UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON,Washington, D.C. 20549

FORM 10-K

[X](Mark One)

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

For the Fiscal Year Ended fiscal year ended: December 31, 2015

2021

 [  ]

OR

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

FOR THE TRANSITION PERIOD FROM

Commission File Number:No. 000-27237

000-27237

(720) 587-5100

(Exact name of registrant as Specified in its Charter)

              Nevada

65-0622463

(State or Other Jurisdiction of

(Internal Revenue Service

Incorporation or Organization)

Employer Identification Number)

9101 Harlan Street Suite 130 Westminster, CO

80031

(Address of Principal Executive Offices)

(Zip Code)

Registrant’sRegistrant’s telephone number, including area code:  code)

(303) 439-2085

Securities registered pursuant to Section 12(b) of the Exchange Act:None.

None

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

Common Stock, par value $0.001 per share

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

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

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 preceding 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 x☒ No ¨         ☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive 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 x☒ 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’sregistrant’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.  Yes x No ¨

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

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

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

The issuer's revenues for the most recent fiscal year ended December 31, 2015 were $0.

The aggregate market valueAs of 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 as ofJune 30, 2021, the last business day of the registrant’sRegistrant’s most recently completed second fiscal quarter, the market value of our common stock held by non-affiliates was approximately $23,711.$620,312 based on the closing price of $0.03 on the same day.

State theThe number of shares of the issuer’sRegistrant’s common stock, $0.001 par value per share, outstanding as of the latest practicable date: 38,183,086 shares of common stock issued and outstanding as of May 11, 2016.  

FORM 10-KApril 13, 2022, was 34,083,319.

FOR THE FISCAL YEAR ENDED DECEMBER 31, 2015Documents incorporated by reference: NONE

FORM 10-K

TABLE OF CONTENTS

Part I

Part II

Part III

Forward-Looking Statements

CERTAIN STATEMENTS IN THIS ANNUAL REPORT MAY CONSTITUTE “FORWARD LOOKING STATEMENTS”. WHEN THE WORDS “BELIEVES,” “EXPECTS,” “PLANS,” “PROJECTS,” “ESTIMATES” AND SIMILAR EXPRESSIONS ARE USED, THEY IDENTIFY FORWARD-LOOKING STATEMENTS. THESE FORWARD-LOOKING STATEMENTS ARE BASED ON MANAGEMENT’S CURRENT BELIEFS AND ASSUMPTIONS AND INFORMATION CURRENTLY AVAILABLE TO MANAGEMENT AND INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND OTHER FACTORS WHICH MAY CAUSE THE ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS OF THE COMPANY TO BE MATERIALLY DIFFERENT FROM ANY FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS EXPRESSED OR IMPLIED BY THESE FORWARD-LOOKING STATEMENTS. INFORMATION CONCERNING FACTORS THAT COULD CAUSE OUR ACTUAL RESULTS TO DIFFER MATERIALLY FROM THESE FORWARD-LOOKING STATEMENTS CAN BE FOUND IN OUR PERIODIC REPORTS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. WE UNDERTAKE NO OBLIGATION TO PUBLICLY RELEASE REVISIONS TO THESE FORWARD-LOOKING STATEMENTS TO REFLECT FUTURE EVENTS OR CIRCUMSTANCES OR REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS.

Unless otherwise indicated, references in this report to “we,” “us, “our”, “GeneThera”, and the “Company” refer to, collectively, GeneThera, Inc., a Nevada corporation, and its consolidated subsidiary, GeneThera, Inc., a Colorado corporation.

Special Note Regarding Forward Looking Statements

This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, which are subject to the “safe harbor” created by those sections / acts. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. All statements other than statements of historical facts are “forward-looking statements” for purposes of these provisions. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions intended to identify forward-looking statements.

PART I.

FORWARD-LOOKING AND CAUTIONARY STATEMENTS

Sections of this Form 10-K, including BusinessThese statements involve known and Management's Discussion and Analysis or Plan of Operation, contain "forward-looking statements". These forward-looking statements are subject tounknown risks, and uncertainties and other factors, thatwhich may cause our actual results, performance, time frames or achievements to be materially different from theany future results, performance, time frames or achievements expressed or implied by the forward-looking statements. We discuss many of these risks, uncertainties and other factors in this Annual Report on Form 10-K in greater detail under the heading “Risk Factors.” Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this filing. You should not unduly relyread this Annual Report on these statements. Forward-looking statements involve assumptionsForm 10-K completely and describewith the understanding that our plans, strategies, and expectations. You can generally identify a forward-looking statement by words such asactual future results may will, should, would, could, plan, goal, potential, expect, anticipate, estimate, believe, intend, project, and similar words and variations thereof. This report containsbe materially different from what we expect. We hereby qualify our forward-looking statements that address, among other things,

* Our financing plans,

* Regulatory environments in whichby these cautionary statements. Except as required by law, we operateassume no obligation to update these forward-looking statements publicly, or plan to operate, and

*Trends affecting our financial condition or results of operations,update the impact of competition, the start-up of certain operations and acquisition opportunities.

Factors, risks, and uncertainties that could causereasons actual results tocould differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

Potential investors should not place undue reliance on any forward-looking statements ("Cautionary Statements") include, among others,

* Our ability to raise capital,

* Our ability to execute our business strategy in a very competitive environment,

* Our degree of financial leverage, risks associated with our acquiring and integrating companies into our own,

* Risks relating to rapidly developing technology, and regulatory considerations;

* Risks related to international economies,

* Risks related to market acceptance and demand for our products and services,

* The impact of competitive services and pricing, and

* Other risks referenced from time to time in our SEC filings.

All subsequent written and oral forward-looking statements attributable to us, or anyone acting on our behalf, arestatements. Except as expressly qualified in their entiretyrequired by the cautionary statements. We do not undertake any obligationsfederal securities laws, there is no undertaking to publicly release any revisions toupdate or revise any forward-looking statements, to reflectwhether as a result of new information, future events, changed circumstances or circumstances afterany other reason.

The specific discussions herein about the date ofCompany include financial projections and future estimates and expectations about our business. The projections, estimates and expectations are presented in this report only as a guide about future possibilities and do not represent actual amounts or to reflect unanticipated events that may occur.

ITEM 1. BUSINESS

In November 2007, GeneThera, Inc. (“we”, “us”,assured events. All the “Company” or “GeneThera”) reincorporatedprojections and estimates are based exclusively on our management’s own assessment of our business, the industry in the State of Nevada due to the fact that a third party had acquired the Company’s prior Florida Corporate Charterwhich we work and the fact thateconomy at large and other operational factors, including capital resources and liquidity, financial condition, fulfillment of contracts and opportunities. The actual results may differ significantly from the Company was unable to regain the control of such Corporate Charter. We had a special meeting of shareholders where it was unanimously resolved for GeneThera to transfer its Charter to the State of Nevada as soon as possible in order to recognize our new incorporationprojections. Potential investors should not make an investment decision based solely on our next SEC filing. The reinstatement was completed by January 2008.projections, estimates or expectations.

Our common stock currently trades on the OTC “Over-The-Counter” pink market under the symbol GTHR.  Our temporary office is located at 9101 Harlan Street Suite 130 in Westminster, CO 80031 and our telephone number is 303-439-2085. This office only answers the phone calls until our new laboratory space’s new lease agreement and renovationsPART I

ITEM 1.BUSINESS

Company Overview

We are completed.

For the fiscal year 2015, and as of now, the Company had one subsidiary, GeneThera, Inc., a Colorado corporation. GeneThera no longer has holds a commercial diagnostics laboratory in Mexico.

COMPANY PROFILE

GeneThera is a biotechnology company dedicated to improving food safety byapplying the latest molecular technologies to eradicate "cross-over"(zoonotic)eradicating zoonotic diseases such as Johne's Disease,COVID-19 (Novel Coronavirus), Paratuberculosis (Johne’s disease), Mad Cow Disease, Chronic Wasting Disease, and E.coli.E.coli and Salmonella infections, by applying our advanced proprietary molecular sciences and technologies. Diseases of terrestrial, avian and aquatic life animals influence a number of economic and global security issues;issues, including food for an increasing world population, access to international trade, species conservation and protection of those endangered, and economic growth in developing and re-organizing nations. Because manymore than 80% of animal disease agentsbacteria and viruses are zoonotic (transmissible(i.e. transmissible between humans and animals, causing infection in both species), their management and prevention are crucial to improving public health on a global scale. The Company focusesZoonotic diseases are the major cause of global pandemics throughout human history. These diseases are capable of altering human history by causing significant loss of life, and major economic and social upheaval. We focus on developing novel molecular diagnostic tests, therapeutics, and vaccines inthrough our proprietary robotic technologies with the belief that betterimproved technologies and methodology needmethodologies must be developed and implemented in order to be implemented to helpaid mankind’s control of emerging diseases in animals and in humans, and believeshumans. We believe that, if not theseproperly addressed, diseases in animals will likely continue to cause serious and growing global problems in terms ofwith respect to economics, human health and biodiversity.

GeneThera has

We previously developed proprietary diagnostic assays for use in the agricultural and veterinary markets. Specificmarkets, and we intent to develop proprietary, genetics-based diagnostic assays for Chronic Wasting Disease (among elk and deer) and Mad Cow Disease (among cattle) have been developed and are available currently on a limited basis.  E. coli (predominantly cattle) and Johne's disease (predominantly dairy cattle and bison) diagnostics are in development. GeneThera is making a pivotal shift from a Research and Development organization into a product marketing and revenue generating entity.  The Company’s previous strategy that we had maintained from inception to July 2008 had been onevaccine solutions through our robotic technologies with the goal of research only. We focused all our energies, talent, and resources tocontrolling the incubation and growthspread of new ideaszoonotic infection in the realm of genetically engineered disease detection and vaccination. We feel that with recent announcements

the Companyhuman population. Our mission is positioned to move from a developmental stage to a product oriented stage company, depending on reliable funding.

GeneThera provides genetics-based diagnostic and is currently working on vaccine solutions to meet the growing demands of today's veterinary industry and tomorrow's agriculture and healthcare industries. The Company is organized and operated both to continually apply itsour scientific research to the more effective management of zoonotic diseases and, in so doing, realize the commercial potential of our molecular biotechnology.biotechnologies.

The Company believes itWe will require significant additional funding in order to achieve itsimplement our business plan. Over the next 12 months, in order to have the capability of achieving its business plan, the Company will require at least $10,000,000 in additional funding.  There areis no guaranteesguarantee that the Companywe will be able to secure suchsuccessful in securing the required financing, and if thesuch financing is secured, there areis no guarantees whether the Company canguarantee that we will fully achieve our business goals.

Target Zoonotic Diseases

COVID-19

COVID-19 is an infectious disease caused by SARS- CoV-2. Common symptoms include fever, cough and shortness of breath. Other symptoms may include muscle pain, diarrhea, sore throat, and loss of smell. The majority of cases result in mild symptoms. However, some cases progress to viral pneumonia and multi-organ failure. SARS-Cov-2 coronavirus is the goals laid outlatest example of a long list of viruses and bacteria that can cause widespread global infection in humans. As of early June 2020, the number of infectious cases worldwide were close to seven and a half million with more than 415,000 deaths. In December 2019, SARS- Cov-2 was first discovered in the city of Wuhan, China. In February 2020, the World Health Organization (WHO) declared COVID-19 a global pandemic. The SARS-Cov-2 is a genetically mutated strain of the SARS-Cov-1 virus that caused SARS in 2003-2004 epidemic. Coronaviruses are opportunistic viruses that are harbor in the Asian bat population. Pangolins, nocturnal mammals, native to Asia and Africa especially tropical forests, are the most likely intermediate carriers of the SARS-Cov-2 between bats and humans. In 2002–03, Civet cats, nocturnal mammals found in Asia and Africa sold for meat in local markets of China’s Yunnan province carried the SARS virus from bats to humans.

SARS-CoV-1 and 2’s abilities to genetically mutate through passages into humans is one of the reasons of their enhanced virulence. Coronaviruses are easily transmitted by human-to-human close contact primarily through saliva droplets. Coronaviruses are “positive single stranded (ss) RNA virus. These types of viruses can replicate into human cells without using the host DNA as a template. Positive single stranded RNA viruses have genetic material that can function both as genome and messenger RNA. This feature allows the Coronaviruses to work more efficiently once it infects its business plan.target. SARS-Cov-2 is the etiological cause of COVID-19, a highly infectious respiratory disease causing an atypical pneumonia.

Johne’s DiseaseThe mechanism of infections to humans is through saliva droplets caused by persistent cough and sneezing. Indirect contact with contaminated surfaces is another way of infection although it is not a very efficient way of transmission. Viral RNA is also being found in the stools of infected patients. SARS-Cov-2 is able to enter human cells by binding to the ACE2 cell receptor. Once inside the cells, the virus starts the process of replication by using its own RNA polymerase enzyme. The incubation time COVID-19 varies between 2-14 days. It is not clear if during the incubation period, the virus is able to infect humans.

GeneThera’s focus includesMajor clinical symptoms and epidemiological risk factors related to COVID-19:

Epidemiological evidences support the diagnosishypothesis that SARS-CoV-2 neuronal cells in the medulla oblongata region of the brain could become infected with the virus. Anosmia (loss of smell) and ageusia (loss of taste) are reported to be early signs of COVID-19. In some cases the neuronal infection of the medulla oblongata can contribute to a patient’s breathing problems and respiratory failure within five days from the infection. SARS-CoV-2 enters human cell by binding the ACE2 receptor. The ACE2 protein regulates cardiovascular function and is express in many human cells including lung, heart, kidney, intestine, and brain tissue. There are multiple ways the virus could invade the central nervous system. A possible mechanism of action is that the SARS-CoV-2 is in the blood of infected patients and through this infectious route binds to ACE2 receptors in the endothelial cells of the blood capillaries in the brain, breaching the blood-brain barrier and invading neurons through that route. A breached blood-brain barrier could also cause brain swelling, compressing the brain stem and affecting respiration. The cells innervating the lungs could also become infected, making involuntary respiration more difficult.

Evidence from experiments in mice also suggest that the virus might target the nervous system through the olfactory bulb. A study published in 2008 (Netland et al. J Virology 2008 Aug (15): 7264-7275) showed that SARS-CoV-1 — the virus that caused the SARS outbreak in 2003 — entered the brains of transgenic mice expressing human ACE2 through neurons in the nose. The virus then rapidly spread to connecting nerve cells. The extensive nerve damage was the major cause of death, even though, low levels of the virus were detected in the animals’ lungs. It is therefore possible that the respiratory failure in patients with COVID-19 could be caused from the extensive neuronal damages in the cardiorespiratory area of the medulla oblongata.

Diagnostics assays and Treatment of COVID -19

Nasopharyngeal, oropharyngeal swabs and saliva specimen are collected from patients to detect the SARS-Cov-2 viral infection. Viral RNA is extracted from the swab and amplified using the Real Time Polymerase Chain reaction (RT-PCR) technology. The COVID-19 detection molecular assay is a multi-step procedure that requires up to 72 hours to obtain a result. Because of the complexity of the assay, a limited number of samples can be manually processed daily. Limitations in the number of samples to be process is the main reason of the spreading of the COVID-19. Automated systems such as the Roche COBA 8800 are capable of processing up to 4,000 samples/daily. However, due to the sheer number of potentially infected people globally, this system could not fully meet assay demand.

Currently, no treatment is available to treat COVID-19. Influenza vaccines are not effective to stop the spread of Johne’s disease.COVID-19 infection. Several COVID-19 vaccines are currently in Phase I clinical trials. Estimated development time is between 15-18 months. Alternatively, “off label” drug combination protocols have been used, with various degree of success, to treat COVID-19 patients.

Johne’s

Paratuberculosis

Paratuberculosis, also known as Johne’s disease in Stage III clinical phase, is a worldwide problem ofin domestic livestock animals primarily including dairy cattle, sheep and goats. A significant public health concern is associated with Johne's disease (JD),Paratuberculosis, which results from an infection with bacteria calledthe Mycobacterium paratuberculosis.Avium Sub Paratuberculosis (MAP) bacteria. This bacterial organism grows very slowly, causes a gradually worsening disease condition, and is highly resistant to the infected animal'sanimal’s immune defenses. Therefore, infected animals harbor the organism for years before they test positive or develop disease signs.

Major Factorsfactors related to Johne's disease:a MAP infection include:

·

Worldwide Infection.

·

Reduction in milk productionSeventy to 25%+.

·

High culling rate which increases costs.

·

JD affects trade and hinders exports.

·

Link between JD and Crohn’sninety percent of the herds worldwide are infected with MAP. Most of the infected animals do not show any clinical signs of the disease.

·

Reduction in quality wool production in sheep.

·

Highest at risk The majority of infected animals are young calves or pre-born.capable of shedding billions of bacteria mostly in the soil and milk without ever developing clinical signs of paratuberculosis and are responsible for the spreading of the disease to other animals and for the transmission of MAP to humans, mostly through milk. Lack of routine testing has resulted in the inability of managing MAP infection worldwide. MAP is resistant to conventional pasteurization protocols. Therefore, many of the dairy products, infant formula, and milk sold in stores are contaminated with the bacterium.

·

Bacterium can survive in contaminated soil for over 1 year.

·

Spread in herds can occur by fecal contamination, colostrum, milk, and transplacental.

·

Calves can become infected by suckling on “dirty” teats.

·

For every one “clinical stage” in a herd there are 15-20 silently infected plus additional 6-8 carriers.

Stage I: Silent, subclinical, non-detectable infection. Typically, this stage occurs in all calves, heifers, and young stock less than two years of age and many adult animals exposed to small doses of disease-causing organisms. Infected animals at this early stage

are rarely detected with currently available diagnostic tests, including fecal culture or serologic tests (ELISA). This stage progresses slowly over many months or years to stage II.

Stage II: Subclinical infection. Typically, this stage occurs in older heifers or adults. Animals at this stage appear healthy but are shedding adequate numbers of MAPMycobacterium Avian Para tuberculosis organisms in their manure to be detected on fecal culture. Blood tests will detect some, but not all animals at this stage. Blood test (ELISA) positive animals should be confirmed positive by fecal culture.

Stage III: Clinical JD.Johne’s disease. It is categorized as any animal with advanced infection, the onset of which is often associated with a period of stress such as recent calving. Cattle at this stage have intermittent, watery pea-soup manure. Animals lose weight and gradually drop in milk production but continue to havemaintain a goodhealthy appetite. Some animals appear to recover but often relapse in the next stress period. Most of these animals are shedding billions of organisms and are positive on culture. Most are positive on serologic tests (ELISA & AGID)(ELISA). Clinical signs often last several weeks to months before the animals are sent to slaughter in a thin, emaciated condition. In the final and terminal aspects of stage III of the fatal disease, animals become emaciated with fluid diarrhea and develop “bottle“bottle jaw.” The carcass may not pass meat inspection for human consumption in the later phases of stage III.

Crohn’sMAP and Immunodeficiency Diseases

A large number of studies show that several immunodeficiency diseases including, Crohn’s Disease (CD) a chronic inflammatory disease of the intestine and colon, Type 1 Diabetes and Multiple Sclerosis can be triggered by MAP. The bacterium is therefore a zoonotic infectious organism which can be transmitted through contaminate milk, infant formula and water.

Crohn'sMAP Related Immunodeficiency Diseases

Crohn’s Disease

Crohn’s disease (also known as Crohn-Leśniowski Disease, or "Charlotte Forditis" morbus Leśniowski-Crohn, granulomatous and regional enteritis) is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. It primarily causes abdominal pain, diarrhea (which may be bloody), vomiting, or weight loss, but may also cause complications outside of the gastrointestinal tract such as skin rashes, arthritis, and inflammation of the eye.

Crohn's

Crohn’s disease is an autoimmuneimmunodeficiency disease, in which the body'sbody’s immune system attacks the gastrointestinal tract, causing inflammation; itinflammation. It is classified as a type of inflammatory bowel disease. There has been evidence of a genetic link to Crohn'sCrohn’s disease, putting individuals with siblings afflicted with the disease at higher risk. It is understood to have a large environmental component as evidenced by the higher number of cases in western industrialized nations. Males and females are equally affected. Smokers are three times more likely to develop Crohn'sCrohn’s disease than non-smokers. Crohn'sCrohn’s disease affects between 400,000 and 600,000 people in North America. Prevalence estimates for Northern Europe have ranged from 27–27–48 per 100,000. Crohn'sCrohn’s disease tends to present initially in the teens and twenties, with another peak incidence in the fifties to seventies; although, the disease can occur at any age.

Histological alterations found in Crohn’s patients’ intestinal tract, closely resembles similar tissue changes observed in the intestine of Johne’s disease cattle.

Similar to Johne’s diseaseParatuberculosis in cattle, no known pharmaceutical or surgical cure for Crohn'sCrohn’s disease currently exists for humans. Furthermore, new discoveries of MAPMycobacterium Avian Paratuberculosis have been

found in human patients and we believe that individuals that are genetically predisposed could possibly be contracting the disease through digestion of Johne’s diseaseMAP - infected milk.dairy products.

BUSINESS MODEL

GeneTheraBusiness Model

Molecular Robotic Artificial Intelligence (AI) Integrated Platform (MORAP)

It has become evident from the COVID-19 global pandemic that current systems and related technologies are not capable of preventing or successfully controlling the spreads of zoonotic infectious agents. One of the features of these infectious organisms is their ability to infect both people and animals while some carriers remain asymptomatic for a period of time or for the entire duration of the infection. We believe it is imperative that during pandemic outbreaks the entire population must be tested for the presence of infection agents. In addition, we believe that AI models should be developed proprietary diagnostic assays for useto analyze data and forecast zoonotic diseases outbreak and ultimately prevent epidemics and pandemics from occurring in the agriculturalfuture. GeneThera’s goal is to develop the infrastructure of a nationwide zoonotic infectious agents “alert shield” which would operate to predict, detect and veterinary markets. Specific assays for Chronic Wasting Disease (among elkmanage the spread of pandemics and deer) and Mad Cow Disease (among cattle) have been developed and are available currently on a limited basis.  E. coli (predominantly cattle) and Johne's disease (predominantly dairy cattle and bison) diagnostics are in development. GeneThera is making a pivotal shiftultimately prevent pandemics from a Research and Development organization into a product marketing and revenue generating entity, depending on reliable source of funding.  The Company’s previous strategy that we had maintained from inception to July, 2008 had been one of research only. We focused all our energies, talent, and resources to the incubation and growth of new ideas in the realm of genetically engineered disease detection and vaccination. We feel that with recent announcements the Company is positioned to move from a developmental stagedeveloping, similar to a product oriented stage company once funding“nuclear shield,” which is secured.designed to detect incoming nuclear warheads and destroy them before they can be deployed. We believe that a nationwide network of AI controlled laboratory robotic systems may be able to perform such a task.

GeneThera provides genetics-based diagnostic and is currently working on vaccine solutions to meet the growing demands of today's veterinary industry and tomorrow's agriculture and healthcare industries. The Company is organized and operated both to continually apply its scientific research to more effective management of diseases and, in so doing, realize the commercial potential of molecular biotechnology.

GeneThera animal disease assay developmentOur business model is based on its Integrated Technologyan Ultra High Throughput Molecular Robotic/AI Platform (ITP)(MORAP) which combines the use of advance robotic integrated systems with AI and Machine Learning (ML) software systems. Upon development, MORAP would encompass a nationwide network of interactive molecular laboratories operated using advanced integrated robotic and machine learning cloud-based software systems, which would be able to share data and interact with each other. We believe the MORAP would be capable of processing millions of samples and collecting, storing and analyzing data. We believe that combinesthe MORAP nationwide communications network could be accomplished through advanced cloud-based software systems, machine learning and Internet-of-Things (IoT) networks. MORAP could be readily replicated and scaled utilizing identical instrumentation and software.

We have designed the MORAP’s second generation molecular robotic/AI laboratory system prototype. Upon development subject to securing the requisite funding, each individual MORAP system would be capable, in a proprietary diagnostic solution called Gene Expression System (GES)full-scale commercial platform, to perform over 100,000 samples/daily with PURIVAX, itsminimal human intervention.

We envision the MORAP’s cloud-based AI-integrated software system for analyzing large-scale DNA sequencing.  The first part of this platform iswith a dual purpose: 1) data obtained from each individual robotic laboratory system would be sent to the ongoing development of molecular diagnostic assays solutions using real time Fluorogenic Polymerase Chain Reaction (F-PCR) technologycloud to detect the presence of infectious disease from the blood of live animals.  The secondbe stored where data could be analyzed and risk factors could be evaluated; and 2) each individual robotic laboratory system as part of the ITPMORAP network could be configured in the cloud. The individual robotic laboratory systems, identical in each location, would be controlled and operated through MORAP’s cloud-based software.

The MORAP’s cloud software architecture would:

Each individual robotic unit is composed of different equipment controlled by the developmentintegrated software. The MORAP cloud-base system would be function as the ‘brain’ of the entire network.

Our MORAP system is designed to targeted zoonotic diseases in general; however, we intend to focus our robotic/AI and therapeutic vaccines using RNA interferencevaccine technologies on SARS-Cov-2 and MAP related diseases.

Zoonotic Diseases Vaccine Development

Our therapeutic vaccine technology is based on the use of CRISPR gene editing technology. Interference RNACRISPR technology is a new technique that is based on the use of short RNA sequences complementary to a specific target gene. Once the RNA sequence binds to the gene, the gene is deactivated or “silenced”“silenced” and no longer able to produce the specific protein. It also allows for the efficient, effective, and continuous testing, management and treatment of animal populations. These facts distinguishWe plan to deliver CRISPR modified RNA sequences motif using our proprietary PURIVAX technology. Our focus will be to develop CRISPR based vaccines for SARS-COV-2 and MAP. Our strategy is to silence the technology from any alternative testing and management methodology available to agriculture today -- allexpression of gene pathways, which requireare activated by the destruction of individual animals and even entire herds.  Our testing and data analysis processes also allow us not only to separate infected from clean animals, but alsoinfectious agents to gain knowledge vital to development of preventative vaccines.

Each individual assay utilizes the proprietary Field Collection System (FCS) for the collection and transportation of blood samples to GeneThera laboratory.  This system consists of two (2) tubes. A 5 milliliter (ml) red cap tube containing 1ml anticoagulant

solution and a 10 ml white cap tube. One (1) ml of blood is collected from the animal and added to the red cap tube.  Ten (10ml) of milk is collectedentry into the white cap tube. The FCS allows GeneThera to maintain the integrity of each sample by the addition of specific reagents to test tubes contained in the system.  GeneThera FCS is designed to be an easy-to-use method of gathering blood samples from harvested or domesticated animals.  It ensures consistency of samples as well as increased assurance of each sample's integrity.host cells.

To date, GeneThera has successfully developed the ability to detect Chronic Wasting Disease, a disease affecting elk and deer in North America.  The release of commercialized Field Collection Systems and laboratory diagnostic testing occurred in October of 2003 as a marketing trial.  GeneThera has also successfully developed an assay for the detection of Mad Cow Disease, a disease recently found in the United States, but which has been in Europe for many years.  The Field Collection Systems are available for purchase from the Company.  Chronic Wasting Disease and Mad Cow Disease are both in the family of diseases called Transmissible Spongiform Encephalopathy (TSE).  Diagnostic assays for E. coli O157:H7 and Johne's disease are in the final stages of development.PURIVAX Technology

The Company, through GeneThera, is also developing vaccines for Chronic Wasting Disease and E. coli O157:H7.  The Company will need the approval of the USDA before the vaccines can be manufactured or sold.  The approval process for animal vaccines is time-consuming and expensive.  We anticipate that such approval, if it is obtained, may require more than $5 million and may require more than two years for each vaccine for which approval is sought.  Currently, we do not have the capital necessary to seek approval of any of our candidate vaccines, and we cannot provide any assurance that we will be able to raise the capital necessary for such approval on terms that are acceptable to us, if at all.  In addition, even if we are successful in raising the capital necessary to seek approval of any vaccine, there are no assurances that such an approval will be granted, or if granted, whether we will be able to produce and sell such vaccines following such an approval in commercial quantities or to make a profit from such production and sales.

INTEGRATED TECHNOLOGY PLATFORM (ITP)

GeneThera’s Integrated Technology Platform (ITP) is the foundation for “fast-track” rDNA vaccine development.  We are currently working on the development of a recombinant DNA vaccine for Johne’s disease.  Johne’s disease is a chronic debilitating infectious disease of ruminants, characterized by weight loss and, particularly in cattle, by profuse diarrhea.  The causal agent is a bacterium, Mycobacterium avium subspecies paratuberculosis.  Infected animals may show no sign of the disease until years after the initial infection.  Johne’s is a slow, progressive disease with worldwide distribution.

The vaccine development is in the “in vitro” or pre-clinical stage.  We expect to initiate experimental animal studies for Johne’s disease in the next 36-48 months.  ITP combines the following technologies: 1) gene expression system technology or “GES”; 2) viral DNA purification technology or PURIVAX technology; 3) genetically engineered Adenovirus (rAD) and recombinant Adeno Associate Virus (rAAV) systems (vectors).

This integrated technology platform yields fast-track vaccine development.  Leveraging its ITP, GeneThera believes that it can develop a prototype vaccine within 18 months versus the current standard of 24 to 36.  We estimate that the cost to bring these vaccines to market is $5-7 million.  There is no assurance that we will be able to raise the capital necessary to bring a vaccine to market and if the capital is raised, that we will be able to comply with the government regulations involved in bringing such a product to market. The GES applied modular unit system utilizes robotics and is based on nucleic acid extraction in conjunction with F-PCR technology to develop gene expression assays. Using GES assays, vaccine efficacy can be measured quickly because it will be unnecessary to wait for the antibody response to measure how well the vaccine is working.  F-PCR will allow effective quantification of the precise number of viral or bacterial genetic particles before, during and after vaccine injection(s).  We anticipate that the more effective the vaccine is, the stronger the decrease of the infectious disease particles will be.

GES SYSTEM

GES is a proprietary assay development system.   To date, the system has been used to develop our TSE and Johne’s disease molecular assay. GES is a gene expression system to be used in our laboratory and will be marketed for commercial sale under the trade name HERDCHECK.  The core of GES is Fluorogenic Polymerase Chain Reaction technology (F-PCR).  GeneThera approaches the technical problems related to the use of conventional PCR in molecular diagnostics via our modular unit concept.  Specifically, the modular unit consists of an Automated Nucleic Acid Workstation (ANAW) and a Sequence Detection System (SDS) that are integrated, allowing an operator to perform the entire procedure of DNA extraction and F-PCR analysis within a closed computerized system.  This system results in minimal intervention and non-post-PCR manipulation. GES is a molecular genetic base system that utilizes Fluorogenic Polymerase Chain Reaction (F-PCR).  Fluorogenic PCR (F-PCR) is a technology based on sequence specific hybridization between a nucleic acid target and a fluorogenic probe, a short sequence of DNA chemically treated to generate light at a specific wavelength, complementary to the target sequence.  The probe consists of an oligonucleotide, a short synthetic DNA molecule, with two fluorescent molecules (a reporter and quencher dye) attached to both ends of the oligonucleotide.  Due to the unique design of the Fluorogenic probe, the activity of the Taq Polymerase enzyme allows direct detection of PCR products by the release of the fluorogenic reporter during PCR.  The reporter and the quencher dye are linked at the end of the probe. When the probe is intact, the proximity of the reporter dye to the quencher dye results in a suppression of the reporter fluorescence.  During PCR, if the target of interest is present, the probe specifically anneals between the forward and the reverse primer site.  The nuclease activity of the Taq DNA Polymerase cleaves the probe between the reporter and the quencher only if the region binds to the target.  If the probe is not bound then no cleavage occurs. After cleavage, the shortened probe dissociates from the target and the polymerization of the DNA strand continues.  This process occurs in every cycle and does not interfere with the exponential accumulation of the product.  The cleavage of the oligonucleotide between the reporter and the quencher dye results in an increase of fluorescence of the reporter

that is directly proportional to the amount of the product accumulated.  The specificity of this 5’ nuclease assay results from the requirement of sequence complementary between probe and template in order for cleavage to occur.  Thus, the fluorogenic signal is generated only if the target sequence of the probe is generated by PCR.  No signal is generated by non-specific amplification.

To perform GES, specific laboratory equipment is needed.  This involves some substantial initial costs to set up the laboratory operations.  We have performed this substantial set up and will be fully operational again to perform GES, once the laboratory renovations are completed.  We currently have an exclusive worldwide collaboration agreement with Hudson Robotics, Inc., which will provide the specific equipment necessary to further development.  However, the use of F-PCR represents a great advantage over other available systems because of its greater sensitivity, speed, and accuracy.

The Automated Nucleic Acid Workstation is a highly flexible robotic system that extracts and purifies acids from a variety of complex samples, preparing them for F-PCR analysis. Data management system software includes a database to manage all run phases and record sample processing.

The Sequence Detection System detects the fluorescent signal generated by the cleavage of the reporter dye during each PCR cycle.  This process confers specificity without the need of post-PCR hybridization.  Most importantly, the SDS offers the advantage of monitoring real-time increases in fluorescence during PCR processing.  Specifically, monitoring real-time progress of the PCR completely changes the approach to PCR-based quantitation of DNA and RNA, most particularly, in improving the precision in both detection and quantitation of DNA and RNA targets.

GeneThera currently faces limited competition in the use of F-PCR technology and the modular unit concept for commercial testing of either infectious disease in animals or food pathogen contamination.  Currently, most labs utilize conventional microbiology, immunological or conventional PCR methods for either veterinary diseases or food pathogen contamination detection.  Specific to microbiology and immunological techniques, the drawbacks of these approaches are:

1.

The antibodies-based culture media used to detect the presence of infectious

diseases has a low level of sensitivity; and

2. High background due to non-specific binding of antibodies and/or culture

contamination; sample preparation and storage creates artifacts; and long, cumbersome protocols necessary to perform these tests.

A major technical limitation of conventional PCR is the risk of contaminating a specimen with the products of previously amplified sequences.  Known as cross-contamination, this phenomenon represents a constant challenge to any lab using conventional PCR. Managing these challenges is cumbersome and difficult to streamline.  Fluorogenic PCR (F-PCR) attempts to overcome these drawbacks by making it possible for PCR to

efficiently test large numbers of samples even when major laboratory facilities are not readily available.  A novel methodology, F-PCR allows quantitative and qualitative detection of specific nucleic acid sequences in a sensitive, accurate, and rapid fashion.

PURIVAX TECHNOLOGY

GeneThera has developed a large-scale process for highly purified and high viral titer (viral concentration) Adenovirus and AAV genetically engineered viruses. This technology enables GeneTheraus to develop Adenovirus and AAV-based recombinant DNA vaccines for veterinary diseases and foodzoonotic pathogens. GeneThera’sOur PURIVAX is a purification system that dramatically improves biological purity and viral titer of recombinant Adenovirus and AAV vectors. PURIVAX is intended to completely eliminate toxic side effects associated with Adenoviruses and AAV vectors, thereby making it possible to develop highly immunogenic and safe recombinant DNA vaccines. Importantly, recombinant DNA (rDNA) vaccine technology represents a powerful tool for an innovative vaccine design process known as “genetic“genetic immunization.”

Recombinant Adenovirus (rAD)rAD and AAV (rAAV)rAAV vectors are the ideal candidates for a gene delivery system. These viruses can efficiently deliver genetic material to both dividing and non-dividing cells, thereby overcoming some of the obstacles encountered with first generation retroviral vectors.

Equally important, rAD and rAAV are engineered virus genomes that contain no viral gene. One of the key features for rAD and rAAV is their ability to infect a large variety of cells. However, two technical challenges had to be overcome to fully utilize rAD and rAAV in the development of rDNA vaccines:

1.

Lack of large scale purification system; and

2. Low viral titer.

Traditional technologies and first generationfirst-generation chromatography processes are limited both in terms of purity and yield. And, dueDue to the limitation of these purification technologies, adequate viral titers cannotmay not be achieved. We believe that the result is that there is currently no efficient system to deliver immunogenic genetic sequences into cells.

This is the significance of GeneThera’sour PURIVAX, rAD and rAAV system for rDNA vaccine development. Succinctly stated, it is designed to be able to achieve both high purity and high viral titer (up to 10e16 viral particles/eulate)eluate) based on its propriety multi-resin anion exchange chromatography system. GeneThera believesWe believe that biological contaminants such as endogenous retrovirus, bacterial, mycoplasma, non-specific nucleic acids, lipids, proteins, carbohydrates and endotoxins are eliminated during the purification process.

Product Development

PRODUCT DEVELOPMENT

GeneThera providesWe provide a comprehensive Johne’s solution that allows diagnosing, treating and managing herds at risk or already infected with Johne’s disease.

zoonotic diseases in animals and humans. Our proprietary Integrated Product DevelopmentMolecular Robotic/AI Platform (IPDP)and Therapeutic strategy (MORAPAT) is design to prevent the spread of Johne’s disease to healthyfrom animals and at the same time, allow to better control the disease in those herds where the disease is already present.

of zoonotic infectious agents. More importantly, we believe that the GeneTheraour platform cancould prevent the spread of the Mycobacteriumviruses and bacteria into the food chain.chain and subsequent infection of human population. An important part of this strategy is GeneThera’sour ability to detect the presence of a low number of infected particles in milkdifferent specimen tested for the presence of the Mycobacterium Paratuberculosis. Therefore,zoonotic virus and bacteria such as SARS- CoV-2 and MAP. Consequentially, our IPDPplatform is not only is able to detect Johne’s infected animals, but can also prevent potential human infections.

HERD GUARD

Herd Guard is our comprehensive Johne’s management solution that includes a diagnostic (HerdCheck), a therapeutic (HerdSafe), and a management system (HerdSoft) to eradicate or mitigate Johne’s disease.

HERDCHECK (Molecular Test)

HerdCheck is our diagnostic product. Samples are collected using a Field Collection System with includes specific collection tubes and ship to a GeneThera laboratory for processing.

The major features of the testing system are:

 High throughput system.

 Capable of more than 20,000 tests per month.

 Highly defined and structured testing system.

 Proprietary Real Time PCR technology.

HERDSAFE (Genetic Therapy)

HerdSafe is our therapeutic product. HerdSafe is the large-scale purification and recombinant based DNA vaccine using Adenovirus and AVV genetically engineered viruses. (PURIVAX)

HERDSOFT (Software Management)

HerdSoft is our comprehensive Johne’s disease management solution which is a web-based product connected to our data center. The management system will deliver results, collect data and incorporate environmental analysis to guide the client on therapy and management of their herd to control Johne’s disease in their facility.

DEVELOPMENTS TO DATE

HerdCheck

GeneThera hasWe have developed a molecular system for the detection of Johne’s diseaseMycobacterium Avian Paratuberculosis in the milk blood and feces of infected dairy cows infected with the Mycobacterium paratuberculosis sub. Avium. (MAP).cows. Samples from milk obtainingobtained from supermarket shelves were either “spiked’’spiked’ with different concentrations of MAPMycobacterium Avian Para tuberculosis or ‘naturally‘naturally processed.’ The bacterial DNA was isolated using both, manual and robotic- basedrobotic-based DNA extraction procedures and analyzed using The Real Timethe real time PCR technology. Using this methodology, we can detect between two (2) and twenty (20) bacterial particles from 10 ml of milk. We believe that our test will be very useful for early detection of MAPMycobacterium Avian Para tuberculosis, both in milk samples and in infected cows.

We are currently evaluating several robotic systems for DNAnucleic acid extraction. We believe that we can further increase the sensitivity of the molecular assay by using robotic driven DNA and RNA extraction methods.

HerdSoft

To date, we have developed a prototype computer program to track samples that will be received and processed in our commercial laboratory. This program will initially be used to track samples that will be sent out and received to our laboratory. We had to stop our timeline waiting for secured funding. We will then work on improving the system in order to track samples during the different phases of DNA extraction procedures. In addition, we will continue to develop a data base system to store and analyze data collected during sample analysis.

HerdSafe

We are currently developing a vaccine for Johne’s disease. GeneThera’sMAP infection. Our approach for developing this vaccine is based on the use ofour Molecular Robotic/AI Platform and Therapeutic (MORAPAT) technology which also includes our PURIVAX technology, genetically engineered Adenoviral and AVV, and silencing RNA technology (iRNA). To date, we have modified the Adenovirus by inserting a gene of the MAP bacterium responsible for triggering the infection in blood cell.CRISPR technology.

However, atAt the present time, we do not have sufficient financial resources to implement further development work; therefore, we will need to secure substantial funding to continue the development of the Johne’sMAP vaccine.

DiseaseTo date, we have developed a prototype computer program to track samples that will be received and FUTURE DEVELOPMENT PLANSprocessed in our planned commercial laboratory. This program will initially be used to track samples that will be sent out and received by our laboratory. Upon raising the additional requisite funding, of which there is no guarantee, we will then work on improving the system in order to track samples during the different phases of DNA and RNA extraction procedures. In addition, we will continue to develop a database system to store and analyze data collected during sample analysis.

Future Development Plans

We anticipate that research and development, (R&D)or R&D, will be the source for both assay development and vaccine design/development. If we are successful in developing assays for different diseases, we intend to formalize the procedure into a commercial application through a series of laboratories to be owned and operated by us. We anticipate that R&D will be ongoing during the life of the Company, as this is the source for new products to be introduced to the market. Our plan is to seek new innovations in the biotechnology field. We cannot assure that we will be successful in developing or validating any new assays or, if we are successful in developing and validating any such assays, that we can successfully commercialize them or earn profits from sales of those assays. Furthermore, we cannot assure that we will be able to design, develop, or successfully commercialize any vaccines as a result of our research and development efforts.

It is our intention to continue with the research and development and validation of the molecular tests and DNA vaccines. Future plans of the Company include initiating validation procedures for MAP and SARS-CoV-2 molecular tests.

In parallel, we will continue R&D phases for the MAP vaccine. We intend to initiate development of a SARS-CoV-2 vaccine. We plan on initiating an experimental animal protocol to determine the safety of our vaccines. Moreover, upon raising the necessary capital, we plan to initiate the experimental animal studies within 12-18 months.

Research and Development

We anticipate that R&D will be the source for both assay development and vaccine design/development. If we are able to develop assays for different diseases, we intend to formalize the procedure into a commercial application through a series of laboratories to be owned and operated by GeneThera.  To date, we

have introduced our diagnostic solution for Chronic Wasting Mad Cow Disease on a very limited basis.us. We anticipate that R&D will be ongoing during the life of the Company, as this is the source for new products to be introduced to the market. Our plan is to seek new innovations in the biotechnology field. We cannot assure you that we will be successful in developing or validating any new assays or, if we are successful in developing and validating any such assays, that we can successfully commercialize them or earn profits from sales of those assays. Furthermore, we cannot assure you that we will be able to design, develop, or successfully commercialize any vaccines as a result of our research and development efforts.

It is GeneThera’s intention to continue with the research and development and validation of the molecular tests and DNA vaccines.  Future plans comprises in initiating validation procedures for Johne’s disease molecular test. These validation protocols will be performed in our laboratory in Colorado.Marketing Strategy

In parallel, we will continue R&D phases for the Johne’s disease vaccine. We plan initiating an experimental animal protocol to determine the safety of our vaccines. We estimate that the experimental animal protocol may take up to a year. We project to initiate the experimental animal’s studies within 18-36 months.

R&D SERVICES

Molecular, Cellular, Viral Biology Research and Consulting Services:  We provide independent research services to scientists in academia, the pharmaceutical industry, and the biotechnology industry.  Primarily, GeneThera expertise focuses on technology relevant to animal and human immunotherapy.  These services are backed by the cumulative experiences of greater than 50 years of research and development in both government and industry by GeneThera senior scientists. GeneThera intends to develop a commercial-scale implementation of Adenovector Purification Process to support R&D material production. Furthermore, GeneThera intends to evaluate and test commercially available expression vectors and incorporate them into its vector repertoire.  These technologies are well established within the repertoire of GeneThera scientific staff.  We cannot provide any assurance, however, that we will be able to successfully offer these services or that, if offered, we can provide them profitably.

Research & Development Services:

Molecular Biology:

Synthetic cDNA Construction

Prokaryotic Expression Vector Construction & Development

E. coli Expression Strain Evaluation

Pilot Scale Fermentation

Mammalian Expression Vector Construction & Development

Baculovirus Expression

Protein Isolation

Protein Engineering: Complement Determining Region Conjugated Proteins

Monoclonal Antibody Production Chimerization & Humanization

Vector design for Prokaryotic Expression of Antibody Fragments (Fab) and Single Chain Antibody (ScFv)

Pilot Scale-up Development

Process Purification & Characterization

Assay Development & Quality Control Pharmaceutical Dosage and Formulation

Gene Therapy Testing Services: GeneThera offers GLP (Good Laboratory Procedure) testing programs for somatic cell, viral and naked DNA-based gene therapies.  Our scientists have over twenty years of experience in providing fully integrated bio-safety testing programs for the cell and gene therapy fields.  To date, the Company has not generated any revenues with regard to these services, and there is no assurance that we will generate any revenues from such services.

Replication-Competent Viral Vector Testing:  Sensitive in vitro cell culture assays are used to detect replication-competent retroviruses or adenoviruses.  GeneThera can work with clients to provide custom replication-competent virus detection assays for the particular vector construct.

Complete Somatic Cell and Viral Vector Packaging and Producer Cell Line Characterization:  GeneThera offers all of the assays mandated by regulatory authorities worldwide for the bio-safety analysis and characterization of cells and cell lines used in gene therapy products.

Vector Stock Characterization:  Custom purity and potency testing is available for gene therapy viral vector stocks.

Vector Purification Process Validation for Viral Clearance:  Most biopharmaceuticals require viral clearance studies to validate the removal of potential contaminants, such as those from bovine components or from helper viruses (adenovirus in AAV production).  GeneThera can provide custom design and performance of viral studies for various vector purification processes.

Custom Bio-safety Testing Programs for Somatic Cell, Ex Vivo Cell, and Tissue Therapies:  GeneThera can guide our clients through the unique process of designing and implementing a bio-safety testing program that meets the needs of each specific project.

GeneThera is currently seeking contracts for these services to be performed on an annual basis.  There is no assurance that any contracts will be signed or that the Company will generate significant revenues or profits from any such contracts.

MARKETING STRATEGY

GeneThera’s goal is to focus on both the domestic and international markets primarily Pacific Rim and Europe, for the commercialization of its animal testing platform. The company has no plans to offer any veterinary services in the United States.our MORAP and MORAPAT systems.

Our marketing approach is to align ourselves with both the private sector and government agencies.

Commercial Diagnostic Testing

SALES AND MARKETING

Our sales and marketing efforts will be primarily in Europe and Pacific Rim (New Zealand and Australia).

COMMERCIAL DIAGNOSTIC TESTING

In the event that we are able to develop assays for the detection of diseases in animals, we intend to establish a series of diagnostic testing laboratories geographically proximate to the primary sources of individual diseases and/or according to specific available operating efficiencies. The specific number of labs to be built and operated will be based on assay demand (demand facilitated by the number of specific disease assays GeneThera develops)we develop), our ability to obtain the capital to build the labs, and our ability to successfully manage them from our principal office.  As of the date of this filing, we are in negotiations to establish one diagnostic testing laboratory outside of our Colorado facility.offices.

LICENSINGLicensing

Through our licensing division, weWe intend to manage the marketing and salesales of theour vaccines developed byas through our R&D. As GeneThera doeswe do not intend to be a vaccine manufacturer, we plan to use our licensing division to license the technology related to any vaccines that may be developed and to manage the revenue potential available from the successful development and validation of specific vaccines. We cannot provide any assurance that we will develop any vaccines or that, if they are developed, we will be able to license them successfully or that any such license will produce significant revenues.

INTELLECTUAL PROPERTYIntellectual Property

We do not own any patents on any of our technology and have not filed any applications for patents in any country. We cannot give any assurance that we will be able to file any patent applications or that, if we file one or more applications for patents, any patents will issue or that, if issued, the claims granted in any such patents will afford us adequate protection against competitors with similar technology.

We believe that we own common law proprietary rights with respect to our technologies and we intend to use our best efforts to protect such rights through maintaining trade secret protections and entering into confidentiality agreements.

We also depend upon the skills, knowledge, and experience of our scientific and technical personnel, none of which is patentable. To help protect our proprietary know-how, which is not patentable, and for inventions for which patents may be difficult to endorse, we rely on trade secret protection to shield our interests.

COMPETITIONCompetition

We face competition from many companies, universities, and research institutions in the United States and abroad. Virtually all of our competitors have substantially greater resources, experience in product commercialization, and obtaining regulatory approvals

for their products, operating experience, research and development, marketing capabilities, and manufacturing capabilities that we do. We will face competition from companies marketing existing products or developing new products for diseases targeted by our technologies. The development of new products for those diseases for which we are attempting to develop products could render our product candidates noncompetitive and obsolete.

Our current competitors include primarily, Roche Diagnostics, Abbott Laboratories, IDEXX Laboratories, Inc., Academicand academic and government institutions are also carrying out a significant amount of research in the field of veterinary health, particularly in the field of Johne’s disease.zoonotic diseases. We anticipate that these institutions will become more aggressive in pursuing patent protection and negotiating licensing arrangements to collect royalties for the use of technology thattechnologies they have developed and to market commercial products similar to those that we seek to develop, either on their own or in collaboration with our competitors. Any resulting increase in the cost or decrease in the availability of technology or product candidates from these institutions may affect our business.

Competition with respect to our veterinaryrobotic technologies and potential products is and will be based, among other things, on effectiveness, safety, reliability, availability, price, and patent protection. Another important factor will be the timing of market introduction of products that we may develop and for which we may receive regulatory approval. Accordingly, the speed with which we can develop products, complete the required animal studies or trials and approval processes and ultimately supply commercial quantities of the products to the market is expected to be an important competitive factor. Our competitive position will also depend upon our ability to attract and retain qualified personnel, to obtain patent protection or otherwise develop propriety products or processes, and to secure sufficient capital resources for the often-substantial period between technological conception and commercial sales.

Several attempts have been made to develop technologies that compete with F-PCR.Real-time-PCR (RT-PCR). To our knowledge none of these technologies have resulted to date in any product available on the market. The field of biotechnology is very dynamic. The possibility that more advanced technologies could be developed into products that may compete with ours is very strong. However, it is very difficult to predict the length of time necessary for this scenario to take place.

Manufacturing

MANUFACTURING

We do not manufacture any products. We do not intend to establish a manufacturing facility to manufacture any products that we may develop anywhere in the world. We do not intent to manufacture, sell, and distribute any diagnostic or therapeutic product in the United States in the foreseeable future. 

Product Liability

PRODUCT LIABILITY

The testing, manufacturing, and marketing of the Company’sour proposed products involves an inherent risk of product liability attributable to unwanted and potentially serious health effects in animals that may receive any vaccines that we may develop and market. To the extent we elect to test, manufacture, or market veterinary vaccines and other products, we will bear the risk of product liability directly. We do not currently have product liability insurance. There is no guarantee that we can obtain product liability insurance at a reasonable cost, or at all, or that the amount of such insurance will be adequate to cover any liability that we may be exposed to. In the absence of such insurance, one or more product liability lawsuits against us can be expected to have a material adverse effect on our business and could result in our ceasing operations.

GOVERNMENT REGULATIONGovernment Regulation

Our unique approach to the testing for various animalzoonotic diseases allows us to begin commercialization of itsour diagnostic tests without the need for a long and enduring approval process from the USDA. USDA approval will be required for commercialization of animal vaccines. However, it is our intention not to seek, in the foreseeable future, any approval either from the USDA or the FDAU.S. Food & Drug Administration for any of the products we develop both, diagnostic orand therapeutic. It is our intention to perform any validation or clinical trials of our product abroadboth domestically and primarily in Europe and Pacific Rim where our commercial operation will also be located.abroad. Our commercial laboratories will require a validation study to be performed to demonstrate the effectiveness of the system. Validation studies will be performed according to each country’scountry’s guidelines. We have submitted an application outlining a protocol for animal studies. ValidationIt is expected that validation studies will be conducted in collaboration with each country’scountry’s government guidelines. We expect to communicate with the public about the validation study’s commencement and completion withinguidelines over the next 18-3618 to 36 month period. We will need the approval of the U.S. Department of Agriculture, or USDA, before the vaccines can be manufactured or sold. The approval process for animal vaccines is time-consuming and expensive. We anticipate that such approval, if it is obtained, may require more than $75 million and may require more than two years for each vaccine for which approval is sought. Currently, we do not have the capital necessary to seek approval of any of our candidate vaccines, and we cannot provide any assurance that we will be able to raise the capital necessary for such approval on terms that are acceptable to us, if at all. Failure to raise the necessary capital will likely cause us to curtail or cease operations. In addition, even if we are successful in raising the capital necessary to seek approval of any vaccine, there are no assurances that such an approval will be granted, or if granted, whether we will be able to produce and sell such vaccines following such an approval in commercial quantities or to make a profit from such production and sales.

ITEM 1A: RISK FACTORSEmployees

We encounterhad a total of two full-time employees as of December 31, 2021. No changes in full-time employees have occurred subsequently. None of our employees is represented by a collective bargaining unit.

ITEM 1A.RISK FACTORS

Investment in our common stock involves a high degree of risk. You should carefully consider each of the following risks, together with all other information set forth in this report, including the financial statements and the related notes, before making a decision to buy our common stock. If any of the following risks actually occurs, our business could be harmed. In that case, the trading price of our common stock could decline, and you may lose part or all of your investment.

Risks Related to Our Business

Our success depends on our ability to resume development of our MORAP technology.

We focused on the development of MORAP technology for zoonotic disease diagnostic detection and vaccine development. As a result, our success depends entirely on our ability to finalize the development and commercialize the of molecular robotic/AI laboratory platform. If we are unable to achieve this goal, we may not be able to earn sufficient revenue to continue our business.

Business interruptions, including any interruptions resulting from COVID-19, could significantly disrupt our operations and could have a material adverse impact on the Company if the situation continues. Under Colorado Updated Public Health Order 20-24 Implementing Stay At Home Requirements (the “Order”), GeneThera falls under the definition of a “Critical Business”, as, pursuant to the Order “Critical Business” means (1) research and laboratory services, and (2) pharmaceutical and biotechnology companies.

Further, all employees, including our specialized scientific and technical staff, are working from home or in a virtual environment. The Company always maintains the ability for team members to work virtual and we will continue to stay virtual, until the State and or the Federal government indicate the environment is safe to return to work.

The ongoing coronavirus outbreak which began in China at the beginning of 2020 has impacted various risks relatedbusinesses throughout the world, including travel restrictions and the extended shutdown of certain businesses in impacted geographic regions. If the coronavirus outbreak situation should worsen, we may experience disruptions to our business including, but not limited to equipment, to our workforce, or to our business relationships with other third parties.

The extent to which the coronavirus impacts our operations or those of our third-party partners will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, new information that may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others. Any such disruptions or losses we incur could have a material adverse effect on our financial results and our industry.  While the Company is optimistic about its long term prospects, the following risk factors should be considered in evaluating its outlook.ability to conduct business as expected.

There is aOur recurring operating losses have raised substantial doubt about GeneThera’sregarding our ability to continue as an on-goinga going concern,. and our auditors issued a “going concern” audit opinion in their report on our financial statements.

GeneThera has had negligible revenues since inception, had a negative working capital deficit and an accumulated deficit of $6,477,341 and $25,034,821, respectivelyOur independent auditors have indicated in their report on our audited consolidated financial statements as of December 31, 2015,2021, which are included in this report, that there is substantial doubt about our ability to continue as a going concern. A “going concern” opinion indicates that the financial statements have been prepared assuming we will continue as a going concern and haddo not include any adjustments to reflect the possible future effects on the recoverability and classification of assets, or the amounts and classification of liabilities that may result if we do not continue as a net lossgoing concern. As of $1,085,471this Annual Report on Form 10-K, the circumstances have not been changed, and therefore, the aforementioned going concern situation remains current. Therefore, you should not rely on our consolidated balance sheet as an indication of the amount of proceeds that would be available to satisfy claims of creditors and potentially be available for distribution to shareholders in the year ended December 31, 2015. Becauseevent of these circumstances, GeneThera will requireliquidation.

We need to raise additional working capital in 2022 to develop businesscontinue operations. There is no assurance that GeneThera will reach a level of revenues adequateIf we fail to generate sufficient cash flow from operation or

obtain additional financing, necessarywe would be forced to support GeneTheradelay the development of our MORAP or liquidate the Company.

We are a development stage company with limited operating expense requirements.history. We will need significant, additional capital to continue development of the molecular robotic/AI laboratory platform and to develop diagnostic assays and vaccine product candidates. As of December 31, 2021, we had cash and cash equivalents (excluding restricted cash) of $0 and negative working capital of $8,058,772.

Based on our current operating plan, we don’t expect that our existing cash and cash equivalents as of December 31, 2021, will enable us to maintain our operating expenses in 2022. We will need to raise additional capital in 2022 to execute our current operating plan. Securing additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to operate our business, including our ability to develop and commercialize our product candidates.

We cannot guarantee that additional capital will be available in sufficient amounts or on terms acceptable to us, if at all. If financing is available, itwe are unable to raise additional capital, when required in 2022 or thereafter in the future, or on acceptable terms, we may involve issuing securities seniorbe required to:

If we are unable to raise additional capital in sufficient amounts or on terms acceptable to use, we will be prevented from pursuing development and commercialization efforts, which will have a material adverse impact on our common stock.  business operating results and prospects, including possible liquidation of the company.

In addition, we may secure additional capital using credit facilities and other debt and may substantially increase our reliance on such debt in the eventfuture. Such debt may be secured by a portion or substantially all of our assets. If we do not raiserepay such indebtedness in a timely fashion, secured lenders could declare a default and foreclose upon our assets, which would result in harmful disruption to our business, the sale of assets for less than their fully realizable value, and possible bankruptcy. Such credit facilities also typically include several operational and financial covenants. If we fail to comply with the covenants and our other obligations under any credit facility, the secured lenders would be able to accelerate the required repayment of amounts due and, if they are not repaid, could foreclose upon our assets, which would result in harmful disruption to our business, the sale of assets for less than their fully realizable value, and possible bankruptcy. In addition, future credit facilities may limit our ability to incur incremental debt without our lenders’ permission.

Future sales and issuances of our common stock or rights to purchase common stock by us will result in additional dilution of the percentage ownership of our shareholders and may cause our share price to decline.

Until such time, if ever, as we can generate substantial product revenues, we expect that significant additional capital will be needed to continue our planned operations, including securing regulatory approvals, commercialization efforts, expanding research and development activities and costs associated with operating as a public company. We may sell shares of our common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner that we determine from conventional sources, such astime to time. If we sell shares of our common stock, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales. Such sales may also result in material dilution to our existing investorsshareholders and new investors. In addition, new shareholders could gain rights superior to our existing shareholders.

We have identified material weaknesses in our internal control over financial reporting. If we fail to develop or commercial banks, there ismaintain an effective system of internal controls, we may not be able to accurately report our financial results and prevent fraud. As a likelihoodresult, current and potential shareholders could lose confidence in our financial statements, which would harm the trading price of our common shares.

We are subject to the requirements of Section 404 of the Sarbanes-Oxley Act of 2002, or SOX 404. SOX 404 requires management to establish and maintain a system of internal control over financial reporting and annual reports on Form 10-K filed under the Securities Exchange Act of 1934, as amended, or the Exchange Act, to contain a report from management assessing the effectiveness of a company’s internal control over financial reporting. During its evaluation of the effectiveness of internal control over financial reporting, the Company’s management identified material weaknesses. These material weaknesses were associated with our lack of sufficient accounting resources and internal personnel with GAAP knowledge. We are undertaking remedial measures, which measures will take time to implement and test, to address these material weaknesses. We cannot assure you that our growthsuch measures will be restrictedsufficient to remedy the material weaknesses identified or that additional material weaknesses or other control or significant deficiencies will not be identified in the future. If we continue to experience material weaknesses in our internal controls or fail to maintain or implement required new or improved controls, such circumstances could cause us to fail to meet our periodic reporting obligations or result in material misstatements in our financial statements, or adversely affect the results of periodic management evaluations and, weif required, annual auditor attestation reports. Each of the foregoing results could cause investors to lose confidence in our reported financial information and lead to a decline in our stock price.

Our technology is not protected by patents.

Our technology and know-how are not patented. We rely on trade secret protections and confidentiality agreements to protect our intellectual property. We cannot assure you that these trade secrets and confidentiality agreements will provide meaningful protection for our intellectual property. Furthermore, in absence of patent protection, competitors who independently develop substantially equivalent technology may be forced to scale back or curtail implementingharm our business plan.business.

If a Loss of Key Personnel Will Occur This Event Could Adversely Affectkey personnel will adversely affect the Company.

The Company depends to aWe depend in large part on the efforts and continued employment of Dr. Antonio Milici, M.D., Ph.D., our President, Chairman and Chief Executive Officer. The loss of Dr. Milici willwould have a material adverse effect on theour business, results of operations (if any) and financial condition of the Company.condition. In addition, the loss of Dr. Milici maywould force the Companyus to seek a replacement, who may have less experience, fewer contacts, or less understanding of the business. Further, we may be unable to find a suitable replacement for Dr. Milici, which could force the Company to curtail its operations and/or cause any investment in the Company to become worthless.  The Company has an employment agreement with Dr. Milici, which ends on January 7, 2017.

If theCompany fails to attract and retain additional highly skilled personnel, operations will suffer.

Milici. Finding qualified personnel in the biotechnology industry is very challenging.challenging, but feasible. Smaller biotechnology companies are alwayspotentially at a disadvantage because of itsin the employment marketplaces due to their limited financial resources. The Company has been unable at this time to hire any additional qualified personnel. If the Company is unable to hire additional personnel, this may resultresources; something like reliable funding can resolve with ease. Dr. Milici continues interviewing highly experienced scientists in a substantial delay of its R&Dmolecular biology and commercial operations.

If the Company fails to attract significant additional capital, the Company may be unable to continue developing its products.

From the beginning of its operation, GeneThera has obtained limited funding to implement its business strategy. The Company believes it will require significant additional fundingrobotic engineers in order to achieve its business plan.  Over the next 12 months, in order to have the capability of achieving its business plan, the Company will require at least $10,000,000 in additional funding.  There are no guarantees that the Company will be able to secure such financing, and if the financing is secured, there are no guarantees whether the Company can fully achieve the goals laid out in its business plan. If financing is available, it may involve issuing securities senior toexpanding our common stock.  In addition, in the event we do not raise additional capital from conventional sources, such as our existing investors or commercial banks, there is a likelihood that our growth will be restricted and we may be forced to scale back or curtail implementing our business plan.

Rapid growth may place significant demands on our resources.

We expect significant expansion of our operations, funding permitting, moving forward. Our anticipated future growth will place a significant demand on our managerial, operational and financial resources due to:

* The need to manage relationships with various strategic partners and other third parties.

* Difficulties in hiring and retaining skilled personnel necessary to support our business.

* The need to train and manage a growing employee base.

* Pressures for the continued development of our financial and information management systems.

If we have not made adequate allowances for the costs and risks associated with this expansion or if our systems, procedures, or controls are not adequate to support our operations, our business could be harmed.

current projects globally.

 The Company may not be able to comply with Government regulations.

The Company is subject to or affected by laws and regulations that govern, for example: the vaccination of animals for certain diseases.  The failure to comply with these laws and regulations, or to obtain applicable governmental approvals, could result in the imposition of penalties, cause delays in, or make impossible, the marketing of our products and services.

The CompanyWe may be unable to compete against other more establish biotech of pharmaceuticalbiotechnology companies.

The Company operatesWe operate in a verycompetitive and difficult area. Biotechnology business is notoriously challenging and risky. The Company competesWe compete with other more established and better funded companies in the United States and overseas that are involved in the development of similar products. Several of these companies have significantly greater financial resources as well as greater production and marketing capabilities. The field of Biotechnologybiotechnology requires extensive research and development. Better funded competitors may be able to develop and market superior or less expensive products whichthat will make the Company’sour products less valuable or unmarketable.unmarketable unless we acquire reliable funding from trustworthy investors in order to have an excellent advantage to succeed with our competitors.

The Company has limited Government Regulatory Experience.

The Company has never successfully undertaken a clinical trial for animal testing. Our experience in this area is limited. The Company has never obtained regulatory approvals for any of its products.  As such, the Company may be unable to ever successfully undertake a clinical trial of its products, and may be forced to curtail or abandon its current business plan.

The Company has a history of operating losses.

We have generated no revenues to date from our operations. Historically, we have had net operating losses each year since our inception. Additionally, even if we are able to commercialize our technology or any products, it is not certain that will result in revenues or profitability.

The Company relies on third parties for sale, distribution and manufacturing.

We do not have any “in house” sale, distribution or manufacturing capabilities. The success of our operations mostly depends by the ability of marketing entities.

.

The Company has a limited operating history on which investors may evaluate our operation and prospects for profitable operations

If we continue to suffer losses as we have in the past, investors may not receive any return on their investments. Our prospects must be consider speculative in light of the risks, expenses and difficulties frequently encountered by companies in their early stages of development. A substantial risk is involved in investing in the company because we have fewer resources than established companies.

The company depends on new and rapidly evolving technologies

We are engaged in activities in the biotechnology field, which is characterized by extensive research effort and rapid technological progress. If we fail to anticipate or respond adequately to technological developments, our ability to operate profitably could suffer. We cannot assure that research and discoveries by other biotechnology, agriculture, pharmaceutical or other companies will not render our technologies or products uneconomical or result in products superior to those we develop, depend on new and evolving technologies. If theseour technologies do not produce satisfactory results, our business may be harmed.

OverIncreased competition from and technological advances by our competitors could negatively affect our operating results.

We face intense competition, and we expect that future competition may become even more intense as new products, services and technologies become available and other new competitors enter the last year we have narrowedmarket. Competition could negatively affect our potential product development to focus on the molecular testingsales and profitability in a number of Johne’s disease.

Due to the increase cost of R&D and the very challenging economic environment we have decided to concentrateways. Other new competitors may enter our efforts inmarkets through the development of innovative new technology, the acquisition of rights to use existing technologies or the use of existing technologies when patents protecting such existing technologies expire. New or existing competitors may introduce new, innovative, and competitive products and services, which could be superior or perceived by our customers to be superior to our products and services or lead to the obsolescence of one or more of our products or services. Some of our competitors and potential competitors may choose to differentiate themselves by offering products and services perceived in the eyes of customers as similar, at substantially lower sales prices, which could have an adverse effect on our results of operations through loss of market share or a commercial platformdecision to lower our own sales prices to remain competitive. In addition, our ability to attract and retain customers depends on the effectiveness of our customer marketing and incentive programs and multiple competitors could bundle product and service offerings through co-marketing or other arrangements, which could enhance their ability to compete with our broad product and service offering. Certain of our competitors and potential competitors, have substantially greater financial and managerial resources than us, as well as greater experience in manufacturing, marketing, research and development, and obtaining regulatory approvals than we do. Once we secure reliable funding, we can increase our success astronomically.

Changes in testing patterns could negatively affect our operating results.

The market for our products could be negatively impacted by a number of factors impacting diagnostic assaying practices. Market acceptance of vaccines or preventatives for the diseases and conditions for which we sell diagnostic assays and services could result in a decline in testing. Changes in accepted medical protocols regarding the diagnosis of Johne’s disease.certain diseases and conditions could have a similar effect. Eradication or substantial declines in the prevalence of certain diseases also could lead to a decline in diagnostic assaying for such diseases. Changes in government regulations or in the availability of government funds available for monitoring programs could negatively affect sales of our products. In addition, changes and trends in local food markets around the world could negatively affect the related production markets resulting in a decline in demand for our diagnostic assaying products. Declines in testing for any reason could have an adverse effect on our results of operations. As a result,we can attest, the success of the company depends entirely on being able to commercializemarket for our product. Ifproducts is in high demand and we are unableeager to achieveimprove the healthcare of both humans and animals.

Various U.S. and foreign government regulations could limit or delay our ability to market and sell our products or otherwise negatively impact our business.

Our business is subject to numerous states, federal and international rules and regulations. Several of these regulations may require that we obtain approval from the related governmental agency prior to the marking or sale of our products. Delays in obtaining regulatory approvals for new products or product upgrades could have a negative impact on our growth and profitability.

We have never successfully undertaken a clinical trial for animal testing. Our experience in this goal, the Company’s operations could greatly suffer and any investment in the Company could be lost.

The Company may not obtain foreignarea is limited. We have never obtained regulatory approval to marketapprovals for any of our products.

If As such, we failmay be unable to obtain regulatory approvalever successfully undertake a clinical trial of any of our products, we will not be permitted to market our products and may be forced to cease operations.curtail or modify our current business plan.

Our technology is not protectedIn addition, the manufacture, import, and sale of our products, as well as our research and development processes, may be subject to similar or more stringent laws in other countries. Compliance with these regulations may require the expenditure of significant time and resources by patents.

Our technologythe Company, and know-how is not patented. We rely on trade secrets to protectcould require the registration, redesign or reformulation of our intellectual property. We cannot assure, however, that these trade secrets will provide meaningful protection for our intellectual property. Furthermore, in absence of patent protection, competitors who independently develop substantially equivalent technology may harm our business.  

The Company may not be able to raise the required capital to conduct our operations and develop and commercialize our products.

We require substantial additionalresourcesproducts in order to conduct our operationsconform. Any redesign or reformulation or restricted supply of parts and develop and commercializecomponents may negatively affect the availability or performance of our products and runservices, add assaying lead-times for products and reformulated products, reduce our facilities. We will need significant additional funds or a collaborative partner, or both, finance research and development activities of our potential products. Accordingly, we are continuing to pursue additional sources of financing. Additional financing through strategic collaborations, public or private equity financing sources may not be available on accepted terms. Additionally, equity financing couldmargins, result in significant dilutionadditional costs, or have other similar effects. Any of these could adversely affect our business, financial condition, or results of operations. These legal and regulatory requirements are complex and subject to our shareholders. Further, if additional funds are obtained through arrangements with collaborative partners, these arrangementschange, and we continue to evaluate their impact. Additionally, foreign governments may require us to relinquish rightsregister our products, and these product registration requirements, which vary among the applicable jurisdictions and change from time to some of our technologies, or productstime, are often complex and require us to engage in lengthy and costly processes. We cannot assure you that we would otherwise seekwill be able to develop and commercialize on our own. If sufficient capital is not available, we may beobtain or maintain any product registration required to delay, reduce the scope of or eliminateby one or more offoreign governments. Any inability to obtain or maintain a required product registration in a jurisdiction could adversely affect our programs or potential products any ofability to market and sell the applicable product in that jurisdiction, which could have a material adversenegative effect on our business, financial condition or business prospectand results of operations.

We have incurred,are also subject to a variety of federal, state, local, and expectinternational laws and regulations, as well as the associated legal and political environments, concerning, among other things, the importation and exportation of products; our business practices in the U.S. and abroad, such as anti-corruption, anti-money laundering, and anti-competition laws; and immigration and travel restrictions. These legal, regulatory, and political requirements and environments differ among jurisdictions around the world and are rapidly changing and increasingly complex. The costs associated with compliance with these legal and regulatory requirements and adjusting to continuechanging legal and political environments are significant and likely to incur, increased costsincrease in the future.

Any failure by us to comply with applicable legal and risksregulatory requirements, or to adjust to changing legal and political environments, could result in fines, penalties, and sanctions; product recalls; suspensions or discontinuations of, or limitations or restrictions on, our ability to design, manufacture, market, import, export or sell our products; and damage to our reputation. Any of these could negatively impact our business.

Future operating results could be negatively affected by changes in tax rates, the adoption of new U.S. or international tax legislation or exposure to additional tax liabilities.

We are subject to local, state, regional and federal tax laws in jurisdictions around the world. Our future tax expense could be affected by changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities or changes in tax laws or their interpretation. Additionally, tax rules governing cross-border activities are continually subject to modification as a result of being a public company.both coordinated actions by governments and unilateral measures designed by individual countries, both intended to tackle concerns over base erosion and profit shifting and perceived international tax avoidance techniques.

AsOur income tax filings may become subject to an audit by various tax authorities, and the final determination of tax audits could be materially different than that which is reflected in historical income tax provisions and accruals. Significant judgment is required in determining our provision for income taxes. We assess our exposures related to our provision for income taxes to determine the adequacy of our provision for taxes. Any reduction in these contingent liabilities or additional assessments would increase or decrease income, respectively, in the period such determination is made.

Natural and other disasters, information technology system failures and network disruptions and cybersecurity breaches and attacks could adversely affect our business.

Our business and results of operations could be negatively affected by certain factors beyond our control, such as natural disasters and/or climate change-related events (such as hurricanes, earthquakes, fires, and floods); civil unrest; negative geopolitical conditions and developments; war, terrorism, or other man-made disasters; and information technology system failures, network disruptions and cybersecurity breaches and attacks. Any of these events could result in, among other things, damage to or the temporary closure of our facilities; a public company, we are requiredtemporary lack of an adequate work force in one or more markets; an interruption in power supply; a temporary or long-term disruption in our supply chain (including a disruption to comply withour ability to obtain critical components for the Sarbanes-Oxley Actdevelopment of 2002,our product candidates); and short- or SOX,long-term damage to our prospective customers’ businesses (which would adversely impact demand for our products and services).

We rely on our own information systems, as well as rulesthose of our third-party business partners and regulations implementedsuppliers. Despite the introduction of system backup measures and engage in information system redundancy planning and processes, such measures, planning and processes may be ineffective or inadequate to address all eventualities. Further, our information systems and our business partners’ and suppliers’ information systems may be vulnerable to attacks by hackers and other security breaches, including computer viruses and malware, through the SEC. Changesinternet (including via devices and applications connected to the internet), email attachments and persons with access to these information systems, such as our employees or third parties with whom we do business. As information systems and the use of software and related applications by us, our business partners, suppliers, and customers become more cloud-based and connected to the internet, there has been an increase in global cybersecurity vulnerabilities and threats, including more sophisticated and targeted cyber-related attacks that pose a risk to the lawssecurity of our information systems and regulations affecting public companies, includingnetworks and the provisionsconfidentiality, availability and integrity of SOXdata and rules adopted byinformation. Any such attack or breach could compromise our networks and the SEC, have resulted in,information stored thereon could be accessed, publicly disclosed, lost, or stolen.

If we or our business partners or suppliers were to experience a system disruption, attack or security breach that impacts any of our critical functions, or our customers were to experience a system disruption, attack or security breach via any of our connected products and will continue toservices, it could result in increased costs to us as we respond to these requirements. Given the risks inherent in the design and operationa period of internal controls over financial reporting, the effectivenessshutdown of our internal controls over financial reporting is uncertain. If our internal controls are not designed or operating effectively,information systems during which we may not be able to issue an evaluationoperate, the loss of sales and customers, financial misstatement, potential liability for damages to our customers, reputational damage and significant incremental costs, which could adversely affect our business, results of operations and profitability. Furthermore, any access to, public disclosure of, or other loss of data or information (including any of our internal control over financial reportingconfidential or proprietary information or personal data or information) as requireda result of an attack or wesecurity breach could result in governmental actions or private claims or proceedings, which could damage our independent registered public accounting firm may determine thatreputation, cause a loss of confidence in our internal control over financial reporting was not effective. In addition,products and services, damage our registered public accounting firm may either disclaim an opinion as it relatesability to management’s assessment of the effectivenessdevelop (and protect our rights to) our proprietary technologies and adversely affect our business.

Risks Related to Ownership of our internal controls or may issue an adverse opinionCommon Stock

Our common stock is quoted on the effectivenessOTC Markets, which may have an unfavorable impact on our stock price and liquidity.

Our common stock is quoted on the OTC Markets under the symbol “GTHR.” The OTC Markets is a significantly more limited market than the New York Stock Exchange or the NASDAQ stock market. The quotation of our internal controls over financial reporting. Investorsshares on the OTC Markets may lose confidenceresult in the reliabilitya less liquid market available for existing and potential stockholders to trade shares of our financial statements,

whichcommon stock, could causedepress the markettrading price of our common stock to decline and which could affecthave a long-term adverse impact on our ability to run our business as we otherwise would like to. New rules could also make it more difficult or costlier for us to obtain certain types of insurance, including directors’ and officers’ liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtainraise capital in the coverage that is the same or similar to our current coverage. The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our Board of Directors, our board committees, and as executive officers. future.

We cannot predict the extent to which an active public trading market for our common stock will develop or estimatebe sustained. If an active public trading market does not develop or cannot be sustained, you may be unable to liquidate your investment in our common stock.

Currently there is minimal public trading in our common stock. We cannot predict the total amountextent to which an active public market for our common stock will develop or be sustained due to a number of factors, including the costsfact that we may incurare a small company that is relatively unknown to stock analysts, stock brokers, institutional investors, and others in the investment community that generate or influence sales volume, and that even if we came to the timingattention of such costspersons, they tend to comply with these rulesbe risk-averse and regulations.would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares of common stock until such time as we became more seasoned and viable. As a consequence, there may be periods of several days or more when trading activity in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price. We cannot assure you that an active public trading market for our common stock will develop or be sustained. If such a market cannot be sustained, you may be unable to liquidate your investment in our common stock.

Compliance with Section 404 of the Sarbanes-Oxley Act will continue to strain our limited financial and management resources.

We incur significant legal, accounting and other expenses in connection with our status as a fully reporting public company. The Sarbanes-Oxley Act and new rules subsequently implemented by the SEC have imposed various new requirements on public companies, including requiring changes in corporate governance practices. As such, our management and other personnel need to devote a substantial amount of time to these new compliance initiatives. Moreover, these rules and regulations have increased our legal and financial compliance costs and made some activities more time-consuming and costly. In addition, the Sarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for financial reporting and disclosure of controls and procedures. Our testingcommon stock may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses. Our compliance with Section 404 requires that we incur substantial accounting expense and expend significant management efforts. We may need to hire additional accounting and financial staff with appropriate public company experience and technical accounting knowledge.  Moreover, if we are not able to comply with the requirements of Section 404 in a timely manner, or if we or our independent registered public accounting firm identifies deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses, the market price of our stock could decline, and we could be subject to sanctions significant price volatility, which may have an adverse effect on your ability to liquidate your investment in our common stock.

The market for our common stock may be characterized by significant price volatility when compared to seasoned issuers, and we expect that our share price will 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, our shares of common stock may be sporadically and/or investigationsthinly traded. As a consequence of this lack of liquidity, the trading of relatively small quantities of shares by our stockholders may disproportionately influence the price of those shares in either direction. The price for our shares could, for example, decline precipitously in the event that a large number of our shares of common stock are sold on the market without commensurate demand, as compared to a seasoned issuer that could better absorb those sales without adverse impact on its share price. Secondly, an investment in us may be considered a speculative investment due to our lack of profits to date and uncertainty of future profits. As a consequence of this enhanced risk, more risk-adverse 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.

We are subject to penny stock regulations and restrictions and you may have difficulty selling shares of our common stock.

The United States Securities and Exchange Commission, or SEC, has adopted regulations which generally define so-called “penny stocks” to be an equity security that has a market price less than $5.00 per share or other regulatory authorities, which would require additional financial and management resources.

Investors May Face Significant Restrictions On The Resale Of Our Common Stock Due To Federal Regulations Of Penny Stocks.

an exercise price of less than $5.00 per share, subject to certain exemptions. Our common stock will beis a “penny stock” and is subject to the requirements of Rule 15g-9, promulgatedor the Penny Stock Rule, under the Securities Exchange Act of 1934, as long asamended, or the price of our common stock is below $5.00 per share. UnderExchange Act. This rule imposes additional sales practice requirements on broker-dealers that sell such rule, broker-dealers who recommend low-priced securities to persons other than established customers and accredited investors“accredited investors” (generally, individuals with a net worth in excess of $1,000,000 or annual incomes exceeding $200,000, or $300,000 together with their spouses). For transactions covered by the Penny Stock Rule, a broker-dealer must satisfymake a special sales practice requirements, including a requirement that they make an individualized written suitability determination for the purchaser and receivehave received the purchaser'spurchaser’s written consent to the transaction prior to sale. As a result, this rule may affect the transaction. The Securities Enforcement Remedies and Penny Stock Reform Actability of 1990, also requires additional disclosure in connection with any trades involving a stock

defined as a penny stock. Generally, the Commission defines a penny stock as any equity security not traded on an exchange or quoted on NASDAQ that has a market price of less than $5.00 per share. The required penny stock disclosures include the delivery, priorbroker-dealers to any transaction, of a disclosure schedule explaining the penny stock market and the risks associated with it. Such requirements could severely limit the market liquidity of thesell our securities and may affect the ability of purchasers to sell theirany of our securities in the secondary market.market, thus possibly making it more difficult for us to raise additional capital.

In addition, various state securities laws impose restrictions on transferring "penny stocks"For any transaction involving a penny stock, unless exempt, the rules require delivery, prior to any transaction in penny stock, of a disclosure schedule prepared by the SEC relating to the penny stock market. Disclosure is also required to be made about sales commissions payable to both the broker-dealer and as a result, investorsthe registered representative and current quotations for the securities. Finally, monthly statements are required to be sent disclosing recent price information for the penny stock held in the common stock may have their ability to sell their shares ofaccount and information on the common stock impaired.limited market in penny stock.

Shareholders May Be Diluted Significantly Through Our Efforts To Obtain Financing And Satisfy Obligations Through The Issuance Of Additional Shares Of Our Common Stock.We cannot assure you that our common stock will qualify for exemption from the Penny Stock Rule. In any event, even if our common stock were exempt from the Penny Stock Rule, we would remain subject to Section 15(b)(6) of the Exchange Act, which gives the SEC the authority to restrict any person from participating in a distribution of penny stock, if the SEC finds that such a restriction would be in the public interest.

We have never paid cash dividends on our stock and do not intend to pay dividends for the foreseeable future.

We have paid no committed sourcecash dividends on any class of financing. Wherever possible, our Boardstock to date, and we do not anticipate paying cash dividends in the near term. For the foreseeable future, we intend to retain any earnings to finance the development and expansion of Directors will attempt to use non-cash consideration to satisfy obligations. In many instances,our business, and we believe that the non-cash consideration will consist of restricted shares ofdo not anticipate paying any cash dividends on our common stock. Our BoardAccordingly, investors must be prepared to rely on sales of Directors has authority, without action or vote of the shareholders,their common stock after price appreciation to issue all or part of the authorized but unissued shares ofearn an investment return, which may never occur. Investors seeking cash dividends should not purchase our common stock. In addition, if a trading market develops for our common stock, we may attemptAny determination to raise capital by selling sharespay dividends in the future will be made at the discretion of our common stock, possibly at a discount to market. These actionsboard of directors and will result in dilutiondepend on our results of the ownership interests of existing shareholders, may further dilute common stock book value,operations, financial condition, contractual restrictions, restrictions imposed by applicable law and that dilution may be material. Such issuances may also serve to enhance existing management’s ability to maintain control of the Company because the shares may be issued to parties or entities committed to supporting existing management.

The market price ofother factors our common stock historically has been volatile.board deems relevant.

The marketFluctuations in our quarterly or annual results may cause our stock price to decline.

Our operating results could fluctuate due to a number of factors, including changes in our common stock historically has fluctuatedaccounting estimates; litigation and claim-related expenditures; increase in the number and type of competitors; changes in competitors’ product offerings; and other matters. Similarly, our future operating results may vary significantly based on, but not limitedfrom quarter to suchquarter or year to year due to these and other factors, as general stock market trends, announcementsmany of developments related towhich are beyond our business, actual or anticipated variations incontrol. If our operating results and our ability or inability to generate new revenues.

Our common stock is traded onprojections of future operating results do not meet the OTC pink market under the symbol “GTHR.” In recent years, the stock marketexpectations of securities analysts or investors in general has experienced extreme price fluctuations that have oftentimes been unrelated to the operating performance of the affected companies. Similarly, the market price of our common stock may fluctuate significantly based upon factors unrelated or disproportionate to our operating performance. These market fluctuations, as well as general economic, political and market conditions, such as recessions, interest rates or international currency fluctuations may adversely affect the market price of our common stock.

We currently have a sporadic, illiquid, volatile market for our common stock, and the market for our common stock may remain sporadic, illiquid, and volatile in the future.

We currently have a highly sporadic, illiquid and volatile market for our common stock, which market is anticipated to remain sporadic, illiquid and volatile in the future and will likely be subject to wide fluctuations in response to several factors, including, but not limited to:

·

actual or anticipated variations in our results of operations;

·

our ability or inability to generate revenues;

·

the number of shares in our public float;

·

increased competition; and

·

conditions and trends in the market for our services.

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

ITEM 1B.UNRESOLVED STAFF COMMENTS

None.

ITEM 2:2.PROPERTIES

DESCRIPTION OF PROPERTY

We sub-lease 1,800 square feet for our administrative office, which is located at 9101 Harlan Street Suite 130 in Westminster, Colorado 80031. The lease is for 38 months and it terminates on January 31, 2018.  The rent was no cost during Months 1 and 2; Months 3-14, the rent was $2,394.75 per month; Months 15-26 months, the rent is $2,472.52; Months 27-38, the rent will be $2,549.25 per month. We sub-leased 500 square feet of office space to GTI Corporate Transfer Agents, LLC, and a related party, located in Suite 130-D.  The lease is on a three-year basis and the rent is $500 per month until January 2018.  Moreover, we may sub-lease laboratory and office space for several biotechnology and holdings companies. These lessees will have their lab equipment in our new laboratory space for their research and development work. The Company is permitted to utilize their lab equipment, which will enhance the R&D collaboration among scientific peers. We do not own any real estateproperties. We have a temporary lease for office space.

ITEM 3.LEGAL PROCEEDINGS

From time to time, we may be involved in litigation relating to claims arising out of our operations. We are not currently a party to, and our property is not subject to, any material legal proceedings.

ITEM 4.MINE SAFETY PROCEDURES

Not applicable.

PART II

ITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.

Market Information

Our common stock currently eligible for quotation on the OTC Markets under the symbol “GTHR.” The following table sets forth, for the periods indicated, the high and low closing prices of our common stock as reported by OTC Markets, Inc. These prices reflect inter-dealer prices, without retain mark-up or commission, and may not represent actual transactions.

Holders of yet.our Common Stock

As of December 31, 2021, there were approximately 286 holders of record of our common stock. This number excludes the shares owned by stockholders holding shares under nominee security position listings.

Dividends

We have not declared or paid a cash dividend. We currently intend to retain and use any future earnings for the development and expansion of our business and do not anticipate paying any cash dividends in the foreseeable future, if at all. Any future determination to declare dividends will be made at the discretion of our board of directors and will depend on our financial condition, operating results, capital requirements, general business conditions and other factors that our board of directors may deem relevant.

Securities Authorized for Issuance under Equity Compensation Plans

We do not have any compensation plans under which our securities are authorized for issuance.

Recent Sales of Unregistered Securities

We did not sell any unregistered securities during the year ended December 31, 2021.

Purchases of Equity Securities by Issuer and Affiliated Purchasers

There were no purchases of our common stock by us or on our behalf, or by or on behalf of any of our affiliates, during the year ended December 31, 2021.

ITEM 6.SELECTED FINANCIAL DATA

As a smaller reporting company, the Company is not required to provide the information under this item.

ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and result of operations should be read in conjunction with our financial statements and the notes thereto and the other financial information appearing elsewhere in this report on Form 10-K. This discussion contains forward-looking statements that relate to future events or our future financial performance. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These risks and other factors include, among others, those listed under “Forward-Looking Statements” and “Risk Factors” and those included elsewhere in this report. Our financial statements are prepared in U.S. dollars and in accordance with United States generally accepted accounting principles, or GAAP.

Overview

We continue to be a biotechnology company dedicated to eradicating “cross-over” zoonotic diseases, such as COVID-19 (Coronavirus), Paratuberculosis (Johne’s disease), Mad Cow Disease, Chronic Wasting Disease, E.coli and Salmonella infections, by applying our advanced proprietary molecular sciences and robotic technologies. We focus on developing molecular diagnostic tests, therapeutics, and vaccines through our proprietary robotic technologies with the belief that improved technologies and methodologies must be developed and implemented in order to aid mankind’s control of emerging diseases in animals and in humans. We believe it has become increasingly evident that, if not properly addressed, diseases in animals may continue to cause serious and growing global problems with respect to economics, human health and biodiversity.

We previously developed proprietary diagnostic assays for use in the agricultural and veterinary markets, and we are currently developing proprietary, genetics-based diagnostic assays and vaccine solutions through our robotic technologies with the goal of controlling the spread of zoonotic infection in the human population. Our mission is to continually apply our scientific research to the more effective management of zoonotic diseases and, in so doing, realize the commercial potential of our molecular biotechnologies.

We will require significant additional funding in order to implement and achieve our business plan. There is no guarantee that we will be successful in securing the required financing, and if such financing is secured, there is no guarantee that we will fully achieve our business goals. We provide a comprehensive solution that allows diagnosing, treating and managing zoonotic diseases in animals and humans.

Our business model is based on the development of a proprietary Molecular Robotic/AI Laboratory Platform (“MORAP”), which would combine the use of advanced robotic laboratory systems integrated with AI software systems on a global scale. Upon development, MORAP would encompass a nationwide network of interactive molecular laboratories operated using advanced integrated robotic and machine learning cloud-based software systems, which would be able to share data and interact with each other. We believe MORAP would be capable of processing millions of samples and collecting, storing and analyzing data. We believe that MORAP nationwide communications network could be accomplished through advanced cloud-based software systems, machine learning and Internet-of-Things (IoT) networks. Upon development, MORAP could be readily replicated and scaled utilizing identical instrumentation and software.

Our proprietary Molecular Robotic and Therapeutic Platform (MORAPAT) is designed to prevent the spread of disease from animals and; at the same time, allow to better control of zoonotic infectious agents. More importantly, we believe that our platform can prevent the spread of viruses and bacteria in animals and /or food products and subsequent infection of human population. We have developed a molecular system for the detection of Mycobacterium Avian Paratuberculosis in the milk of infected dairy cows.

To date, we have developed a prototype computer program to track samples that will be received and processed in our commercial laboratory. This program will initially be used to track samples that will be sent out and received by our laboratory. We anticipate that research and development, or R&D, will be the source for both assay development and vaccine design/development. If we are able to developsuccessful in developing assays for different diseases, we intend to formalize the procedure into a commercial application through a series of laboratories to be owned and operated by GeneThera.  Currently, we are setting our new laboratory space. Forthcoming through our investors, we will have the funds to purchase or construct new laboratories. It will take time; therefore, the Company opted to lease a 7,900 sf lab space while the 27,000 sf laboratory building is completed when the funds are secured for such laboratory. On May 28, 2015, our CEO and CFO met for mediation with the owner’s legal team for a reasonable settlement for

past due rent, for a past landlord, please see Item 3 for a more detailed discussion of this mediation.

ITEM 3:

LEGAL PROCEEDINGS

The Company is involved in claims arising during the ordinary course of business resulting from disputes with vendors and stockholders over various contracts and agreements.

On August 12, 2015, the Company entered into a settlement agreement with Litchfield Church Ranch, LLC (“LCR”), and its former landlord, related to back rent in the amount of $325,000.  The Company is required to pay $15,000 on or before September 12, 2015 as a good-faith down payment, on August 21, 2015, the Company paid $13,348 towards this down payment. The Company, at its option, can satisfy the judgment in the following ways and as of March 31, 2016, no payments had been made toward the settlement:

·

If paid on or before February 12, 2016, the judgment shall be deemed paid-in-full if the Company delivers $100,000 to LCR

·

If not paid off prior to February 12, 2016, the Company judgment shall be deemed satisfied if the Company delivers $150,000 to LCR on or before August 12, 2016.

·

If not paid off prior to August 12, 2016, there will be no discount and the Company shall owe the judgment balance in the amount of $325,885

In June 2009, James Tufts filed a complaint at the Small Claims Court in Jefferson County CO in the amount of $4,000 plus expenses from a London trip. The Company has not satisfied the judgment.

On June 26, 2009, Enterprise Leasing Company of Denver filed a Civil Judgment at the Jefferson County District Court in the State of Colorado in the amount of $78,178. The Company has not satisfied the judgment.

On August 17, 2010, Banc of America Leasing filed a Civil Judgment at the Oakland County District in Troy, Michigan in the amount of $24,002. The Company has not satisfied the judgment.

On September 23, 2010, Liberty Acquisitions filed a Civil Judgment at the Jefferson County Court in the State of Colorado in the amount of $3,300. The Company has not satisfied the judgment.

On February 10, 2009, Centennial Credit Corporation filed a Civil Judgment at the Jefferson County Court in the amount of $967. The Company has not satisfied the judgment.

On August 29, 2011, GeneThera had a court hearing concerning a litigation filed by The Park III related to unpaid rent according to the lease agreement. The District Court of

Boulder entered a judgment against the Company in the amount of $77,000. The Company has not satisfied the judgment.

On November 26, 2012, the Internal Revenue Service filed a Federal Tax Lien in the amount of $1,275. The Company has not satisfied the lien.

ITEM 4:

 MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5:

MARKET FOR COMMON EQUITY, RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.

Our common stock currently trades on the OTC Pink Market under the symbol “GTHR”. The following sets forth the rank of high and low bid quotations for the periods indicated. Such quotations reflect prices between dealers, without retail markup, markdown or commission, and may not represent actual transactions.

ITEM 6:

SELECTED FINANCIAL DATA

Not applicable for smaller reporting companies.