription Agreement, between Exactus, Inc. and POC Capital, LLC (attached as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed July 7, 2016 and incorporated herein by reference)
4.3 Warrant to Purchase Common Stock of Exactus, Inc., dated June 30, 2016 (attached as Exhibit 10.3 to the Company’s Current Report on Form 8-K filed July 7, 2016 and incorporated herein by reference)
4.4
Form of Exchange Agreement for Series A Preferred Stock (attached as Exhibit 10.1 to the Company’s Amendment to the Current Report on Form 8-K/A filed February 17, 2016 and incorporated herein by reference)
4.5
Form of Subscription Agreement for Series B-2 Preferred Stock (attached as Exhibit 10.2 to the Company’s Amendment to the Current Report on Form 8-K/A filed February 17, 2016 and incorporated herein by reference)
4.6
Leak-Out Agreement dated October 13, 2016 between Exactus, Inc. and MagnaSci Fund LP (attached as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed November 1, 2016 and incorporated herein by reference).
10.1 Master Services Agreement, dated June 30, 2016, between Exactus, Inc. and Integrium, LLC (attached as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed July 7, 2016 and incorporated herein by reference)
10.2 Amended and Restated Collaboration and License Agreement dated August 18, 2016 between Digital Diagnostics Inc. and Exactus BioSolutions, Inc. (attached as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and incorporated herein by reference)**
10.3 Consulting Agreement, dated January 20, 2016, between Exactus BioSolutions, Inc. and KD Innovation Ltd. (attached as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and incorporated herein by reference) (+)
10.4 Employment Agreement, dated December 15, 2015, between Exactus BioSolutions, Inc. and Philip J. Young (attached as Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and incorporated herein by reference) (+)
10.5 Employment Agreement, dated December 15, 2015, between Exactus BioSolutions, Inc. and Timothy J. Ryan (attached as Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and incorporated herein by reference) (+)
10.6Employment Agreement, dated March 16, 2017, between Exactus, Inc. and Kelley Wendt (attached as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed March 22, 2017 and incorporated herein by reference). (+)
10.7
Employment Agreement, dated December 1, 2016, between Exactus, Inc. and James R. Erickson (attached as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed December 8, 2016 and incorporated herein by reference) (+)
21.1Subsidiary List (attached as Exhibit 21.1 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and incorporated herein by reference)
31.1Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)
31.2Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)
32.1Certification of Chief Executive Officer pursuant to Rule 18 U.S.C Section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley act of 2002 (filed herewith)
32.2Certification of Chief Financial Officer pursuant to Rule 18 U.S.C Section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley act of 2002 (filed herewith)
101
Interactive Data Files
+ Indicates management compensatory plan contract or arrangement.

**Certain portions Exhibits and/or Schedules have been omitted. The Company hereby agrees to furnish to the Securities and Exchange Commission upon request any omitted information.

*** This exhibit is being furnished rather than filed and shall not be deemed incorporated by reference into any filing, in accordance with Item 601 of Regulation S-K.

+Portions of this exhibit have been omitted pursuant to a confidential treatment request granted on September 23, 2016, pursuant to Rule 24b-2as permitted by the rules of the Securities Exchange ActSEC. The information excluded is both (i) not material and (ii) the type that the Company customarily and actually treats as private or confidential. The Company undertakes to submit a marked copy of 1934. Omitted informationthis exhibit for review by the SEC Staff, to the extent it has not been filed separately withpreviously provided, and provide supplemental materials to the SecuritiesSEC Staff promptly upon request.

Copies of this Report (including the financial statements) and Exchange Commission.any of the exhibits referred to above will be furnished at no cost to our shareholders who make a written request to Panacea Life Sciences Holdings, Inc., at the address on the cover page of this Report, Attention: Corporate Secretary.

Item 16. Form 10-K Summary

Not applicable.

26

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Panacea Life Sciences Holdings, Inc.
EXACTUS, INC.
Date: March 30, 2023By:/s/ Leslie Buttorff
Date: March 31, 2017By:/s/ Philip J. YoungLeslie Buttorff
Philip J. Young
President,

Chief Executive Officer and Chairman of the Board

Chief Financial Officer

(Principal Executive Officer)

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated on March 31, 2017.
Date: March 31, 2017By:/s/ Philip J. Young
Philip J. Young
President, Chief Executive Officer and Chairman of the Board
(Principal Executive Officer)
Date: March 31, 2017By:/s/ Kelley A. Wendt
Kelley A. Wendt
Chief Financial Officer
(Principal Financial and Principal Accounting Officer)

Date: March 31, 2017By:/s/ Timothy Ryan
Timothy Ryan
Executive Vice President and Director
Date: March 31, 2017By:/s/ Krassen Dimitrov
Krassen Dimitrov
Director
27
EXHIBIT INDEX
Exhibit No.Description
2.1Share Exchange Agreement, dated February 29, 2016, by and among Spiral Energy Tech, Inc., Exactus BioSolutions, Inc. and the stockholders of Exactus BioSolutions, Inc. signatories thereto (attached as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed March 4, 2016 and incorporated herein by reference)
3.1 Amended and Restated Articles of Incorporation (attached as Exhibit 3.2 to the Company’s Registration Statement on Form S-1 (Registration No. 333-183360), filed August 16, 2012 and incorporated herein by reference)
3.2 Certificate of Amendment to Amended and Restated Articles of Incorporation (attached as Exhibit 3.1 to Amendment No. 2 to the Registration Statement on Form S-1 (Registration No. 333-183360, filed December 19, 2013 and incorporated herein by reference)
3.3 Articles of Merger, dated March 10, 2016, between Exactus Acquisition Corp. and Spiral Energy Tech, Inc. (attached as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed March 28, 2016 and incorporated herein by reference)
3.4 Certificate of Designation for Series A Preferred Stock (attached as Exhibit 3.1 to the Company’s Amendment to the Current Report on Form 8-K/A filed February 17, 2016 and incorporated herein by reference)
3.5 Certificate of Designation for Series B-1 Preferred Stock (attached as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed March 4, 2016 and incorporated herein by reference)
3.6 Certificate of Designation for Series B-2 Preferred Stock (attached as Exhibit 3.2 to the Company’s Amendment to the Current Report on Form 8-K/A filed February 17, 2016 and incorporated herein by reference)
3.7Amendment to Certificate of Designation After Issuance of Class or Series (attached as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed November 1, 2016 and incorporated herein by reference).
3.8 Certificate of Designation for Series C Preferred Stock (attached as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed July 7, 2016 and incorporated herein by reference)
3.8 Bylaws (attached as Exhibit 3.3 to the Company’s Registration Statement on Form S-1 (Registration No. 333-183360), filed August 16, 2012 and incorporated herein by reference)
4.1 Form of Leak Out Agreement by and between Spiral Energy Tech, Inc. and the holders signatory thereto (attached as Exhibit 4.1 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and incorporated herein by reference)
4.2 Stock and Warrant Subscription Agreement, between Exactus, Inc. and POC Capital, LLC (attached as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed July 7, 2016 and incorporated herein by reference)
4.3 Warrant to Purchase Common Stock of Exactus, Inc., dated June 30, 2016 (attached as Exhibit 10.3 to the Company’s Current Report on Form 8-K filed July 7, 2016 and incorporated herein by reference)
4.4Form of Exchange Agreement for Series A Preferred Stock (attached as Exhibit 10.1 to the Company’s Amendment to the Current Report on Form 8-K/A filed February 17, 2016 and incorporated herein by reference)
4.5Form of Subscription Agreement for Series B-2 Preferred Stock (attached as Exhibit 10.2 to the Company’s Amendment to the Current Report on Form 8-K/A filed February 17, 2016 and incorporated herein by reference)
4.6Leak-Out Agreement dated October 13, 2016 between Exactus, Inc. and MagnaSci Fund LP (attached as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed November 1, 2016 and incorporated herein by reference).
10.1 Master Services Agreement, dated June 30, 2016, between Exactus, Inc. and Integrium, LLC (attached as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed July 7, 2016 and incorporated herein by reference)
10.2 Amended and Restated Collaboration and License Agreement dated August 18, 2016 between Digital Diagnostics Inc. and Exactus BioSolutions, Inc. (attached as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and incorporated herein by reference)**
10.3Consulting Agreement, dated January 20, 2016, between Exactus BioSolutions, Inc. and KD Innovation Ltd. (attached as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and incorporated herein by reference) (+)
10.4Employment Agreement, dated December 15, 2015, between Exactus BioSolutions, Inc. and Philip J. Young (attached as Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and incorporated herein by reference) (+)
10.5Employment Agreement, dated December 15, 2015, between Exactus BioSolutions, Inc. and Timothy J. Ryan (attached as Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and incorporated herein by reference) (+)
10.6Employment Agreement, dated March 16, 2017, between Exactus, Inc. and Kelley Wendt (attached as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed March 22, 2017 and incorporated herein by reference). (+)
10.7Employment Agreement, dated December 1, 2016, between Exactus, Inc. and James R. Erickson (attached as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed December 8, 2016 and incorporated herein by reference) (+)
21.1Subsidiary List (attached as Exhibit 21.1 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and incorporated herein by reference)
31.1Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)
31.2Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)
32.1Certification of Chief Executive Officer pursuant to Rule 18 U.S.C Section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley act of 2002 (filed herewith)
32.2Certification of Chief Financial Officer pursuant to Rule 18 U.S.C Section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley act of 2002 (filed herewith)
101 INSXBRL Instance Document
101 SCHXBRL Taxonomy Extension Schema Document
101 CALXBRL Taxonomy Calculation Linkbase Document
101 LABXBRL Taxonomy Labels Linkbase Document
101 PREXBRL Taxonomy Presentation Linkbase Document
101 DEFXBRL Taxonomy Extension Definition Linkbase Document
+ Indicates management compensatory plan, contract or arrangement.
**Certain portions of this exhibit have been omitted pursuant to a confidential treatment request granted on September 23, 2016, pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. Omitted information has been filed separately with the Securities and Exchange Commission.
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