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20/20 GeneSystems, Inc

Artificial intelligence-powered diagnostics for cancer & COVID-19

20/20 GeneSystems, Inc is offering securities through the use of an Offering Statement that has been qualified by the Securities and Exchange Commission under Tier II of Regulation A. A copy of the Final Offering Circular that forms a part of the Offering Statement may be obtained both here and below. This profile may contain forward-looking statements and information relating to, among other things, the company, its business plan and strategy, and its industry. These statements reflect management’s current views with respect to future events based on information currently available and are subject to risks and uncertainties that could cause the company’s actual results to differ materially. Investors are cautioned not to place undue reliance on these forward-looking statements as they are meant for illustrative purposes and they do not represent guarantees of future results, levels of activity, performance, or achievements, all of which cannot be made. Moreover, no person nor any other person or entity assumes responsibility for the accuracy and completeness of forward-looking statements, and is under no duty to update any such statements to conform them to actual results.


Company Highlights

  • Cancer screening test orders doubled from Q3 to Q4 of 2019 (unaudited)
  • After launching in March 2020, sold over 70,000 COVID-19 antibody tests within 60 days of pandemic emergency and generated over $1.2 million in revenue
  • Procured $2 million strategic investment from Ping An, one of the world’s largest insurance and healthcare companies and were one of only 11 companies admitted to Ping An Cloud Accelerator out of over 400 applicants worldwide
  • Raised over $5.5 million from Equity Crowdfunding prior to the current Series C round
  • Launched real-world data based cancer screening algorithms to improve cancer test sensitivity by more than 2x for men and 3.5x for women over biomarkers alone (based on affiliate research funded by 20/20, see data room for full article and additional disclosures)

Fundraise Highlights

  • Total Amount Raised: US $3,585,609
  • Total Investors: 1648
  • Total Round Size: US $14,700,000
  • Raise Description:  Series C
  • Minimum Investment:  US $502 per investor
  • Security Type:  Preferred Equity
  • Pre-Money valuation :  US $38,500,000

20/20 is a diagnostics company deploying real-world data based machine learning algorithms to improve the accuracy and usefulness of blood tests. Our primary areas of focus are cancer detection and COVID-19 Testing.


OneTest™: A New AI Powered Multi-Cancer Blood Test & Machine Learning Algorithm for Broad Spectrum Early Cancer Detection

In 2019, we began to actively market in the U.S. and overseas an AI powered blood test for the early detection of multiple cancers called OneTest™. We saw substantial Quarterly revenue growth in the U.S.

As reported in a recent study by Cancers, a leading global peer-reviewed journal, this product is believed to be the world’s first cancer screening blood test powered by a machine learning algorithm built from data from tens of thousands of individuals screened yearly in a real-world clinical setting.

East-to-West Model

Blood testing to screen for many different cancers, though not yet widespread in the U.S., is very common throughout East Asia. Everyday millions of individuals in Japan, Korea, and China, and elsewhere in Asia visit “Health Check Centers” where they are tested with many of the same biomarkers that are part of OneTest. The foundation of our product is based on this East Asian testing paradigm, but our proprietary algorithms substantially improve the accuracy of standard biomarker testing by reducing the number of missed cancers by more than half.

CoronaCheck™: A Blood test for COVID-19 Antibodies

20/20 is offering FDA Authorized antibody lab test developed by Roche Diagnostics, and importing and distributing a rapid blood test for COVID-19 antibodies. During the one-month period since beginning promotion on March 18, we have sold over 70,000 tests generating over $1.2 million in revenue. We are now committed to integrating a digital reader with the lateral flow strip to enhance diagnostic accuracy and acquiring data to build a machine-learning algorithm to improve the usefulness of these test to determine who may relax social distancing with minimal risk.  

Pitch Deck

Media Mentions

The Team

Founders and Officers

Jonathan Cohen

Founder & CEO

Jonathan Cohen is the founder, president, and CEO of 20/20 GeneSystems. Under Mr. Cohen’s leadership, 20/20 has brought in approximately $7.5 million in grant funding and launched two successful products, a bio-detection kit for suspicious powders used by hundreds of emergency responder organizations worldwide and a blood test for the early detection of lung cancer. He is the co-inventor of an A.I approach for improving tumor biomarker accuracy that is covered in a pending PCT International Patent Application.  Jonathan holds several degrees including a MS in biotechnology from Johns Hopkins university as well as a Law degree from American university.

Jonathan Cohen

Founder & CEO

Jonathan Cohen is the founder, president, and CEO of 20/20 GeneSystems. Under Mr. Cohen’s leadership, 20/20 has brought in approximately $7.5 million in grant funding and launched two successful products, a bio-detection kit for suspicious powders used by hundreds of emergency responder organizations worldwide and a blood test for the early detection of lung cancer. He is the co-inventor of an A.I approach for improving tumor biomarker accuracy that is covered in a pending PCT International Patent Application.  Jonathan holds several degrees including a MS in biotechnology from Johns Hopkins university as well as a Law degree from American university.

John Compton, PhD

Chairman, Board of Directors

Dr. Compton, a 20/20 shareholder, serves as Scientific Director and Co-President of GeneDx Inc., the operating assets of which were acquired by BioReference Laboratories (now part of Opko) in September 2006. GeneDx is a world leader in Genomics with an acknowledged expertise in rare and ultra rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx provides testing to patients and their families in more than 55 countries.  He has 25 years experience in the development and application of molecular biological techniques to answer questions about genetics and epidermal differentiation, and has authored more than 60 publications in the field. He holds B.S. degrees in Physics and Biology from MIT, received his Ph.D. from the University of California, Berkeley in Biophysics, and did his post-doctoral training in protein-DNA interactions at the Baylor College of Medicine. In 2003 they were jointly awarded the Entrepreneur of the Year award by the Technology Council of Maryland.

John Compton, PhD

Chairman, Board of Directors

Dr. Compton, a 20/20 shareholder, serves as Scientific Director and Co-President of GeneDx Inc., the operating assets of which were acquired by BioReference Laboratories (now part of Opko) in September 2006. GeneDx is a world leader in Genomics with an acknowledged expertise in rare and ultra rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx provides testing to patients and their families in more than 55 countries.  He has 25 years experience in the development and application of molecular biological techniques to answer questions about genetics and epidermal differentiation, and has authored more than 60 publications in the field. He holds B.S. degrees in Physics and Biology from MIT, received his Ph.D. from the University of California, Berkeley in Biophysics, and did his post-doctoral training in protein-DNA interactions at the Baylor College of Medicine. In 2003 they were jointly awarded the Entrepreneur of the Year award by the Technology Council of Maryland.

Jiming Zhou, PhD

VP OF EAST ASIA

Dr. Zhou graduated from Sichuan University (China) and served as an Associate Professor before moving to the US, conducting academic research at University of Iowa, focusing on lung cancer and other disorders. Dr. Zhou then joined industrial R&D, led a joint pharmaceutical project total milestones of $330 millions. From 2009, Dr. Zhou directed 2 independent clinical labs and co-funded 2 companies, worked with many large US and Chinese public and private healthcare institutes in multiple projects. Dr. Zhou published 20+ peer-reviewed manuscripts and owns several patents.

Jiming Zhou, PhD

VP OF EAST ASIA

Dr. Zhou graduated from Sichuan University (China) and served as an Associate Professor before moving to the US, conducting academic research at University of Iowa, focusing on lung cancer and other disorders. Dr. Zhou then joined industrial R&D, led a joint pharmaceutical project total milestones of $330 millions. From 2009, Dr. Zhou directed 2 independent clinical labs and co-funded 2 companies, worked with many large US and Chinese public and private healthcare institutes in multiple projects. Dr. Zhou published 20+ peer-reviewed manuscripts and owns several patents.

David Schodin, PhD

CHIEF INNOVATION OFFICER

Dr. Schodin is a PhD scientist with 10 years of experience in academic biochemical research and is an experienced lawyer, having worked at a private law firm and the Abbott Laboratories legal division. He started off at Abbott as Senior Patent Counsel as a client-facing patent attorney for the Abbott Pharmaceuticals Oncology and Pain therapeutic teams. He became the Director of Business Development and Licensing at Abbott Molecular where he was the lead negotiator and drafter.

David Schodin, PhD

CHIEF INNOVATION OFFICER

Dr. Schodin is a PhD scientist with 10 years of experience in academic biochemical research and is an experienced lawyer, having worked at a private law firm and the Abbott Laboratories legal division. He started off at Abbott as Senior Patent Counsel as a client-facing patent attorney for the Abbott Pharmaceuticals Oncology and Pain therapeutic teams. He became the Director of Business Development and Licensing at Abbott Molecular where he was the lead negotiator and drafter.

Michael Lebowitz, Ph.D.

Cheif Scientific Officer

Dr. Lebowitz has more than 18 years of experience in biomedical research within the biotech industry having previously served as Vice President of Research at Ariadne Diagnostics, LLC. He has been directly involved in the commercial launch of six cancer diagnostic tests and the research leading up to a pharmaceutical IND approval. Dr. Lebowitz holds a Ph.D. from the Johns Hopkins University School of Medicine in Biochemistry, Cellular, and Molecular Biology where he subsequently completed a three-year fellowship in immunology in the Department of Pathology, Division of Immunopathology.

Michael Lebowitz, Ph.D.

Cheif Scientific Officer

Dr. Lebowitz has more than 18 years of experience in biomedical research within the biotech industry having previously served as Vice President of Research at Ariadne Diagnostics, LLC. He has been directly involved in the commercial launch of six cancer diagnostic tests and the research leading up to a pharmaceutical IND approval. Dr. Lebowitz holds a Ph.D. from the Johns Hopkins University School of Medicine in Biochemistry, Cellular, and Molecular Biology where he subsequently completed a three-year fellowship in immunology in the Department of Pathology, Division of Immunopathology.

Michael Ross, MD

Board member

Dr. Ross is the Chairman and CEO of Euclid Systems Corporation (Herndon, VA) where he led the growth of this ophthalmic medical device company from $3.1 million to over $8.1 million in revenue. The bulk of Euclid’s sales are in China and East Asia where Michael visits 4-5 times per year. Prior to joining Euclid, he was CEO of E-P Therapeutics, and was a Medical and Scientific Advisor to StemCyte, Inc. Michael was elected to the board of the Generic Pharmaceuticals Association after only two years in the industry. Board certified in Obstetrics and Gynecology, he was a founding member of a OB-GYN-Infertility practice in Northern Virginia.

Michael Ross, MD

Board member

Dr. Ross is the Chairman and CEO of Euclid Systems Corporation (Herndon, VA) where he led the growth of this ophthalmic medical device company from $3.1 million to over $8.1 million in revenue. The bulk of Euclid’s sales are in China and East Asia where Michael visits 4-5 times per year. Prior to joining Euclid, he was CEO of E-P Therapeutics, and was a Medical and Scientific Advisor to StemCyte, Inc. Michael was elected to the board of the Generic Pharmaceuticals Association after only two years in the industry. Board certified in Obstetrics and Gynecology, he was a founding member of a OB-GYN-Infertility practice in Northern Virginia.

Notable Advisors & Investors

Ping An Ventures

Investor, Strategic Investor

Jeffrey Allard, PhD

Advisor, ADVISOR

Term Sheet

Fundraising Description

  • Round type:
    Series C

  • Round size:
    US $14,700,000

  • Raised to date:
    US $3,585,609

  • Minimum investment:
    US $502
  • Key Terms

  • Security Type:
    Preferred Equity

  • Share price:
    US $4.4

  • Pre-Money valuation:
    US $38,500,000

  • Is participating?:
    Yes

  • Liquidation preference:
    1.0x
  • Additional Terms

  • Custody of Shares

    Investors who invest $50,000 or less will have their securities held in trust with a Custodian that will serve as a single shareholder of record. These investors will be subject to the Custodian’s Account Agreement, including the electronic delivery of all required information. 


  • Use of Proceeds

    Investor Perks

    Those who invest by Friday, July 31st, 2020 at 11:59pm ET will receive an upgrade to the next level of perks.

    • $1,500-$4,999  One free OneTest for Cancer and COVID-19 antibody test
    • $5,000-$9,999-   Three free OneTests for Cancer and COVID-19 antibody tests
    • $10,000+ (choice of either):

    1. Free COVID-19 antibody tests for up to 20 employees of your business
    2. Free yearly OneTest for Cancer test for the lifetime of the investor

    *COVID-19 related perks are dependent on product availability and regulatory requirements.

    It is advised that you consult a tax professional to fully understand any potential tax implications of receiving investor perks before making an investment.

    Prior Rounds

    This chart does not represent guarantees of future valuation growth and/or declines.

    Series B

  • Round Size
    US $5,195,032
  • Closed Date
    Feb 14, 2019
  • Security Type
    Preferred Equity
  • Pre-Money valuation
    US $26,000,000
  • Series A

  • Round Size
    US $5,570,000
  • Closed Date
    Dec 29, 2017
  • Security Type
    Preferred Equity
  • Pre-Money valuation
    US $20,000,000
  • Market Landscape

    Background

    20/20 is a digital diagnostics company that commercializes blood tests for diseases such as cancer that are powered by its innovative & proprietary machine learning algorithms to improve diagnostic accuracy.

    Innovation

    We believe 20/20 is among the first companies to commercialize multi-cancer screening blood tests powered by AI and machine learning algorithms built with real-world outcome data from tens of thousands of previously tested individuals.  We are actively building patent and other barriers to entry for emerging competitors.

    For COVID-19 antibody tests we are using a similar model to collect data to build algorithms to improve predictive values.  

    Addressing Prevalent Issues

    Recent studies by leading cancer geneticists at Johns Hopkins suggest that far more cancers are caused by aging than from family history, the environment, or lifestyle. This suggests that all adults, beginning in middle age, should be screened regularly for a wide array of cancers. Additionally, according to the National Cancer Institute, approximately 38.4% of men and women will be diagnosed with cancer at some point during their lifetimes

    A Global Market

    Thus the market for multi-cancer screening blood tests includes all adults worldwide roughly between the ages of 45 and 75 (the optimum ages for cancer screening). We believe there are no widely used safe and affordable tests that help identify as many cancers as OneTest at comparable price and accuracy levels.

    Competitive Advantage

    20/20 is among the first companies to collect real-world outcome data from tens of thousands of individuals screened for cancer using tumor markers and using this data to build machine learning algorithms that improve results.   Importantly this data is "pre-diagnostic" (i.e. collected before cancer diagnosis) which is the gold standard for testing healthy individuals.  

    Risks and Disclosures

    We are an early revenue stage company and have incurred operating losses since inception and we do not know when we will attain profitability. An investment in our securities is highly risky and could result in a complete loss of your investment if we are unsuccessful in our business plans.

    We are an early stage company. Since inception, we have incurred operating losses and negative cash flow, and we expect to continue to incur losses and negative cash flow in the future. Our net losses for the years ended December 31, 2019 and 2018 were approximately $2.4 million and $1.5 million, respectively. Since inception, we have financed our operations through the sale of our securities, product revenues and government research grants and contracts. There is no assurance that we will be able to obtain adequate financing that we may need, or that any such financing that may become available will be on terms that are favorable to us and our stockholders. Ultimately, our ability to generate sufficient operating revenue to earn a profit depends upon our success in developing and marketing or licensing our diagnostic tests and technology. Any failure to do so could result in the possible closure of our business or force us to seek additional capital through loans or additional sales of our equity securities to continue business operations, which could dilute the value of any securities you hold, or could result in the loss of your entire investment.

    In order to invest, you will be required to irrevocably subscribe to the offering via the online platform and agree to the terms of the offering, the subscription agreement, and any other relevant exhibit attached thereto. Pursuant to the terms of the subscription agreement, you are agreeing that: (i) you understand that our company is subject to all the risks that apply to early stage companies, whether or not those risks are explicitly set out in this offering circular, (ii) you have had such opportunity as you deem necessary (which opportunity may have been presented through online chat or commentary functions) to discuss our business, management and financial affairs with senior management of our company and have had the opportunity to review our operations and facilities, and (iii) you have had the opportunity to ask questions of and receive answers from our management regarding the terms and conditions of this investment.

    We will need to attract additional capital to scale our business but have no assurance that we can do so successfully.

    We will be incurring significant sales and marketing costs as we commercialize our diagnostic test products. We will need to raise additional capital to pay operating expenses until we are able to generate sufficient revenues from diagnostic test sales, royalties, and license fees, and we will need to sell additional equity or debt securities to meet those capital needs. Our ability to raise additional equity or debt capital will depend not only on progress made marketing and selling our diagnostic tests, but also will depend on access to capital and conditions in the capital markets. There is no assurance that we will be able to raise capital at times and in amounts needed to finance the development and commercialization of our diagnostic tests, maintenance of our CLIA certified diagnostic laboratory, and general operations. Even if capital is available, it may not be available on terms that we or our stockholders would consider favorable. Furthermore, sales of additional equity securities could result in the dilution of the interests of our stockholders.

    Our success depends heavily on our cancer screening tests.

    For the foreseeable future, our ability to generate revenues will depend almost entirely on the commercial success of our cancer tests. The commercial success and our ability to generate revenues will depend on a variety of factors, including the following:

    • patient acceptance of and demand for our tests;
    • acceptance in the medical community;
    • successful sales, marketing, and educational programs, including successful direct-to-patient marketing such as online advertising;
    • the amount and nature of competition from other multi- cancer screening products and procedures;
    • the ease of use of our ordering process for physicians; and
    • maintaining and defending patent protection for the intellectual property and our ability to establish and maintain adequate commercial manufacturing, distribution, sales and CLIA laboratory testing capabilities.

    If we are unable to develop and maintain substantial sales of our tests or if we are significantly delayed or limited in doing so, our business prospects, financial condition and results of operation would be adversely affected.

    The success of our tests depends on the degree of market acceptance by physicians, patients, and others in the medical community.

    Our tests may not gain market acceptance by physicians, and others in the medical community. The degree of market acceptance of our tests will depend on a number of factors, including:

    • its demonstrated sensitivity and specificity for detecting cancers;
    • its price;
    • the availability and attractiveness of alternative screening methods;
    • the willingness of physicians to prescribe our tests; and
    • the ease of use of our ordering process for physicians.

    If our OneTest does not achieve an adequate level of acceptance, we may not generate the substantial revenues we need to generate to become profitable.

    Our near-term revenues will be derived mainly from payment from consumers and employers rather than government or private health insurance.

    Should we be able to successfully market our diagnostic tests and software we will, for at least the near-term, rely on self-pay from the consumers and employers but may not be able to receive reimbursement for them from payers, such as health insurance companies, health maintenance organizations and Medicare, or any reimbursement that we receive may be lower than we anticipate. We cannot guarantee that a sufficient number of consumers or their employers will willingly pay the amounts we require to sustain growth and profitability.

    Our inability to manage growth could harm our business.

    We have added, and expect to continue to add, additional personnel in the areas of sales and marketing, laboratory operations, billing and collections, quality assurance and compliance. As we build our commercialization efforts and expand research and development activities, the scope and complexity of our operations is increasing significantly. As a result of our growth, our operating expenses and capital requirements have also increased, and we expect that they will continue to increase, significantly. Our ability to manage our growth effectively requires us to forecast expenses accurately, and to properly forecast and expand operational and testing facilities, if necessary, to expend funds to improve our operational, financial and management controls, reporting systems and procedures. As we move forward in commercializing our tests, we will also need to effectively manage our growing manufacturing, laboratory operations and sales and marketing needs. If we are unable to manage our anticipated growth effectively, our business could be harmed.

    The success of our business is substantially dependent upon the efforts of our senior management team.

    Our success depends largely on the skills, experience and performance of key members of our senior management team who are critical to directing and managing our growth and development in the future. Our success is substantially dependent upon our senior management’s ability to lead our company, implement successful corporate strategies and initiatives, develop key relationships, including relationships with collaborators and business partners, and successfully commercialize products and services. While our management team has significant experience development of diagnostic products, we have considerably less experience in commercializing these products or services. The efforts of our management team will be critical to us as we develop our technologies and seek to commercialize our tests and other products and services.

    Our success depends on our ability to retain our managerial personnel and to attract additional personnel.

    Our success depends in large part on our ability to attract and retain managerial personnel. If we were to lose any of our senior management team, we may experience difficulties in competing effectively, developing our technologies and implementing our business strategies. Competition for desirable personnel is intense, and there can be no assurance that we will be able to attract and retain the necessary staff. The failure to maintain management or to attract sales personnel could materially adversely affect our business, financial condition and results of operations.

    We currently manufacture our tests predominantly in one facility and perform our testing in one laboratory facility. As demand for our tests grow, we may lack adequate facility space and capabilities to meet increased processing requirements. Moreover, if these or any future facilities or our equipment were damaged or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operate our business could be materially harmed.

    We currently perform testing in a single laboratory facility in Rockville, Maryland. Our headquarters and manufacturing facilities are also located in Rockville, Maryland.

    As we expand sales and increase the number of tests processed by our laboratory facility, we may need to expand or modify our existing laboratory facility or acquire new laboratory facilities to increase our processing capacity. Any failure to do so on terms acceptable to us, if at all, may significantly delay our processing times and capabilities, which may adversely affect our business, financial condition and results of operation.

    If these, or any future facilities, were to be damaged, destroyed or otherwise unable to operate, whether due to fire, floods, storms, tornadoes, other inclement weather events or natural disasters, employee malfeasance, terrorist acts, power outages, or otherwise, our business could be severely disrupted. If our laboratory is disrupted, we may not be able to perform testing or generate test reports as promptly as patients and healthcare providers require or expect, or possibly not at all. If we are unable to perform testing or generate test reports within a timeframe that meets patient and healthcare provider expectations, our business, financial results and reputation could be materially harmed.

    We currently maintain insurance against damage to our property and equipment and against business interruption and research and development restoration expenses, subject to deductibles and other limitations. If we have underestimated our insurance needs with respect to an interruption, or if an interruption is not subject to coverage under our insurance policies, we may not be able to cover our losses.

    Failure of our internal controls over financial reporting could harm our business and financial results.

    Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting for external purposes in accordance with accounting principles generally accepted in the U.S. Internal control over financial reporting includes maintaining records that in reasonable detail accurately and fairly reflect our transactions; providing reasonable assurance that transactions are recorded as necessary for preparation of our financial statements; providing reasonable assurance that receipts and expenditures of our assets are made in accordance with management authorization; and providing reasonable assurance that unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements would be prevented or detected on a timely basis. Because of its inherent limitations, internal control over financial reporting is not intended to provide absolute assurance that a misstatement of our financial statements would be prevented or detected. Our growth and entry into new diagnostic tests, technologies and markets will place significant additional pressure on our system of internal control over financial reporting. Any failure to maintain an effective system of internal control over financial reporting could limit our ability to report our financial results accurately and timely or to detect and prevent fraud.

    We will spend a substantial amount of our capital on data acquisition, data analytics and algorithm development, but our products might not succeed in gaining widespread market acceptance.

    We have developed and will continually refine new biomarker test panels and associated algorithms. The main focus of these products is on early detection of cancer. Our technologies many not prove to be sufficiently efficacious or medically useful to gain widespread adoption or market share. The diagnostics tests and software that we have introduced to the market to date and have not yet generated significant revenues. Without diagnostic test sales or licensing fee revenues, we will not be able to operate at a profit, and we will not be able to cover our operating expenses without raising additional capital.

    Physicians and hospitals may be reluctant to try a new diagnostic test due to the high degree of risk associated with the application of new technologies and diagnostic tests in the field of human medicine, especially if the new test differs from the current standard of care for detecting cancer in patients. Competing tests for the screening or initial diagnosis of cancer are being developed by established companies, other small biotechnology companies, and academic laboratories.

    There also is a risk that our competitors may succeed in developing more accurate or more cost effective diagnostic tests that could render our diagnostic tests and technologies obsolete or noncompetitive. Even if our tests are technically superior, we may not be able to differentiate our products sufficiently from our competition.

    Our business is subject to various complex laws and regulations. We could be subject to significant fines and penalties if we or our partners fail to comply with these laws and regulations. 

    As a provider of clinical diagnostic products and services, we and our partners are subject to extensive and frequently changing federal, state and local laws and regulations governing various aspects of our business. In particular, the clinical laboratory industry is subject to significant governmental certification and licensing regulations, as well as federal and state laws regarding:

    • test ordering and billing practices;
    • marketing, sales and pricing practices;
    • health information privacy and security, including the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and comparable state laws;
    • anti-markup legislation; and
    • consumer protection.

    We are also required to comply with FDA regulations, including with respect to our labeling and promotion activities. In addition, advertising of our tests is subject to regulation by the Federal Trade Commission, or FTC. Violation of any FDA requirement could result in enforcement actions, such as seizures, injunctions, civil penalties and criminal prosecutions, and violation of any FTC requirement could result in injunctions and other associated remedies, all of which could have a material adverse effect on our business. Most states also have similar regulatory and enforcement authority for devices. Additionally, most foreign countries have authorities comparable to the FDA and processes for obtaining marketing approvals. Obtaining and maintaining these approvals, and complying with all laws and regulations, may subject us to similar risks and delays as those we could experience under FDA and FTC regulation. We incur various costs in complying and overseeing compliance with these laws and regulations.

    Healthcare policy has been a subject of extensive discussion in the executive and legislative branches of the federal and many state governments and healthcare laws and regulations are subject to change. Development of the existing commercialization strategy for our tests have been based on existing healthcare policies. We cannot predict what additional changes, if any, will be proposed or adopted or the effect that such proposals or adoption may have on our business, financial condition and results of operations. 

    If we or our partners, including independent sales representatives, fail to comply with these laws and regulations, we could incur significant fines and penalties and our reputation and prospects could suffer. Additionally, our partners could be forced to cease offering our products and services in certain jurisdictions, which could materially disrupt our business.

    If we are unable to obtain and enforce patents and to protect our trade secrets, others could use our technology to compete with us, which could create undue competition and pricing pressures. There is no certainty that our pending or future patent applications will result in the issuance of patents or that our issued patents will be deemed enforceable.

    The success of our business depends significantly on our ability to operate without infringing patents and other proprietary rights of others. If the technology that we use infringes a patent held by others, we could be sued for monetary damages by the patent holder or its licensee, or we could be prevented from continuing research, development, and commercialization of diagnostic tests that rely on that technology, unless we are able to obtain a license to use the patent. The cost and availability of a license to a patent cannot be predicted, and the likelihood of obtaining a license at an acceptable cost would be lower if the patent holder or any of its licensees is using the patent to develop or market a diagnostic test with which our diagnostic test would compete. If we could not obtain a necessary license, we would need to develop or obtain rights to alternative technologies, which could prove costly and could cause delays in diagnostic test development, or we could be forced to discontinue the development or marketing of any diagnostic tests that were developed using the technology covered by the patent.

    We have issued patents and patent applications pending worldwide that are owned by or exclusively licensed to us. We and our collaborators expect to continue to file and prosecute patent applications covering the products and technology that we commercialize. However, there is no assurance that any of our licensed patent applications, or any patent applications that we have filed or that we may file in the future in the United States or abroad, will result in the issuance of patents.

    Our success will depend in part on our ability to obtain and enforce patents and maintain trade secrets in the United States and in other countries. If we are unsuccessful in obtaining and enforcing patents, our competitors could use our technology and create diagnostic tests that compete with our diagnostic tests, without paying license fees or royalties to us.

    The relatively recent Supreme Court decisions in Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Alice Corp. v. CLS Bank Int’l may adversely impact our ability to obtain strong patent protection for some or all of our diagnostic tests and associated algorithms.

    International operations could subject us to risks and expenses that could adversely impact the business and results of operations.

    To date, we have not undertaken substantial commercial activities outside the United States. We have evaluated commercialization in Asian countries. If we seek to expand internationally, or launch other products or services internationally, in the future, those efforts would expose us to risks from the failure to comply with foreign laws and regulations that differ from those under which we operate in the U.S., as well as U.S. rules and regulations that govern foreign activities such as the U.S. Foreign Corrupt Practices Act. In addition, we could be adversely affected by other risks associated with operating in foreign countries. Economic uncertainty in some of the geographic regions in which we might operate, including developing regions, could result in the disruption of commerce and negatively impact cash flows from our operations in those areas.

    These and other factors may have a material adverse effect on any international operations we may seek to undertake and, consequently, on our financial condition and results of operations.

    The company has engaged in related party transactions. 

    The Company has historically employed or contracted with immediate family members of the Chief Executive Officer. Such arrangements are under compensation arrangements for services provided in the normal course of business. As of December 31, 2019 and 2018, the Company has an outstanding balance due to Barry Cohen, the Chief Executive Officer’s brother, in the amount of $0 and $27,832 for professional services, respectively.

    From time-to-time, investors in the Company are directed to deposit funds in a Limited Liability Company (“Investment LLC”) set up by the Company for the purposes of managing investments seeking the advantages of the Maryland Biotechnology Investor Tax Credit program. Funds from those Investment LLCs either have been or will be transferred to the Company pursuant to the rules and procedures of the tax credit program. Shares of the Company will be issued to investors in those Investment LLCs in the same manner as if they invested directly in the Company. While the Company performs the administrative tasks for the Investment LLC when they are active, the Company has no ownership, requirement to fund, or voting privileges within these entities.

    As of December 31, 2019 and 2018, the Company has approximately $2,700 and $57,000 due from various Investment LLCs controlled by certain stockholders of the Company as a result of funds advanced to them by the Company as it relates to the expected tax refunds under the Maryland Biotechnology Investor Tax Credit program. 

    During 2017, an Investment LLC received approximately $240,000 in funds for investment in the Company, pending application of the Maryland Biotechnology Investor Tax Credit. In November and December 2017, the Investment LLC lent the Company $210,000 which the Company subsequently repaid in 2018 upon the investment LLC receiving the requisite initial tax credit certificate. Furthermore, the $240,000 investment was made by the Investment LLC as part of a total investment of $309,000 for shares of Series A-2 Preferred Stock in 2018.

    We have relied and expect to continue to rely on third parties to conduct studies of the COVID-19 Rapid Antibody Test Kit that will be required by the FDA or other regulatory authorities and those third parties may not perform satisfactorily.

    Although we intend to sell the COVID-19 Rapid Antibody Test Kit by virtue of recent FDA guidance allowing for reduced product clinical and analytical studies, we have relied on third parties, such as independent testing laboratories and hospitals, to conduct such studies. Our reliance on these third parties will reduce our control over these activities. These third-party contractors may not complete activities on schedule or conduct studies in accordance with regulatory requirements or our study design. We cannot control whether they devote sufficient time, skill and resources to our studies. Our reliance on third parties that we do not control will not relieve us of any applicable requirement to prepare, and ensure compliance with, various procedures required under good clinical practices. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if the third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our studies may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for additional diagnostic tests.

    *Please refer to Offering Circular for full list of Risk Factors

    General Risks and Disclosures

    Start-up investing is risky. Investing in startups is very risky, highly speculative, and should not be made by anyone who cannot afford to lose their entire investment. Unlike an investment in a mature business where there is a track record of revenue and income, the success of a startup or early-stage venture often relies on the development of a new product or service that may or may not find a market. Before investing, you should carefully consider the specific risks and disclosures related to both this offering type and the company which can be found in this company profile and the documents in the data room below.

    Your shares are not easily transferable. You should not plan on being able to readily transfer and/or resell your security. Currently there is no market or liquidity for these shares and the company does not have any plans to list these shares on an exchange or other secondary market. At some point the company may choose to do so, but until then you should plan to hold your investment for a significant period of time before a "liquidation event" occurs. A "liquidation event" is when the company either lists their shares on an exchange, is acquired, or goes bankrupt.

    The Company may not pay dividends for the foreseeable future. Unless otherwise specified in the offering documents and subject to state law, you are not entitled to receive any dividends on your interest in the Company. Accordingly, any potential investor who anticipates the need for current dividends or income from an investment should not purchase any of the securities offered on the Site.

    Valuation and capitalization. Unlike listed companies that are valued publicly through market-driven stock prices, the valuation of private companies, especially startups, is difficult to assess and you may risk overpaying for your investment. In addition, there may be additional classes of equity with rights that are superior to the class of equity being sold.

    You may only receive limited disclosure. While the company must disclose certain information, since the company is at an early-stage they may only be able to provide limited information about its business plan and operations because it does not have fully developed operations or a long history. The company may also only obligated to file information periodically regarding its business, including financial statements. A publicly listed company, in contrast, is required to file annual and quarterly reports and promptly disclose certain events — through continuing disclosure that you can use to evaluate the status of your investment.

    Investment in personnel. An early-stage investment is also an investment in the entrepreneur or management of the company. Being able to execute on the business plan is often an important factor in whether the business is viable and successful. You should be aware that a portion of your investment may fund the compensation of the company's employees, including its management. You should carefully review any disclosure regarding the company's use of proceeds.

    Possibility of fraud. In light of the relative ease with which early-stage companies can raise funds, it may be the case that certain opportunities turn out to be money-losing fraudulent schemes. As with other investments, there is no guarantee that investments will be immune from fraud.

    Lack of professional guidance. Many successful companies partially attribute their early success to the guidance of professional early-stage investors (e.g., angel investors and venture capital firms). These investors often negotiate for seats on the company's board of directors and play an important role through their resources, contacts and experience in assisting early-stage companies in executing on their business plans. An early-stage company may not have the benefit of such professional investors.

    Representatives of SI Securities, LLC are affiliated with SI Advisors, LLC ("SI Advisors") Representatives of SI Securities, LLC are affiliated with SI Advisors, LLC ("SI Advisors"). SI Advisors is an exempt investment advisor that acts as the General Partner of SI Selections Fund I, L.P. ("SI Selections Fund"). SI Selections Fund is an early stage venture capital fund owned by third-party investors. From time to time, SI Selections Fund may invest in offerings made available on the SeedInvest platform, including this offering. Investments made by SI Selections Fund may be counted towards the total funds raised necessary to reach the minimum funding target as disclosed in the applicable offering materials.

    20/20 GeneSystems, Inc's 20/20 GeneSystems Offering Circular

    The offering circular is the legal document filed with the SEC for a Regulation A offering and provides facts that an investor needs to make an informed investment decision. The offering circular includes an overview of company and company's business, historical financials and capitalization, and key risk factors.

    Download 20/20 GeneSystems, Inc's  20/20 GeneSystems Offering Circular here.

    Frequently Asked Questions

    About Reg A Offerings
    What does it mean that the SEC has qualified this offering?

    "The SEC has qualified this offering" means the SEC has permitted 20/20 GeneSystems, Inc to offer for sale the securities described in the Offering Circular to investors such as you. The SEC is not judging the merits, accuracy, or completeness of the offering and information in the Offering Circular.


    Making an Investment in 20/20 GeneSystems, Inc
    How does investing work?

    When you complete your investment on SeedInvest, your money will be transferred to an escrow account where an independent escrow agent will watch over your investment until it is accepted by 20/20 GeneSystems, Inc. Once 20/20 GeneSystems, Inc accepts your investment, and certain regulatory procedures are completed, your money will be transferred from the escrow account to 20/20 GeneSystems, Inc in exchange for your securities. At that point, you will be a proud owner in 20/20 GeneSystems, Inc.


    What is the difference between preferred equity and a convertible note?

    Preferred equity is usually issued to outside investors and carries rights and conditions that are different from that of common stock. For example, preferred equity may include rights that prevent or minimize the effects of dilution or grants special privileges in situations when the company is sold.

    A convertible note is a unique form of debt that converts into equity, usually in conjunction with a future financing round. The investor effectively loans money to a startup with the expectation that they will receive equity in the company in the future at a discounted price per share when the company raises its next round of financing.

    To learn more about startup investment types check out “How to Choose a Startup Investment” in our academy.


    What will I need to complete my investment?

    To make an investment, you will need the following information readily available:

    1. Personal information such as your current address and phone number
    2. Employment and employer information
    3. Net worth and income information
    4. Social Security Number or passport
    5. ABA bank routing number and checking account number (typically found on a personal check or bank statement)

    What if I change my mind about investing?

    Until a closing occurs, you may cancel your investment at any time, for any reason. You will receive an email when the closing occurs and your securities have been issued. If you have already funded your investment and your funds are in escrow, your funds will be promptly refunded to you upon cancellation. To cancel your investment, please go to your portfolio page by clicking your profile icon in the top right corner.


    After My Investment
    How can I sell my securities in the future?

    Currently there is no market or liquidity for these securities. Right now 20/20 GeneSystems, Inc does not plan to list these securities on a national exchange or another secondary market. At some point 20/20 GeneSystems, Inc may choose to do so, but until then you should plan to hold your investment for a significant period of time before a “liquidation event” occurs. A “liquidation event” is when 20/20 GeneSystems, Inc either lists their securities on an exchange, is acquired, or goes bankrupt.


    How do I keep track of this investment?

    You can return to SeedInvest at any time to view your portfolio of investments and obtain a summary statement.


    Other General Questions
    What is this page about?

    This is 20/20 GeneSystems, Inc's fundraising profile page, where you can find information that may be helpful for you to make an investment decision in their company. The information on this page includes the company overview, team bios, and the risks and disclosures related to this investment opportunity. You will also find a copy of the 20/20 GeneSystems, Inc's Offering Circular, which has been qualified by the SEC. The Offering Circular includes important details about 20/20 GeneSystems, Inc's fundraise that you should review before investing.


    What are the risks of this investment?

    This investment is highly speculative and should not be made by anyone who cannot afford to risk the entire investment amount. In addition to these risks, you should carefully consider the specific information and risks disclosed in 20/20 GeneSystems, Inc’s profile and Offering Circular.