S-1 1 forms-1.htm

 

As filed with the United States Securities and Exchange Commission on July 13, 2022.

 

Registration No. 333- 

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM S-1

 

REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

 

HESPEROS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware   8731   47-2107365
(State or Other Jurisdiction of
Incorporation or Organization)
  (Primary Standard Industrial
Classification Code Number)
  (I.R.S. Employer
Identification Number)

 

12501 Research Parkway Suite 100

Orlando, FL 32826

(407) 900-5915

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

 

James F. Kronauge, Jr., Ph.D.

Chief Executive Officer

12501 Research Parkway Suite 100

Orlando, FL 32826

(407) 900-5915

 

(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For Service)

 

Copies to:

 

Michael B. Kirwan

John Wolfel

Foley & Lardner LLP

One Independent Drive, Suite 1300

Jacksonville, Florida 32202

Phone: (904) 359-2000

Facsimile: (904) 359-8700

 

Leslie Marlow

Hank Gracin

Patrick J. Egan

Blank Rome LLP

1271 Avenue of the Americas

New York, New York 10020

Phone: (212) 885-5000

Facsimile: (212) 885-5001

 

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

 

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

 

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

 

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

 

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

 

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

 

 

Large accelerated filer ☐

 

Accelerated filer ☐

       
 

Non-accelerated filer ☒

 

Smaller reporting company ☒

       
     

Emerging growth company ☒

 

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

 

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 

 

 

   

 

 

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

 

PRELIMINARY PROSPECTUS

SUBJECT TO COMPLETION

DATED JULY 13, 2022

 

               Shares

Common Stock

 

 

Hesperos, Inc.

 

 

This is a firm commitment initial public offering of shares of common stock of Hesperos, Inc. We anticipate that the initial public offering price of our shares will be between $       and $       per share.

 

Prior to this offering, there has been no public market for our common stock. We have applied to list our shares of common stock on The Nasdaq Capital Market under the symbol “HESP.” Completion of this offering is contingent on the approval of our listing application for trading on the Nasdaq Capital Market. No assurance can be given that our application will be approved.

 

We are an “emerging growth company” and a “smaller reporting company,” each as defined under the federal securities laws and, as such, have elected to comply with certain reduced reporting requirements for this prospectus and may elect to do so in future filings. See the section titled “Implications of Being an Emerging Growth Company and a Smaller Reporting Company.”

 

Upon completion of this offering, we will be a “controlled company” as defined in the corporate governance rules of the Nasdaq Capital Market and, therefore, we will qualify for, and intend to rely on, exemptions from certain Nasdaq corporate governance requirements.

 

Investing in our common stock involves a high degree of risk. Please read “Risk Factors” beginning on page 12 of this prospectus for a discussion of factors you should consider before buying shares of our common stock.

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 

  Per Share    Total  
Public offering price  $              $           
Underwriting discounts and commissions(1)  $    $  
Proceeds, before expenses, to us  $    $  

 

(1) Underwriting discounts and commissions do not include a non-accountable expense allowance equal to 1.0% of the initial public offering price payable to the underwriters. We refer you to “Underwriting” beginning on page 82 for additional information regarding underwriters’ compensation.

 

We have granted a 30-day option to the representative of the underwriters to purchase up to           additional shares of common stock from us solely to cover over-allotments, if any, at the public offering price, less underwriting discounts and commissions.

 

The underwriters expect to deliver the shares to purchasers on or about          , 2022.

 

ThinkEquity

 

The date of this prospectus is             , 2022

 

 

 

 

 

 
 

 

 

 
 

 

TABLE OF CONTENTS

 

PROSPECTUS SUMMARY 1
SUMMARY SELECTED FINANCIAL DATA 10
RISK FACTORS 12
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 29
USE OF PROCEEDS 31
DIVIDEND POLICY 32
CAPITALIZATION 33
DILUTION 34
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 35
BUSINESS 45
MANAGEMENT 58
EXECUTIVE AND DIRECTOR COMPENSATION 65
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS 72
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 73
DESCRIPTION OF CAPITAL STOCK 74
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS 78
SHARES ELIGIBLE FOR FUTURE SALE 82
UNDERWRITING 84
LEGAL MATTERS 91
EXPERTS 91
WHERE YOU CAN FIND ADDITIONAL INFORMATION 91
INDEX TO FINANCIAL STATEMENTS F-1

 

We and the underwriters have not authorized anyone to provide you any information other than that contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we have referred you, and you should rely only on the information contained in this prospectus or in any such free writing prospectus. We and underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We and the underwriters are not making an offer to sell nor a solicitation of any offer to buy these securities in any jurisdiction where the offer or sale is not permitted. You should assume that the information appearing in this prospectus is accurate only as of the date on the front cover of this prospectus. Our business, financial condition, results of operations and prospects may have changed since that date.

 

For investors outside of the United States: we have not, and the underwriters have not, taken any action that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than the United States. Persons outside of the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of common stock and the distribution of this prospectus outside of the United States.

 

Our logo and some of our trademarks and tradenames are used in this prospectus, including our trademarks “Human-on-a-Chip” and “Human-on-a-Chip Company.” This prospectus also includes trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, trademarks, tradenames and service marks referred to in this prospectus may appear without the ®, TM and SM symbols, but those references are not intended to indicate in any way that we will not assert to the fullest extent under applicable law our rights or the rights of the applicable licensor to these trademarks, tradenames and service marks.

 

We obtained the statistical data, market data and other industry data and forecasts described in this prospectus from market research, publicly available information and industry publications. Industry publications generally state that they obtain their information from sources that they believe to be reliable, but they do not guarantee the accuracy and completeness of the information. Similarly, while we believe that the statistical data, industry data and forecasts and market research are reliable, we have not independently verified the data, and we do not make any representation as to the accuracy of the information. We have not sought the consent of the sources to refer to their reports appearing or incorporated by reference in this prospectus.

 

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PROSPECTUS SUMMARY

 

This summary only highlights the more detailed information appearing elsewhere in this prospectus. As this is a summary, it does not contain all of the information that you should consider in making an investment decision. You should read this entire prospectus carefully, including the information under “Risk Factors” and our financial statements and the related notes included elsewhere in this prospectus, before investing. As used in this prospectus, unless the context indicates or otherwise requires, the “Company,” “our Company,” “we,” “us,” and “our” refer to Hesperos, Inc.

 

Our Company

 

Hesperos, Inc., operating as a Contract Research Organization (“CRO”) has developed a disruptive technology that provides safety and efficacy testing of chemicals and novel therapeutics for the pharmaceutical, cosmetic, and food industries for drug discovery and development using its Human-on-a-Chip® multi-organ, microphysiological system. We are a socially-conscious company that uses our non-invasive, serum-free, multi-organ chip platform (Human-on-a-Chip) systems to provide pre-clinical analytical services with the goal of accelerating drug discovery and general toxicology testing and reducing use of animal testing. Our services primarily focus on systems composed of human cells representing select organs, which can be configured based on customer needs. Our technology and services provide research teams the opportunity to determine how the human body will respond when new drug compounds or drug combinations are introduced for both efficacy and toxicity in the same platform that interlinks organs or organ systems, including: heart, liver, lung, brain, skin, muscle, kidney, gastrointestinal (“GI”) tract, immune, neuromuscular and more. We also offer four basic validated Human-on-a-Chip systems for disease modeling and drug testing: Heart-Liver two-organ model, Neuromuscular (NMJ) junction two-organ model, Heart-Liver-Cancer three-organ model and Heart-Liver Skeletal Muscle Neuron four-organ model. Our platform can target rare diseases (of the over 7,000 known rare diseases, approximately 95 percent have no treatment because of a lack of animal models). We have licensed patents from Cornell University and the University of Central Florida to support our systems.

 

We have funded our operations primarily from grant funding from the National Institute of Health (NIH) and, to a lesser extent, from revenue generated from services provided to our pharmaceutical and cosmetic industry clients. As of March 31, 2021, we have received approximately $17.5 million in funding from Small Business Innovation Research (SBIR) grants from the NIH, with approximately an additional $7.4 million available for use through 2024, subject to availability of funds and satisfactory progress of each project as determined by the NIH. Dr. James Hickman, Chairman of our Board of Directors and one of our founders, has been our primary source of capital other than the grants from the NIH.

 

We had net loss of $0.5 million and net income of $0.1 million for the years ended December 31, 2021 and 2020, respectively, and total revenues of $5.2 million and $5.2 million for the years ended December 31, 2021 and 2020, respectively. We had net loss of $0.3 million and $0.1 million for the three months ended March 31, 2022 and 2021, respectively, and total revenue of $1.1 million and $1.2 million for the three months ended March 31, 2022 and 2021, respectively. The Company was incorporated in 2015 and has taken no significant outside investment to date.

 

Our Business

 

Our Human-on-a-Chip platform system mimics the process of initial patient evaluation during a clinical trial, where functional human in vitro tissues are evaluated similar to a patient undergoing medical testing to determine baseline performance metrics. Specific screens for heart rate, respiration, basic cognitive function, reflex tests on muscle and nerve, elimination, and chemical screens for liver, kidney and hematopoietic function can be integrated into our unique pumpless platform. If anything abnormal is observed, additional biomarkers are evaluated much like a blood test administered to a patient. If a chip ceases to function, a “post mortem” examination of the tissue is completed. This approach enables the platform to be utilized not only for acute but also chronic evaluation of drugs non-invasively for periods of up to several months depending on the system. Because of our holistic approach to the process of pre-clinical evaluation, more subtle effects, not just cell death, can be detected in our system. This use of functional readouts reduces the number and frequency of biomarker assays (a broad range of measures capturing cellular or organismal events at a given moment as objective medical signs used to measure the presence or progress of disease or the effects of treatment) which reduces costs and increases efficiency during pre-clinical evaluations.

 

 

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Our in vitro systems have been shown to rapidly and accurately assess individual human responses to pharmacological agents and cellular constructs. We have successfully completed projects with 15 commercial clients, including Roche Holdings AG (“Roche”), AstraZeneca plc (“AstraZeneca”), L’Oreal S.A. (“L’Oreal”), Sanofi and several others, the results of which are detailed in high impact journals. The Sanofi project, described in more detail below under “Recent Developments,” provided efficacy data for an investigational new drug (“IND”) application to the FDA which enabled the authorization of a clinical trial.

 

Ultimately, our device could be useful for personalized medicine. Creating platforms utilizing cells from patients representing various genetic and racial backgrounds would enable assessment of comparative responses within different patient subpopulations in future embodiments. We intend for our device to leverage future advancements in induced pluripotent stem cell (a type of pluripotent stem cell, which are cells that have the ability to self-renew by dividing and developing into all cell types, derived from adult somatic cells and reprogrammed through inducing genes and factors to be pluripotent, “iPSC”) production and directed differentiation to investigate patient specific drug/counter-measure responses, especially for rare diseases. A personalized medicine platform could advance cancer treatment by predicting an individual patient’s response before initiating therapy. In addition, patient-specific iPSC-derived cellular constructs could reveal personalized responses to viral or bacterial infection.

 

However, the creation of such platforms is dependent upon, among other things, our ability to obtain funding for such platforms and the continued development of our technology, which may be more expensive or take longer than we expect. If we are unable to obtain additional funding, we may be unsuccessful in such efforts.

 

Our Technology

 

Hesperos’ Human-on-a-Chip system is a multi-organ microphysiological system composed of interconnected chambers for each cell type or barrier tissue of interest. These human organ mimics use either primary (from patient donors) or iPSC-derived cells. Our Human-on-a-Chip systems currently may include up to six different organ types. Microelectrode arrays (MEA) and microcantilevers are used to monitor real time function, including force generation and electrical activity of cells representing the organ mimic over time as test compounds are dosed and circulated throughout the system. These non-invasive readouts of tissue function are direct indicators of cellular health, which reduce reliance on biomarkers that only rely upon cell death as the indication. Each organ model can be monitored for up to 28-days in a single system, as shown in our Advanced Functional Materials article that describes the project that we performed for L’Oreal (Oleaga et al., 2018:1805792 (2019)), with recirculating serum-free media allowing real time tracking of functional changes in response to treatments with minimal uncontrolled variables.

 

Hesperos’ customized services can utilize its phenotypic cellular assays (types of assays used in biological research and drug discovery to identify substances such as small molecules that alter the phenotype of a cell or an organism in a desired manner) to filter the vast number of hits and leads evaluated on a daily basis by pharmaceutical companies. Moreover, a customized platform can be developed to address a specific need of a customer.

 

Our Market

 

We believe that the current drug development process is inefficient, taking years from candidate compound identification to marketable drug, and incurring very high costs during the process. This inefficiency stems primarily from a significant failure rate of novel therapeutics during pre-clinical animal testing. Moreover, 9 of 10 drugs that appear safe and effective in animals fail in clinical human trials. As a functional, serum-free, interconnected human model, our Human-on-a-Chip system is a platform that provides insight into the efficacy and toxicity of novel therapeutics that was not previously possible using conventional methods and models.

 

Unlike existing animal models that have been shown to only predict success in the clinic in about 10% of cases, our human cell-based systems are designed to more accurately predict clinical outcomes by using human cells. In the case of rare diseases, our systems can provide models that do not exist or are not otherwise feasible due to the high cost of using animals in pre-clinical research. This field of technology can initially reduce and, after further development, could eliminate the need for animal models and could significantly decrease the cost of drug development.

 

The market for human-based safety and efficacy testing covers a number of fields, including: pharmaceutical development, food safety, general chemical testing, and cosmetics. We believe that each of these industries can be supported by our platforms. According to Global Industry Analysts, the global market for Absorption, Distribution, Metabolism, Excretion (ADME) Toxicology Testing was estimated at $6 billion in the year 2020. This market is projected to grow to $11.1 billion by 2026, growing at a compound annual growth rate (“CAGR”) of 10.9% over the analysis period. Currently, the Organ-on-a-Chip market is primarily a subset of ADME Toxicology Testing. The global Organ-on-a-Chip market was estimated to be $41 million in 2020 and is forecast to reach $581 million by 2028, growing at a CAGR of 39.1% according to a 2020 report by Valuates Reports, and outpacing the growth of other larger markets, including ADME Toxicology Testing.

 

While there are a number of companies offering services in the Organ-on-a-Chip market, we believe there are only two competitors with multi-organ interconnected cellular chip platforms where each organ chip is totally exposed to the fluidic streams, often referenced as 100% flow, currently in this commercial space.

 

To date, we have worked with 15 clients, 14 of which operate within the pharmaceutical industry and one of which operates within the cosmetic industry. We are currently working with 6 clients in the pharmaceutical industry to provide efficacy studies, toxicology studies, and model development.

 

 

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Our Competitive Advantages

 

There are a number of factors that differentiate Hesperos from competitors. The key advantages of Hesperos Human-on-a-Chip® system as compared to other microphysiological systems include:

 

Single Integrated System

 

Our system determines simultaneously efficacy and off-target toxicity for both single compound treatments and drug combinations in interconnected, multi-organ human based systems for both parent and metabolite(s) if a competent liver is present. Many of our competitors focus on single organ toxicity. To our knowledge, our device is the only multi-organ system on the market that maintains physiological relationships among components allowing research teams to determine the effectiveness of a drug compound (and its metabolites) while monitoring the effect on other organs in one system.

 

Flexibility

 

Our systems may include up to six different organ types, which can each be interchanged to investigate various physiologic, reactions, and types of diseases. Current organ models can include organ mimics for the cardiac system, liver, muscle, kidney and brain in addition to barrier tissues such as the blood-brain barrier, intestine and skin as well as recirculating immune cells.

 

Scalability

 

Our patented, pumpless system provides a low volume environment so metabolites can be generated at significant concentrations if a liver is present. By only requiring milligrams of candidate compounds (compared to kilograms required for animal models), our systems allow medicinal chemists to investigate several options prior to scaling development for animal testing or clinical applications. It also allows recirculating cells that normally would be damaged by pumped systems.

 

Superior Interaction among Components

 

Our systems recirculate serum-free media, which represents a blood surrogate circulation while maintaining cell viability and differentiation for up to 28-days while maintaining defined components. Serum-free media allow for better definition of mechanistic interactions among organs than serum-containing media.

 

 

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Proven Experience of our Founders

 

Our founders, Drs. Michael L. Shuler and James J. Hickman both have over 30 years of experience with microphysiological systems. Dr. Shuler is recognized in the industry as the founder of the body-on-a-chip field. Our platform has been validated in several peer-reviewed journals, such as an article published for Roche describing a recirculating system that has relevance to the infectious disease market in an innate immune system-on-a-chip platform (Sasserath et al. Adv. Sci. 7:2000323 (2020)).

 

Our Growth Strategy

 

Our goal is to pursue greater commercial adoption of our human-based preclinical models to facilitate the selection of drug candidates, especially at the medicinal chemistry stage, to determine which will be the most likely to succeed in expensive clinical trials. A modest increase in success in clinical trials will greatly reduce the cost of drug development, using current cost estimation procedures. We believe that our services will allow pharmaceutical companies to better determine which drug candidates will likely fail and which will likely succeed which in turn should lead to more life-saving or life-enhancing drugs at lower costs of discovery. We believe our services will be a significant resource to the rare disease community as there are over 7,000 rare diseases, of which approximately 95 percent have no treatment due to lack of animal models.

 

Our Human-on-a-Chip systems can provide guidance to pharmaceutical companies about which drugs should be taken into clinical trials and allow cosmetics companies to perform toxicology studies to augment and, we believe, eventually help eliminate the use of animal testing. Going forward, we believe our growth plans should allow us to generate substantial business from private and public life sciences companies.

 

As a platform technology, our services can be used to develop many drug discovery applications for both efficacy and safety evaluations. As a small company, we have limited resources to address the multitude of applications suitable for our platform technology and will initially focus on efficacy studies and analytic drug development services for the pharmaceutical industry, especially for rare diseases. Thus, our near term business strategy is to continue technology development of the Hesperos platform to decrease the cost of each evaluation, demonstrate its utility in specific services that the Company will offer, optimize the platform for reproducibility and scalability and develop other applications in collaboration with a limited number of long-term corporate partners.

 

We intend to use the proceeds from this offering to further enhance functionality and expand applications. We may expand the number of organ types and organ combinations in our systems, as well as increase the actual number of our systems in order to serve a greater number of customers, which is what we believe to be the primary factor limiting our revenue growth. Our systems are assembled manually and, during operation, they need to be removed from the constant temperature and atmospheric incubators for functional measurements. In addition, surface modifications of the organ chips and subsequent plating of cells on the modified surfaces is done manually. We intend to use the proceeds from this offering to enhance the repeatability and reliability of our system by improving the automation of the fabrication and measurement processes. In addition, we intend to build additional platforms and systems to allow us to further diversify the components for our platforms and to conduct additional projects based upon anticipated demand from our existing and new customers. However, our ability to develop and implement the automation of our fabrication and measurement processes which will enable increased efficacy and reliability may face implementation challenges that may not all be addressed with proceeds from this offering. Further, the continued development of our technology may be more expensive or take longer than we expect and we may not be successful in such efforts.

 

Recent Developments

 

On April 5, 2022, a peer-reviewed article titled “Classical Complement Pathway Inhibition in a ‘Human-on-a-Chip’ Model of Autoimmune Demyelinating Neuropathies” was published in Advanced Therapeutics. (Rumsey et al., Advanced Therapeutics 2022:2200030 (2022)). The project described in the article was one that we performed for Sanofi that provided efficacy data for support of their IND application for the rare diseases chronic inflammatory demyelinating polyneuropathy, which the FDA allowed to proceed to a Phase II clinical trial application (NCT04658472) in December 2020 and the clinical trial was authorized and began recruiting patients in April of 2021. Additional information relating to the studies may be found at https://www.nih.gov/news-events/news-releases/researchers-create-3-d-model-rare-neuromuscular-disorders-setting-stage-clinical-trial. However, there is no assurance that the FDA will give similar treatment to future studies that use our systems.

 

Corporate Information

 

Hesperos, Inc. was incorporated as a Delaware corporation in 2015. Our principal executive offices are located at 12501 Research Parkway, Suite 100, in Orlando, Florida and our phone number is (407) 900-5915. Our website can be found at www.hesperosinc.com. Our website and the information contained on our website or connected to our website are not and will not be deemed to be incorporated into this prospectus or the Registration Statement of which this prospectus forms a part, and you should not consider such information part of this prospectus or rely on any such information in making your decision whether to purchase our common stock.

 

Implications of Being an Emerging Growth Company and a Smaller Reporting Company

 

We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. As an “emerging growth company,” we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include, but are not limited to:

 

requiring only two years of audited financial statements in addition to any required unaudited interim financial statements with correspondingly reduced “Management’s discussion and analysis of financial condition and results of operations” in our filings with the Securities and Exchange Commission, or the SEC;
   
reduced disclosure about our executive compensation arrangements;
   
no non-binding advisory votes on executive compensation or golden parachute arrangements; and
   
exemption from compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to Section 404(b) of the Sarbanes Oxley Act of 2002, or SOX.

 

 

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We may take advantage of these exemptions for up to five years or such earlier time that we are no longer an “emerging growth company.” We will continue to remain an “emerging growth company” until the earliest of the following: (i) the last day of the fiscal year following the fifth anniversary of the date of the completion of this offering; (ii) the last day of the fiscal year in which our total annual gross revenue is equal to or more than $1.07 billion; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under SEC rules.

 

We are also a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act, and have elected to take advantage of certain of the scaled disclosures available to smaller reporting companies. To the extent that we continue to qualify as a “smaller reporting company” as such term is defined in Rule 12b-2 under the Exchange Act, after we cease to qualify as an emerging growth company, certain of the exemptions available to us as an “emerging growth company” may continue to be available to us as a “smaller reporting company,” including exemption from compliance with the auditor attestation requirements pursuant to SOX and reduced disclosure about our executive compensation arrangements. We will continue to be a “smaller reporting company” until we have $250 million or more in public float (based on our common stock) measured as of the last business day of our most recently completed second fiscal quarter or, in the event we have no public float or a public float that is less than $700 million, annual revenues of $100 million or more during the most recently completed fiscal year.

 

We may choose to take advantage of some, but not all, of these exemptions. We have taken advantage of reduced reporting requirements in this prospectus. Accordingly, the information contained herein may be different from the information you receive from other public companies in which you hold stock. In addition, the JOBS Act provides that an emerging growth company may take advantage of an extended transition period for complying with new or revised accounting standards, delaying the adoption of these accounting standards until they would apply to private companies. We have elected to avail ourselves of the extended transition period for complying with new or revised financial accounting standards. As a result of this accounting standards election, we will not be subject to the same implementation timing for new or revised accounting standards as other public companies that are not emerging growth companies which may make comparison of our financials to those of other public companies more difficult.

 

Controlled Company Exemption

 

Upon completion of this offering, we will be a “controlled company” as defined in the corporate governance rules of the Nasdaq Capital Market and, therefore, we will qualify for, and intend to rely on, exemptions from certain Nasdaq corporate governance requirements regarding the number of independent directors on our Board committees. See “Management—Controlled company exemption” for more information.

 

 

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Summary Risk Factors

 

Our business is subject to numerous risks and uncertainties that you should consider before investing in our common stock. You should carefully consider the risks described more fully in the section titled “Risk Factors” in this prospectus beginning on page 12, before making a decision to invest in our common stock. If any of these risks actually occurs, our business, financial condition and results of operations would likely be materially adversely affected. These risks, include, but are not limited to, the following:

 

Risks Related to the Development of our Human-on-a-Chip System

 

  Our success depends upon market acceptance of our platform, our ability to develop and commercialize new services and generate revenues and our ability to identify new markets for our technology;
     
  We have historically achieved limited profitability;
     
  Our Human-on-a-Chip systems represent new approaches that could result in heightened regulatory scrutiny, including for our customers’ regulatory submissions, or our inability to achieve regulatory acceptance or commercialization of our services;
     
  The development of new biopharmaceutical products and services that are used to support FDA regulatory approvals involves a lengthy and complex process and we may be unable to obtain regulatory acceptance for the platforms we are currently developing that require FDA approval;
     
  Our experience manufacturing our Human-on-a-Chip systems is limited. Manufacturing issues, including technical or quality issues, may arise that could cause delays in our development programs or increase costs. Furthermore, we may experience delays in regulatory approval of certain of our systems if we do not satisfy applicable manufacturing regulatory requirements;

 

  Approval by the FDA of INDs submitted by our customers will require acceptance of the data produced by our Human-on-a-Chip system used to support the IND. Even if the FDA does accept the data produced by our Human-on-a-Chip system, regulatory agencies in foreign jurisdictions may never accept such data as support for approval of clinical trials and we may never commercialize our system in such jurisdictions, which would limit our ability to realize their full market potential;
     
  We may expend our limited resources to pursue certain organ systems and fail to capitalize on organ systems that may be more profitable or for which there is a greater likelihood of success;
     
  The industry in which we operate is highly competitive and subject to rapid technological change. If our competitors are better able to develop and market products or services that are more effective, less costly, easier to use, or are otherwise more attractive, we may be unable to compete effectively with other companies;
     
  Our success will be dependent on acceptance of our platform and services by the pharmaceutical, biotechnology, and cosmetics communities;
     
  We rely on licenses from third parties to certain technology and intellectual property rights for some of our services and the licenses we currently have could terminate or expire;

 

Risks Related to Managing and Growing our Business

 

  Our business will be adversely impacted if we are unable to successfully attract, hire and integrate additional employees or contractors;
     
  We may require additional funding. Raising additional capital would cause dilution to our existing stockholders and may restrict our operations or require us to relinquish rights to our technologies or to our systems;
     
  We have been funded in part by government grant awards, which is not a guaranteed source of funding;
     
  Our business may be materially and adversely impacted by factors affecting the biopharmaceutical and healthcare industries;
     
  Global or regional health pandemics or epidemics, including COVID-19, could negatively impact our business operations, financial performance and results of operations;
     
  Any failure to protect our intellectual property rights could impair our ability to protect our proprietary technology and our brand;
     
  Global, market and economic conditions may negatively impact our business, financial condition and share price;

 

 

6

 

 

 

Risks Related to Protecting our Technology and Intellectual Property

     
  We may not be able to adequately defend against piracy of intellectual property in foreign jurisdictions;
     
  We may be sued by third parties for alleged infringement of their proprietary rights or misappropriation of intellectual property;

 

Risks Related to Governmental Regulations

 

  Government regulation of healthcare creates risks and challenges with respect to our compliance efforts and our business strategies;

 

Risks Related to Operating as a Public Company

 

  The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified board members;
     
  We are an emerging growth company, and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors;
     
  If we are unable to implement and maintain effective internal control over financial reporting in the future, our ability to produce accurate financial statements could be impaired, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock may decline;

 

Risks Related to Investing in Our Common Stock

 

  An active trading market may not develop for our securities, and you may not be able to sell your common stock at or above the offering price per share;
     
  Certain of our founding stockholders will continue to own a significant percentage of our common stock and will be able to exert significant control over matters subject to stockholder approval;
     
  As a “controlled company” under the rules of the Nasdaq Capital Market, we may choose to exempt our Company from certain corporate governance requirements that could have an adverse effect on our public stockholders;
     
  If you purchase our securities in this offering, you will incur immediate and substantial dilution in the book value of your investment;
     
  We might not be able to maintain the listing of our common stock on the Nasdaq Capital Market;
     
  The market price of our common stock may be volatile and may decline regardless of our operating performance, and you may lose all or part of your investments; and
     
  Provisions in our charter documents and under Delaware law could make an acquisition of our Company more difficult, limit attempts by our stockholders to replace or remove our current board of directors and limit the market price of our common stock.


 

 

7

 

 

 

The Offering

 

Common stock offered by us

                    shares (or                            shares if the underwriters exercise in full their option to purchase additional shares to cover over-allotments, if any).

   
Common stock to be outstanding after this offering*

                    shares (or                           shares if the underwriters exercise in full their option to purchase additional shares to cover over-allotments, if any).

   
Option to purchase additional shares

We have granted the underwriters a 30-day option to purchase up to                           additional shares of our common stock from us at the public offering price, less underwriting discounts and commissions.

   
Use of proceeds

We estimate that the net proceeds from this offering will be approximately $                           million, or approximately $                           million if the underwriters exercise their option to purchase additional shares to cover over-allotments, based on an assumed initial public offering price of $                  per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. We expect to use the proceeds from this offering to, among other things, enhance the fabrication of our Human-on-a-Chip systems; automate our system’s measurement processes; invest in research and lab staff; hire sales and marketing staff to target pharmaceutical and a broader set of commercial companies; and working capital and general corporate purposes. See “Use of Proceeds” for a more complete description of the intended use of proceeds from this offering.

   
Risk Factors

Investing in our common stock involves a high degree of risk and purchasers may lose their entire investment. You should read the “Risk Factors” section of this prospectus beginning on page 12 for a discussion of certain factors to consider carefully before deciding to purchase any shares of our common stock.

   
Proposed Nasdaq Capital Market Symbol

We have applied to list our common stock on the Nasdaq Capital Market under the symbol “HESP.” No assurance can be given that our shares of common stock will be approved for listing on Nasdaq.

   
Transfer Agent and Registrar

The transfer agent and registrar for our common stock is Equiniti Trust Company.

 

 

8

 

 

 

*The number of shares of our common stock to be outstanding after this offering is based on shares of common stock as of March 31, 2022 and excludes the following:

 

  281,250 shares of common stock granted to employees and directors as restricted stock awards vesting over five years;
     
  1,425,700 shares of common stock reserved for future issuance under our Omnibus Incentive Plan;
     
              shares of common stock issuable upon the exercise of the Representative’s Warrants;
     
 

            shares of common stock issuable upon the conversion of convertible notes; and

     
  Up to 30,000 shares of common stock issuable to the University of Central Florida Research Foundation pursuant to anti-dilution rights.

 

 

9

 

 

 

SUMMARY SELECTED FINANCIAL DATA

 

The following tables summarize our selected financial data for the periods and as of the dates indicated.

 

We have derived the following summary of financial data for the years ended December 31, 2021 and 2020 from our audited financial statements appearing elsewhere in this prospectus. We derived our summary financial data for the three months ended March 31, 2022 and 2021 from our unaudited condensed financial statements appearing elsewhere in this prospectus. The unaudited financial statements have been prepared on a basis consistent with our audited financial statements included in this prospectus and include, in our opinion, all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the financial information in those statements. Our historical results are not necessarily indicative of the results that may be expected in the future. Our balance sheet data is given:

 

  on an actual basis; and
     
  on an as adjusted basis to give effect to the issuance and sale of             shares of our common stock in this offering at the public offering price of             per share.

 

You should read the following summary of financial data in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Risk Factors,” and our financial statements and the related notes included elsewhere in this prospectus.

 

Statements of Operations Data

 

   Three Months Ended March 31, 2022     Three Months Ended March 31, 2021     Year Ended December 31, 2021   Year Ended December 31, 2020 
REVENUES                          
Grant revenue  $ 885,444     $ 988,684     $4,363,010   $4,754,641 
Commercial revenue    217,737       197,746      834,360    487,735 
                           
Total Revenues    1,103,181       1,186,430      5,197,370    5,242,376 
                           
Cost of Revenues    839,954       808,380      3,724,316    3,748,360 
                           
Gross Profit    263,227       378,050      1,473,054    1,494,016 
                           
Operating Expenses                          
General and administrative    588,448       406,723      1,848,928    1,576,718 
Total Operating Expenses    588,448       406,723      1,848,928    1,576,718 
                           
Loss from Operations    (325,221 )     (28,673 )    (375,874)   (82,702)
                           
Other Income (Expense)                          
Interest expense    (22,958 )     (31,621 )    (115,866)   (114,804)
Forgiveness of notes payable – PPP loan    -       -      -    244,800 
Other income    247       2,134      8,196    17,419 
Total Other Income (Expense), Net    (22,711 )     (29,487 )    (107,670)   147,415 
                           
Net (Loss) Income  $ (347,932 )   $ (58,160 )   $(483,544)  $64,713 
                           
Weighted average common shares outstanding:                          
Basic    9,125,699       8,948,035      9,011,393    8,933,016 
Diluted    9,125,699       8,948,035      9,011,393    9,422,316 
                           
Earnings (Loss) per common share, basic and diluted  $ (0.04 )   $ (0.01 )   $(0.05)  $0.01 

 

 

10

 

 

 

Balance Sheets Data

 

    March 31, 2022  
    Actual     As adjusted (1)  
             
ASSETS                
Cash and cash equivalents   $ 282,745          
Total Current Assets     877,155          
                 
Total Noncurrent Assets     3,250,600          
TOTAL ASSETS   $ 4,127,755          
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current Liabilities     1,737,474          
                 
Long-Term Liabilities     2,775,484          
TOTAL LIABILITIES     4,512,958          
                 
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT)     (385,203 )        
                 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)   $ 4,127,755          

 

(1) Gives further effect to the sale of            shares of common stock in this offering at an assumed initial public offering price of $          per share, which is the midpoint of the range set forth on the cover page of this prospectus, after deducting estimated underwriting fees and commissions and estimated offering expenses payable by us. This information is illustrative only and will depend on the actual initial public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed initial public offering price of $           per share, which is the midpoint of the price per range set forth on the cover page of this prospectus, would increase or decrease the amount of each of cash and cash equivalents, working capital, total assets and total stockholders’ equity by $            million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each increase or decrease of 1.0 million in the number of shares we are offering would increase or decrease the amount of each of cash and cash equivalents, working capital, total assets and stockholders’ equity by $              million, assuming no change in the assumed initial public offering price per share and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

 

11

 

 

RISK FACTORS

 

Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with all of the other information in this prospectus, before making a decision to invest in our common stock. The risks and uncertainties described below may not be the only ones we face. If any of the risks actually occur, our business, results of operations, financial condition and prospects could be harmed. In that event, the trading price of our common stock could decline, and you could lose part or all of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations.

 

Risks Related to the Development of our Human-on-a-Chip System

 

Our success depends upon market acceptance of our platform, our ability to develop and commercialize new services and generate revenues and our ability to identify new markets for our technology.

 

We have had limited commercial sales of our Human-on-a-Chip systems to date. Our success will depend on the acceptance of our Human-on-a-Chip systems and services in the pharmaceutical and cosmetics markets. We are faced with the risk that the marketplace will not be receptive to our systems and services over competing systems and services and that we will be unable to compete effectively. We cannot assure that our current systems or any future systems, products, and services, will successfully support the services we envision offering or gain broad market acceptance. If the market for our currently contemplated services fails to develop or develops more slowly than expected, or if any of the services and standards supported by us do not achieve or sustain market acceptance, our business and operating results would be materially and adversely affected.

 

We have historically achieved limited profitability.

 

To date, we generate revenue primarily through the receipt of grants. For the year ended December 31, 2021, our net loss is approximately $484,000, and for the three months ended March 31, 2022 our net loss is approximately $348,000. We have limited profitable operations and have generated minimal cash flow from operations since incorporation. We believe that the net proceeds from this offering, together with our existing cash and cash equivalents and grants from NIH, will be sufficient to fund our operations through at least the next 12 months. Our estimate as to how long we expect the net proceeds from this offering, together with our existing cash and cash equivalents, to be able to continue to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. Further, our future operations are dependent on the success of our efforts to raise additional capital, our research and commercialization efforts, regulatory acceptance, and, ultimately, the market acceptance of our products. If such efforts are unsuccessful or if we are unable to complete this offering, and if we sustain losses over an extended period of time, we may be unable to continue our business.

 

Our Human-on-a-Chip systems represent new approaches that could result in heightened regulatory scrutiny, including for our customers’ regulatory submissions, or our inability to achieve regulatory acceptance or commercialization of our services.

 

Our future success is dependent on the continued development of our Human-on-a-Chip systems. Because these systems represent a new approach to determining individualized responses to pharmacological agents, developing and commercializing our systems subject us to a number of unique challenges, including:

 

obtaining acceptance of the use of the results from some of our envisioned services for clinical trials that support drug approvals from the FDA and other applicable regulatory authorities who have limited experience with organ-on-chip technology;
   
developing and deploying consistent, reliable, and validated processes for manufacturing Human-on-a-Chip systems for use with services supporting pre-clinical feasibility studies;
   
sourcing supplies for the materials used to manufacture Human-on-a-Chip systems;
   
establishing sales and marketing capabilities to penetrate markets and gain market acceptance; and
   
developing systems for organs and types of diseases beyond those initially addressed by our current systems.

 

12

 

 

The regulatory acceptance for novel systems such as ours that will be used to support FDA regulatory approvals can be more expensive and take longer than for other, better known or extensively studied products. Although our services are not currently subject to regulation by the FDA, we are developing novel methods of research and testing for drug efficacy in which there is little clinical experience with new endpoints and methodologies, and there is a heightened risk that our future services may be subject to the FDA, European Medicines Agency (EMA), or comparable foreign regulatory bodies. There is no guarantee that these regulatory bodies would consider our systems to provide meaningful results, or accept them as part of the drug approval process, and that could materially affect our ability to commercialize our technology.

 

The development of new biopharmaceutical products and services that are used to support FDA regulatory approvals involves a lengthy and complex process and we may be unable to obtain regulatory acceptance for any of the platforms we are currently developing.

 

Each of our Human-on-a-Chip systems continue to be further developed and will require additional financial resources, testing, manufacturing scale-up and regulatory acceptance prior to being ready for wide-spread use in connection with certain of the applications of our services. This process can take years of effort without any assurance of ultimate success. Our development efforts could be delayed or could fail for many reasons, including:

 

the failure of our systems in preclinical studies, including failing to demonstrate sufficient durability and functionality to support further development activities; the inability to satisfy regulatory requirements;
   
adverse reactions;
   
insufficient preclinical trial data to support the effectiveness or superiority of our systems;
   
our inability to manufacture sufficient quantities of our platform for our service activities in a timely and cost-efficient manner;
   
our failure to obtain, or delays in obtaining, the required regulatory acceptance for our systems when necessary, the facilities or the process used to manufacture our systems;
   
changes in the regulatory environment, that make development of a new platform or of an existing platform for a new indication no longer attractive; and
   
the development of a competitive platform or service.

 

We cannot provide any assurance that the preclinical studies we perform using our systems will receive regulatory acceptance. Even if our systems did receive the required regulatory acceptance, there can no assurance that we could provide for the effective marketing and sale of such services, either by ourselves or in partnership with others. Accordingly, our prospects must be considered in light of the risks, expenses, and difficulties frequently encountered by companies in an early stage of drug development research services.

 

Our experience manufacturing our Human-on-a-Chip systems is limited. Manufacturing issues, including technical or quality issues, may arise that could cause delays in our development programs or increase costs.

 

Manufacturing our Human-on-a-Chip systems is complicated and presents novel technical challenges. We may encounter problems achieving adequate quantities and quality of clinical-grade materials, especially in the future if we determine it is necessary to meet FDA, EMA or other applicable standards or specifications with consistent and acceptable production yields and costs.

 

To date, we have not yet scaled up manufacturing processes beyond the scale used for research and nonclinical studies. The time and efforts required for us to develop and validate our manufacturing process to support clinical use may delay or impair our ability to move beyond pre-clinical feasibility studies.

 

13

 

 

In order to manufacture any of our Human-on-a-Chip systems on a commercial scale in the future, we will need to bolster our quality control and quality assurance capabilities, including by augmenting our manufacturing processes and adding personnel. We also may encounter problems hiring and retaining the experienced scientific and manufacturing personnel needed to operate our manufacturing process, which could result in delays in our production or difficulties in maintaining compliance with applicable regulatory requirements. As we engage in scale-up manufacturing of any approved devices and services, we may encounter unexpected issues relating to the manufacturing processes, stem cell availability, or the quality, purity or stability of the cells in the platform, and we may be required to refine or alter our manufacturing processes to address these issues. Resolving these issues could result in significant delays and may result in significantly increased costs.

 

It is often the case that early stage research is conducted with materials that are not manufactured pursuant to the FDA’s current Good Manufacturing Practice (cGMP) regulations and which are not subject to the same level of analysis that would be required for clinical grade material. We may encounter difficulties in translating the manufacturing processes used to produce research grade materials to cGMP compliant processes, and any changes in the manufacturing process may affect the efficacy profile of our systems. In addition, because early stage, pilot manufacturing is often done on a small scale, we may face challenges scaling up any early stage manufacturing to the scale necessary to support supply for future demand of our services. If we are not able to establish manufacturing or related processes in a manner required for further development of our systems, our development plans may be delayed or stalled, and our business may be materially harmed.

 

Any problems in our manufacturing process could make us a less attractive collaborator for potential partners, including pharmaceutical companies, cosmetics companies, non-profits and academic research institutions, which could limit our access to additional attractive development programs.

 

Our Human-on-a-Chip systems are novel, complex, and can be difficult to manufacture. We could experience manufacturing problems that result in delays in our development or commercialization programs or otherwise harm our business.

 

The manufacturing processes used to produce our Human-on-a-Chip systems can be complex, are novel, and have not been extensively validated for commercial use. Several factors could cause production interruptions, including equipment malfunctions, facility contamination, raw material shortages or contamination, natural disasters, disruption in utility services, human error, or disruptions in the operations of our suppliers.

 

If FDA does accept the data produced by our Human-on-a-Chip system, regulatory agencies in foreign jurisdictions may never accept such data and we may never commercialize our system in such jurisdictions, which would limit our ability to realize the full market potential of our Human-on-a-Chip system.

 

In order to eventually market our Human-on-a-Chip systems in any particular foreign jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a jurisdiction-by-jurisdiction basis regarding efficacy and utility of the platform. FDA’s willingness to accept the scientific viability of our technology in the United States, which is demonstrated by FDA issuing an IND to an industry partner that uses our technology to support such a submission, does not ensure that regulatory authorities in other countries or jurisdictions would also accept the scientific viability of our technology. Although the FDA has approved an IND using data from our systems, there is no assurance that the FDA will give similar treatment to future studies that use our systems. In the future, if the FDA ever decides that our technology does not produce data capable of supporting our partners’ IND submissions, our target market would be limited and our ability to achieve the full market potential of our platform will be unrealized. In addition, services conducted in one country may not be considered scientifically viable by regulatory authorities in other countries, and acceptance of the scientific viability of our technology by a regulatory agency in one country does not guarantee such acceptance in any other country. Regulatory processes vary among countries and can involve additional product testing and validation. Seeking foreign acceptance of the scientific viability of our technology could result in additional costs and require additional preclinical studies or validation. We do not have any platform or services that have been accepted as scientifically valid by regulatory authorities for regulatory evaluation in any jurisdiction, including international markets, and we do not have experience in obtaining regulatory acceptance in international markets. If we fail to obtain regulatory acceptance of the scientific validity of our technology in international markets, our target market would be limited and our ability to achieve the full market potential of our platform will be unrealized.

 

14

 

 

We may expend our limited resources to pursue certain organ systems and fail to capitalize on organ systems that may be more profitable or for which there is a greater likelihood of success.

 

Because we have limited financial and managerial resources, we have focused our development program on certain organ systems to date. As a result, we may forego, limit, or delay pursuit of opportunities relating to other tissues or organ systems that may later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to timely capitalize on viable services or profitable market opportunities. Our spending on current and future research and development programs and tissues or organ systems may not yield commercially viable services.

 

The industry in which we operate is highly competitive and subject to rapid technological change. If our competitors are better able to develop and market products or services that are more effective, less costly, easier to use, or are otherwise more attractive, we may be unable to compete effectively with other companies.

 

The biopharmaceutical technology industry is characterized by intense competition and rapid technological change, and we will face competition on the basis of platform or service features, price, and other factors. Competitors may include large medical device companies, academic institutions, pharmaceutical or cosmetic companies and other companies, some of which have significantly greater financial and marketing resources than we do, and firms that are more specialized than we are with respect to particular markets. Our competition may respond more quickly to new or emerging technologies, undertake more extensive marketing campaigns, have greater financial, marketing and other resources than ours or may be more successful in attracting potential customers, employees and strategic partners.

 

Our competitive position will depend on multiple, complex factors, including our ability to achieve regulatory clearance and market acceptance for our platforms and services, develop new services, implement production and marketing plans, secure regulatory approvals for devices under development and protect our intellectual property. In some instances, competitors may also offer, or may attempt to develop, alternative systems that may be delivered without a with a device superior to ours. The development of new or improved products, processes or technologies by other companies may render proposed services less competitive. The entry into the market of manufacturers located in low-cost manufacturing locations may also create pricing pressure, particularly in developing markets. Our future success depends, among other things, upon our ability to compete effectively against current technology, as well as to respond effectively to technological advances or changing regulatory requirements, and upon our ability to successfully implement our marketing strategies and execute our research and development plan. Our research and development efforts are aimed, in part, at solving increasingly complex problems, as well as creating new technologies, and we do not expect that all of our projects will be successful. If our research and development efforts are unsuccessful, our future results of operations could be materially harmed.

 

Our success will be dependent on acceptance of our platform and services by the medical community and cosmetics community.

 

Market acceptance of our devices will depend on our ability to demonstrate that the use of our devices is an attractive cost-effective alternative to existing methods of drug and cosmetic development, such as animal testing. Our ability to do so will depend on our customers’ evaluations of pre-clinical efficacy, ease of use, reliability, and cost-effectiveness of our devices.

 

Risks Related to Managing and Growing our Business

 

Our business will be adversely impacted if we are unable to successfully attract, hire and integrate additional key employees or contractors.

 

Our future success depends in part on our ability to successfully attract and then retain additional executive officers and other key employees and contractors to support and scale our research, development and services. Recruiting and retaining qualified scientific and clinical personnel is critical to our success. Competition to hire qualified personnel in our industry is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. If we are unable to attract and retain high quality personnel, our ability to pursue our research and development strategies and continue to commercialize our services will be limited, and our business, prospects, financial condition and results of operations may be adversely affected. Further, we are highly dependent on the research and development expertise of Dr. Hickman, our Chief Scientist, who is employed by us only part-time and who serves as a Professor at the University of Central Florida. If we lose the services of Dr. Hickman, our ability to implement our business strategy successfully could be seriously harmed. Further, the unavailability of Dr. Hickman to us on a full-time basis may impair our ability to grow our business.

 

15

 

 

We may require additional funding. Raising additional capital would cause dilution to our existing stockholders and may restrict our operations or require us to relinquish rights to our technologies or to our systems.

 

Other than certain limited SBIR grants from the NIH, we currently do not have any committed external source of funds and it is uncertain whether our projected revenues will be sufficient to meet our operating requirements in the future. We have based our capital needs on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect if our operating plans change. If our board of directors decides that we should pursue additional research and development activities than already contemplated, we will require additional funding to operate our proposed business, including expanding our facilities and hiring additional qualified personnel, and we would expect to finance these cash needs through a combination of equity offerings, debt financings, government or other third-party funding and licensing or collaboration arrangements.

 

We have been funded in part by government grant awards, which is not a guaranteed source of funding.

 

The funding of government programs is dependent on budgetary limitations, Congressional appropriations and administrative allotment of funds, and changes in national health and welfare priorities, all of which are inherently uncertain and may be affected by changes in U.S. government policies resulting from various political and military developments. Our continued receipt of government funding is also dependent on the ability to adhere to the terms and provisions of the original grant and contract documents and other regulations. We can provide no assurance that we will receive or continue to receive funding for grants and contracts that we have been awarded. The loss of government funds could have a material adverse effect on our business, financial condition, and results of operations.

 

If we are not able to enhance our reputation and brand recognition, we may not be able to execute our business strategy as planned.

 

We believe that enhancing our reputation and brand recognition is critical to maintaining our relationships and to our ability to attract new customers and strategic partners. The promotion of our brand may require us to make substantial investments and we anticipate that, as our market becomes increasingly competitive, these marketing initiatives may become increasingly difficult and expensive. Our marketing activities may not be successful or yield increased revenue, and to the extent that these activities yield increased revenue, the increased revenue may not offset the expenses we incur and our results of operations could be harmed. In addition, any factor that diminishes our reputation or that of our management, including failing to meet the expectations of our customers, or any adverse publicity surrounding one of our investors or customers, could make it substantially more difficult for us to attract new customers. If we do not successfully enhance our reputation and brand recognition, our business may not grow and we could lose our relationships with existing customers, which would harm our business, results of operations, and financial condition.

 

We may acquire other companies or technologies, which could divert our management’s attention, result in dilution to our stockholders, and otherwise disrupt our operations and we may have difficulty integrating any such acquisitions successfully or realizing the anticipated benefits therefrom, any of which could have an adverse effect on our business, financial condition, and results of operations.

 

We may seek to acquire or invest in businesses, applications, and services, or technologies that we believe could complement or expand our service offerings, enhance our capabilities, or otherwise offer growth opportunities. The pursuit of potential acquisitions may divert the attention of management and cause us to incur various expenses in identifying, investigating, and pursuing suitable acquisitions, whether or not they are consummated. We may have difficulty integrating other technologies or other team members, and we may not be able to achieve the intended benefits from any such acquisition.

 

In addition, a significant portion of the purchase price of companies we acquire may be allocated to acquired goodwill and other intangible assets, which must be assessed for impairment at least annually. In the future, if our acquisitions do not yield expected returns, we may be required to take charges to our results of operations based on this impairment assessment process, which could adversely affect our results of operations.

 

Acquisitions could also result in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our results of operations. In addition, if an acquired business fails to meet our expectations, our business, financial condition, and results of operations may suffer.

 

16

 

 

Improper performance of our services will negatively impact our reputation.

 

The performance of clinical development services is complex and time-consuming. For example, we may make mistakes in conducting a pre-clinical developmental plan that could negatively impact or obviate the usefulness of the services or cause the results of the pre-clinical evaluation to be reported improperly. If the platform results are compromised, we could be subject to significant costs or liability, which could have an adverse impact on our ability to perform our services. Improper performance of our services could have an adverse effect on our financial condition, damage our reputation and result in the cancellation of current contracts by or failure to obtain future contracts from the affected client or other clients.

 

Investigation of clients could result in liability to us.

 

From time to time, one or more of our clients may be audited or investigated by regulatory authorities or enforcement agencies with respect to regulatory compliance of their clinical trials, programs or the marketing and sale of their drugs. In these situations, we would have provided services to our clients with respect to the pre-clinical evaluation, programs or activities being audited or investigated, and we would be called upon to respond to requests for information by the authorities and agencies. There is a risk that either our clients or regulatory authorities could claim that we performed our services improperly. If our clients or regulatory authorities make such claims against us and prove them, we could be subject to damages, fines or penalties. In addition, negative publicity regarding regulatory compliance of our clients’ clinical trials, programs or drugs could have an adverse effect on our business and reputation.

 

Our business may be materially and adversely impacted by factors affecting the biopharmaceutical and healthcare industries.

 

We expect that the majority of our commercial revenue is generated from sales to the biopharmaceutical and healthcare industries. The clients we serve in these industries are subject to financial pressures, including, but not limited to, increased costs, reduced demand for their products, reductions in pricing and reimbursement for products and services, formulary approval and placement, government approval to market their products and limits on the manner by which they market their products, loss of patent exclusivity (whether due to patent expiration or as a result of a successful legal challenge) and the proliferation of or changes to regulations applicable to these industries. To the extent our clients face such pressures, or they change how they utilize our offerings, the demand for our services, or the prices our clients are willing to pay for those services, may decline. Any such decline could have a material adverse effect on our business, operating results and financial condition.

 

Global or regional health pandemics or epidemics, including COVID-19, could negatively impact our business operations, financial performance and results of operations.

 

Our business and financial results could be negatively impacted by COVID-19 and its variants or other pandemics or epidemics. The severity, magnitude and duration of pandemics are uncertain, rapidly changing and hard to predict. During 2020 and 2021, COVID-19 significantly impacted economic activity and markets around the world. COVID-19 and its variants or other pandemics could negatively impact our future business in numerous ways, including but not limited to those outlined below:

 

Disruptions or uncertainties related to a pandemic for a sustained period of time could result in delays or modifications to our strategic plans and initiatives and hinder our ability to achieve our business objectives. For example during the COVID-19 outbreak, certain materials, such as computer chips, helium and live cells, necessary to complete active projects were, and continue to be, difficult to acquire due to disruptions in the global supply chain. Further disruptions to the global supply chain and our ability to obtain materials necessary for our operation would adversely affect our business objectives.

   

Illness, travel restrictions or workforce disruptions could negatively affect our research and other business processes. For example, during the COVID-19 outbreak, customer receivables and internal operations were delayed or suspended with respect to completed and active contract work due to personnel absence as a result of exposure to the virus or the need to care for dependents that may have been exposed. These delays led to a delay in the completion of active projects and delay in the collection of the associated accounts receivable.

 

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Government or regulatory responses to pandemics could negatively impact our business. Mandatory lockdowns or other restrictions could materially adversely impact our operations and results but government financial assistance such as the Paycheck Protection Loan program may offset a portion of the adverse impact.
   

During the height of the COVID-19 outbreak, there was increased volatility and pricing in the capital markets. If such volatility continues, it could have a material adverse effect on our ability to obtain debt or equity financing to fund operations. Economic uncertainties or downturns in the general economy or the healthcare industry in general could disproportionately affect the demand for our service offerings and materially adversely affect our results of operations.

 

While we believe the economic impact brought by COVID-19 has not materially impacted our results of operations, the widespread pandemic and resulting impact upon supply chains and inflation has resulted in significant disruption of global financial markets, which could reduce our ability to access capital and negatively affect our future liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 and related government orders and restrictions could materially affect our business and the value of our common stock. If the NIH should divert research funding to other areas or if the cosmetics industry or pharmaceutical industry reduced funding for their studies and pre-clinical feasibility trials, it would have a material affect our business, financial condition and results of operations. The ultimate impact of the COVID-19 pandemic or a similar health epidemic is highly uncertain and subject to change.

 

These and other impacts of the COVID-19 or other global or regional health pandemics or epidemics could have the effect of heightening many of the other risks described in this “Risk Factors” section. We might not be able to predict or respond to all impacts on a timely basis to prevent near- or long-term adverse impacts to our results. The ultimate impact of these disruptions also depends on events beyond our knowledge or control, including the duration and severity of any outbreak and actions taken by parties other than us to respond to them. Any of these disruptions could have a negative impact on our business operations, financial performance and results of operations, which impact could be material.

 

Global, market and economic conditions may negatively impact our business, financial condition and share price.

 

Concerns over inflation, geopolitical issues, global financial markets and the COVID-19 pandemic have led to increased economic instability, diminished expectations for the global economy and expectations of slower global economic growth. Our general business may be adversely affected by any such economic instability or unpredictability. Trade sanctions and disruptions to the global economy have led to additional inflation which may negatively impact the global supply chain and could have a material adverse effect on our ability to secure supplies. These conditions will likely increase our costs in the form of higher wages, more expensive supplies and equipment necessary to operate our business. If conditions worsen or do not improve, it may become more difficult for us to complete debt or equity financings which may be necessary for us to operate our business. Such financings may become more costly, difficult to complete, and more dilutive. In addition, there is a risk that one or more of our suppliers or other partners could be negatively affected by global economic instability, which could adversely affect our ability to operate efficiently and timely complete our operational goals. We intend to mitigate the impact of inflation by further automating our processes and by passing our costs on to our customers through higher charges for future projects. There can be no assurance that we will succeed in further automating our processes or be able to charge more for our future services.

 

Risks Related to Protecting Our Technology and Intellectual Property

 

Any failure to protect our intellectual property rights could impair our ability to protect our proprietary technology and our brand.

 

Our success and ability to compete depend largely upon our intellectual property. To date, we have 13 patents issued and six patent applications pending in the U.S., with two of the pending applications jointly-owned by us and the University of Central Florida. We also have 17 patents issued and four patent applications pending outside the U.S., with three of the pending applications jointly-owned by us and the University of Central Florida. All of the issued patents are solely owned by the University of Central Florida and licensed to us. We take reasonable steps to protect our intellectual property, especially when working with third parties. However, the steps we take to protect our intellectual property rights may be inadequate. For example, other parties, including our competitors, may independently develop similar technology, duplicate our services, or design around our intellectual property and, in such cases, we may not be able to assert our intellectual property rights against such parties. Further, our contractual arrangements may not effectively prevent disclosure of our confidential information or provide an adequate remedy in the event of unauthorized disclosure of our confidential information, and we may be unable to detect the unauthorized use of, or take appropriate steps to enforce, our intellectual property rights.

 

We make business decisions about when to seek patent protection for a particular technology and when to rely upon trade secret protection, and the approach we select may ultimately prove to be inadequate. Even in cases where we seek patent protection, there is no assurance that the resulting patents will effectively protect every significant feature of our technology or proprietary information, or provide us with any competitive advantages. Moreover, we cannot guarantee that any of our pending patent applications will issue or be approved. The United States Patent and Trademark Office and various foreign governmental patent agencies also require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent application process and after a patent has issued. There are situations in which noncompliance can result in abandonment or lapse of the patent, or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If this occurs, our competitors might be able to enter the market, which would have a material adverse effect on our business. Effective trademark, copyright, patent, and trade secret protection may not be available in every country in which we conduct business. Further, intellectual property law, including statutory and case law, particularly in the United States, is constantly developing, and any changes in the law could make it harder for us to enforce our rights.

 

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In order to protect our intellectual property rights, we may be required to spend significant resources to monitor and protect these rights. Litigation brought to protect and enforce our intellectual property rights could be costly, time-consuming, and distracting to management and could result in the impairment or loss of portions of our intellectual property. Furthermore, our efforts to enforce our intellectual property rights may be met with defenses, counterclaims, and countersuits attacking the validity and enforceability of our intellectual property rights. An adverse determination of any litigation proceedings could put our intellectual property at risk of being invalidated or interpreted narrowly and could put our related pending patent applications at risk of not issuing. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential or sensitive information could be compromised by disclosure in the event of litigation. In addition, during the course of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Negative publicity related to a decision by us to initiate such enforcement actions against a client or former client, regardless of its accuracy, may adversely impact our other client relationships or prospective client relationships, harm our brand and business, and could cause the market price of our common stock to decline. Our failure to secure, protect, and enforce our intellectual property rights could adversely affect our brand and our business.

 

We rely on licenses from third parties to certain technology and intellectual property rights for some of our services and the licenses we currently have could terminate or expire.

 

Some of our business services rely on technology or intellectual property rights owned and controlled by others. Our licenses to this technology or these intellectual property rights could be terminated or could expire. We may be unable to replace these licenses in a timely manner. Failure to renew these licenses, renewals of these licenses on less advantageous terms, or termination of these licenses may limit the amount and type of services that we may provide depending on the intellectual property rights relied upon by our services and could harm our operating results and financial condition.

 

Intellectual property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.

 

We have patent applications that were generated through the use of U.S. government funding or grants, including grants from the NIH, and may acquire or license in the future intellectual property rights that have been generated through the use of U.S. government funding or grants. Pursuant to the Bayh-Dole Act of 1980, the U.S. government has certain rights in inventions developed with government funding. These U.S. government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third-party if it determines that: (1) adequate steps have not been taken to commercialize the invention; (2) government action is necessary to meet public health or safety needs; or (3) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”). If the U.S. government exercised its march-in rights in our future intellectual property rights that are generated through the use of U.S. government funding or grants, we could be forced to license or sublicense intellectual property developed by us or that we license on terms unfavorable to us, and there can be no assurance that we would receive compensation from the U.S. government for the exercise of such rights. The U.S. government also has the right to take title to these inventions if the grant recipient fails to disclose the invention to the government or fails to file an application to register the intellectual property within specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources. In addition, the U.S. government requires that any products embodying any of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States. This preference for U.S. industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property.

 

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We may not be able to adequately defend against piracy of intellectual property in foreign jurisdictions.

 

Considerable research in drug research and development is being performed in countries outside of the United States, and a number of potential competitors are located in these countries. The laws protecting intellectual property in some of those countries may not provide adequate protection to prevent our competitors from misappropriating our intellectual property. Several of these potential competitors may be further along in the process of product or service development and also operate large, company-funded research and development programs. As a result, our competitors may develop more competitive or affordable products, or achieve earlier patent protection or device commercialization than we are able to achieve. Competitive devices may render any services that we develop obsolete.

 

We may be sued by third parties for alleged infringement of their proprietary rights or misappropriation of intellectual property.

 

There is considerable patent and other intellectual property development activity in our industry. Our future success depends in part on not infringing upon the intellectual property rights of others. Our competitors, as well as a number of other entities and individuals, may own or claim to own intellectual property relating to our business. From time to time, third parties may claim that we are infringing upon their intellectual property rights or that we have misappropriated their intellectual property. For example, in some cases, very broad patents are granted that may be interpreted as covering a wide field of drug development systems. As competition in our market grows, the possibility of patent infringement, trademark infringement, and other intellectual property claims against us increases. In the future, others may claim that our Human-on-a-Chip systems and underlying technology infringe or violate their intellectual property rights. In a patent infringement claim against us, we may assert, as a defense, that we do not infringe the relevant patent claims, that the patent is invalid or both. The strength of our defenses will depend on the patents asserted, the interpretation of these patents, and our ability to invalidate the asserted patents. However, we could be unsuccessful in advancing non-infringement and/or invalidity arguments in our defense. In the United States, issued patents enjoy a presumption of validity, and the party challenging the validity of a patent claim must present clear and convincing evidence of invalidity, which is a high burden of proof. Conversely, the patent owner need only prove infringement by a preponderance of the evidence, which is a lower burden of proof. We may be unaware of the intellectual property rights that others may claim cover some or all of our technology or services. Because patent applications can take years to issue and are often afforded confidentiality for some period of time there may currently be pending applications, unknown to us, that later result in issued patents that could cover one or more aspects of our technology and services. Any claims or litigation could cause us to incur significant expenses and, whether or not successfully asserted against us, could require that we pay substantial damages, ongoing royalty or license payments, or settlement fees, prevent us from offering our services or using certain technologies, require us to re-engineer all or a portion of our models, or require that we comply with other unfavorable terms. We may also be obligated to indemnify our clients or business partners or pay substantial settlement costs, including royalty payments, in connection with any such claim or litigation and to obtain licenses, modify applications, or refund fees, which could be costly. Even if we were to prevail in such a dispute, any litigation regarding our intellectual property could be costly and time-consuming and divert the attention of our management and key personnel from our business operations.

 

Risks Related to Governmental Regulations

 

Government regulation of healthcare creates risks and challenges with respect to our compliance efforts and our business strategies.

 

The healthcare and pharmaceutical industries are highly regulated and are subject to changing political, legislative, regulatory, and other influences. Laws and regulations affecting the healthcare and pharmaceutical industries, or changes to existing laws and regulations, including the possible enactment of federal or state health care reforms and possible changes to other federal, state or local laws or regulations affecting the health care and pharmaceutical industries, could create unexpected liabilities for us, cause us to incur additional costs, and restrict our operations. Reforming the healthcare and pharmaceutical industries has been a priority for U.S. politicians, and key members of the legislative and executive branches have proposed a wide variety of potential changes and policy goals. Certain changes to laws could affect our business and results of operations.

 

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On April 15, 2021 H.R.2565 was introduced to the 117th US House of Representatives to require the FDA modernization act of 2021. This bill allows an applicant for market approval for a new drug to use methods other than animal testing to establish the drug’s safety and effectiveness. Under this bill, these alternative methods may include cell-based assays, organ chips and microphysiological systems, sophisticated computer modeling, and other human biology-based test methods. Although neither of these potential new regulations have been enacted, there is a risk that more stringent regulations could increase the cost to generate and employ our cells on a chip system. This law and the articles above provide evidence of the regulatory agency’s “acceptance” of our new organ-on-a-chip testing methodology.

 

Many healthcare and pharmaceutical laws are complex, and their application to specific products, services and relationships may not always be clear. In particular, many existing or future healthcare laws and regulations may be applied to our systems and service offerings in ways that we do not anticipate, particularly as we develop and release new and more sophisticated solutions. Our failure to accurately anticipate the application of these laws and regulations, or our other failure to comply with them, could create significant liability for us, result in adverse publicity, and negatively affect our business.

 

Health Data Privacy Laws. There are numerous federal and state laws related to health information privacy. In particular, the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and their implementing regulations, which we collectively refer to as “HIPAA,” include privacy standards that protect individual privacy by limiting the uses and disclosures of personal health information (PHI) and implementing data security standards that require covered entities to implement administrative, physical, and technological safeguards to ensure the confidentiality, integrity, availability, and security of PHI in electronic form. In addition to enforcement actions initiated by regulatory bodies under HIPAA, violations or breaches caused by us or our contractors may result in related claims against us by our clients. If we were to process and maintain PHI on behalf of our covered entity clients, we may be a HIPAA business associate and mandated by HIPAA to enter into written agreements with our covered entity clients — known as Business Associate Agreements (“BAAs”) — that require us to safeguard PHI. BAAs typically include:

 

a description of our permitted uses of PHI;
   
a covenant not to disclose that information except as permitted under the BAA and to require that our subcontractors, if any, are subject to the substantially similar restrictions;
   
assurances that reasonable and appropriate administrative, physical, and technical safeguards are in place to prevent misuse of PHI;
   
an obligation to report to our client any use or disclosure of PHI other than as provided for in the BAA;
   
a prohibition against our use or disclosure of PHI if a similar use or disclosure by our client would violate the HIPAA standards;
   
the ability of our clients to terminate the underlying support agreement if we breach a material term of the BAA and are unable to cure the breach;
   
the requirement to return or destroy all PHI at the end of our services agreement; and
   
access by the Department of Health and Human Services (“HHS”) to our internal practices, books, and records to validate that we are safeguarding PHI.

 

In addition, we may also be required to maintain BAAs, which contain similar provisions, with our subcontractors that access or otherwise process PHI on our behalf.

 

We may not be able to adequately address the business risks created by HIPAA implementation, and meet the requirements imposed by HIPAA. Furthermore, we are unable to predict what changes to HIPAA or other laws or regulations might be made in the future or how those changes could affect our business or the costs of compliance.

 

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In addition to the HIPAA privacy and security standards, most states have enacted patient confidentiality laws that protect against the disclosure of confidential medical and other personally identifiable information (“PII”) and many states have adopted or are considering new privacy laws, including legislation that would mandate new privacy safeguards, security standards, and data security breach notification requirements. Such state laws, if more stringent than HIPAA requirements, are not preempted by the federal requirements, and we are required to comply with them. In addition, the Federal Trade Commission, and analogous state agencies, may apply consumer protection laws to the context of data privacy. For example, the Federal Trade Commission has sanctioned companies for unfair trade practices when they failed to implement adequate security protection measures for sensitive personal information.

 

Failure by us to comply with any of the federal and state standards regarding patient privacy and/or privacy more generally may subject us to penalties, including significant civil monetary penalties and, in some circumstances, criminal penalties. In addition, such failure may injure our reputation and adversely affect our ability to retain clients and attract new clients.

 

The FDA can also impose extensive requirements governing pre- and post-market conditions, such as service investigation and others relating to approval, labeling, and manufacturing. In addition, the FDA can impose extensive requirements governing software development controls and quality assurance processes.

 

We cannot predict the ultimate form of any regulation and the potential impact on our tests or materials used to perform our tests. If pre-market clearance or approval is required, our business could be negatively impacted until such review is completed and clearance or approval to market is obtained. The FDA could require that we seek pre-market clearance or approval for our analytical services or require that we stop selling our analytical services until we have successfully secured such pre-market clearance or approval. If our analytical services are allowed to remain on the market but there is regulatory uncertainty about our analytical services, e.g., if they are labeled investigational by the FDA, or if labeling claims the FDA allows us to make are limited, orders may decline. The regulatory clearance or approval process may involve, among other things, successfully completing trials and submitting a pre-market clearance notice or filing an application with the FDA. If pre-market clearance or approval is required by the FDA, there can be no assurance that our analytical services will be cleared or approved on a timely basis, if at all, nor can there be assurance that labeling claims will be consistent with our current claims or adequate to support continued use of our analytical services. An increase in FDA regulatory compliance burdens would increase the cost of conducting our business, and subject us to inspection by the FDA and potentially penalties for failure to comply with these regulatory requirements. We may also decide to voluntarily pursue FDA pre-market clearance or approval of our analytical services if we determine that doing so would be appropriate or competitively advantageous.

 

In the event we are required to or voluntarily choose to become subject to FDA clearance or approval, we may become subject to compliance with significant FDA regulatory requirements.

 

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Risks Related to Operating as a Public Company

 

The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified board members.

 

As a public company, we will be subject to the reporting requirements of the Securities Exchange Act of 1934 (the Exchange Act), the listing standards of Nasdaq and other applicable securities rules and regulations. We expect that the requirements of these rules and regulations will increase our legal, accounting, and financial compliance costs, make some activities more difficult, time-consuming, and costly, and place significant strain on our personnel, systems, and resources. As a result of the complexity involved in complying with the rules and regulations applicable to public companies, our management’s attention may be diverted from other business concerns, which could harm our business, results of operations, and financial condition.

 

We also expect that being a public company will make it more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult for us to attract and retain qualified members of our board of directors, particularly to serve on our audit committee and compensation committee, and qualified executive officers.

 

As a result of disclosure of information in filings required of a public company, our business and financial condition is more visible, which may result in an increased risk of threatened or actual litigation, including by competitors and other third parties. If such claims are successful, our business and results of operations could be harmed, and even if the claims do not result in litigation or are resolved in our favor, these claims, and the time and resources necessary to resolve them, could divert the resources of our management and harm our business, results of operations, and financial condition.

 

The individuals who now constitute our senior management team have limited experience managing a publicly-traded company and limited experience complying with the increasingly complex laws pertaining to public companies. Our senior management team may not successfully or efficiently manage our transition to a public company that is subject to significant regulatory oversight and reporting obligations.

 

We are an emerging growth company, and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.

 

We are an emerging growth company, and, for as long as we continue to be an emerging growth company, we expect to take advantage of exemptions from various reporting requirements applicable to other public companies but not to “emerging growth companies,” including:

 

not being required to have our independent registered public accounting firm attest to our internal control over financial reporting under Section 404 of the Sarbanes Oxley Act;
 
reduced disclosure obligations regarding executive compensation in our periodic reports and annual report on Form 10-K; and
   
exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

 

We could be an emerging growth company for up to five years following the completion of this offering. Our status as an emerging growth company will end as soon as any of the following takes place:

 

the last day of the fiscal year in which we have more than $1.07 billion in annual revenue;
   
the date we qualify as a “large accelerated filer,” with at least $700 million of equity securities held by non-affiliates;
   
the date on which we have issued, in any three-year period, more than $1.0 billion in non-convertible debt securities; or
   
the last day of the fiscal year ending after the fifth anniversary of the completion of this offering.

 

We cannot predict if investors will find our common stock less attractive if we choose to rely on the exemptions afforded emerging growth companies. If some investors find our common stock less attractive because we rely on any of these exemptions, there may be a less active trading market for our common stock and the market price of our common stock may be more volatile.

 

Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards apply to private companies.

 

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If we are unable to implement and maintain effective internal control over financial reporting in the future, our ability to produce accurate financial statements could be impaired, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock may decline.

 

As a result of this offering, we will become subject to the information and reporting requirements of the Securities Exchange Act and, in accordance with this law, we will file periodic reports (Form 10-K’s, Form 10-Q’s and Form 8-K’s), proxy statements and other information with the Securities and Exchange Commission. Upon becoming a public reporting company, we will be required to maintain internal control over financial reporting and to report any material weaknesses in such internal control. We will also be required to establish and maintain effective disclosure controls. In addition, beginning with our second annual report on Form 10-K following this offering, we will be required to furnish a report by management on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act. We are in the process of designing, implementing and testing the internal control over financial reporting required to comply with this obligation, which process is time consuming, costly and complicated. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting beginning with our annual report on Form 10-K following the date on which we are no longer an “emerging growth company,” which may be up to five full years following the date of this offering. If we identify material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements of Section 404 in a timely manner or assert that our internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting when required, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could be negatively affected, and we could become subject to investigations by the stock exchange on which our securities are listed, the SEC or other regulatory authorities, which could require additional financial and management resources.

 

Risks Related to Investing in Our Common Stock

 

An active trading market may not develop for our securities, and you may not be able to sell your common stock at or above the offering price per share.

 

This is the initial public offering of our securities and there is currently no public market for our common stock.

 

We have applied to list our common stock on the Nasdaq Capital Market. However, we cannot predict the extent to which investor interest in our Company will lead to the development of an active trading market in our common stock or how liquid that market might become. If such a market does not develop or is not sustained, it may be difficult for you to sell your shares of common stock at the time you wish to sell them, at a price that is attractive to you, or at all.

 

The trading market for our common stock in the future could be subject to wide fluctuations in response to several factors, including, but not limited to:

 

overall performance of the equity markets and/or publicly-listed technology or healthcare companies;
   
actual or anticipated fluctuations in our net revenue or other operating metrics;
   
changes in the financial projections we provide to the public or our failure to meet these projections;
   
failure of securities analysts to initiate or maintain coverage of us, changes in financial estimates by any securities analysts who follow our Company, or our failure to meet the estimates of securities analysts or the expectations of investors;

 

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the economy as a whole and market conditions in our industry;
   
rumors and market speculation involving us or other companies in our industry;
   
announcements by us or our competitors of significant innovations, acquisitions, strategic partnerships, joint ventures, or capital commitments;
   
new laws or regulations or new interpretations of existing laws or regulations applicable to our business;
   
limited trading volume in our common stock due to the large percentage ownership by controlling stockholders;
   
lawsuits threatened or filed against us;
   
recruitment or departure of key personnel;
   
other events or factors, including those resulting from war, incidents of terrorism, or responses to these events; and
   
the expiration of contractual lock-up or market standoff agreements.

 

Furthermore, 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. Additionally, moving forward we anticipate having a limited number of shares in our public float, and as a result, there could be extreme fluctuations in the price of our common stock. The offering price per share has been determined through negotiation between us and representatives of the underwriter and may not be indicative of the market prices that prevail after this offering. You may not be able to sell your common stock at or above the offering price per share.

 

Our management has broad discretion in the use of proceeds from our offering and our use may not produce a positive rate of return.

 

The principal purposes of our offering are to increase our capitalization and financial flexibility, create a public market for our stock and thereby enable access to the public equity markets by our employees and stockholders, obtain additional capital, and strengthen our position in the market. We will utilize the funds to strengthen our management team, invest heavily in automation of our system to decrease cost and increase reliability and increase our intellectual capital at the Company by hiring experienced personnel. We plan to use the remaining net proceeds for working capital, other general corporate purposes and potential acquisitions. Our management has broad discretion over the specific use of the net proceeds we received in our offering and might not be able to obtain a significant return, if any, on investment of these net proceeds. Investors will need to rely upon the judgment of our management with respect to the use of proceeds. If we do not use the net proceeds that we received in our offering effectively, our business, results of operations, and financial condition could be harmed.

 

The issuance of additional capital stock in connection with financings, acquisitions, investments, our Omnibus Incentive Plan or otherwise will dilute all other stockholders.

 

We may need to raise additional capital through equity and debt financings in order to fund our operations. If we raise capital through equity financings in the future, that will result in dilution to all other stockholders. We also expect to grant equity awards to employees, directors, and consultants under our Omnibus Incentive Plan. As part of our business strategy, we may acquire or make investments in complementary companies, platforms, or technologies and issue equity securities to pay for any such acquisition or investment. Any such issuances of additional capital stock may cause stockholders to experience significant dilution of their ownership interests and the per-share value of our common stock to decline.

 

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We do not currently intend to pay dividends on our common stock and, consequently, the ability of common stockholders to achieve a return on investment will depend on appreciation, if any, in the price of our common stock.

 

You should not rely on an investment in our common stock to provide dividend income. We do not plan to declare or pay any dividends on our capital stock in the foreseeable future. Instead, we intend to retain any earnings to finance the operation and expansion of our business. As a result, common stockholders may only receive a return on investment if the market price of our common stock increases.

 

Certain of our founding stockholders will continue to own a significant percentage of our common stock and will be able to exert significant control over matters subject to stockholder approval.

 

Dr. Hickman beneficially owns 85.5% of our total voting power and after this offering is completed the Company will continue to be controlled by Dr. Hickman. Upon the closing of this offering, Dr. Hickman will beneficially own approximately    % of the voting power of our outstanding Common Stock, or approximately        % if the underwriter exercises its option to purchase additional shares of Common Stock from us in full. After this offering, Dr. Hickman will have the ability to substantially influence us through this ownership position. For example, Dr. Hickman may be able to control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction. The interests of Dr. Hickman may not always coincide with our corporate interests or the interests of other stockholders, and Dr. Hickman may act in a manner with which you may not agree or that may not be in the best interests of our other stockholders. So long as Dr. Hickman continues to beneficially own a significant amount of our equity, he will continue to be able to strongly influence or effectively control our decisions.

 

As a “controlled company” under the rules of the Nasdaq Capital Market, we may choose to exempt our Company from certain corporate governance requirements that could have an adverse effect on our public stockholders;

 

One of our founding shareholders, Dr. Hickman, beneficially owns more than 50% of our total voting power. Upon the closing of this offering, Dr. Hickman will continue to own a controlling interest in us and we will meet the definition of a “controlled company” under the corporate governance standards for Nasdaq listed companies and we will be eligible to utilize certain exemptions from the corporate governance requirements of the Nasdaq Stock Market. We are a “controlled company” within the meaning of Nasdaq Listing Rule 5615(c). As a controlled company, we qualify for, and intend to rely upon, several of Nasdaq’s corporate governance requirements, including requirements that:

 

a majority of the board of directors consist of independent directors
   
compensation of officers be determined or recommended to the board of directors by a majority of its independent directors or by a compensation committee comprised solely of independent directors; and
   
director nominees be selected or recommended to the board of directors by a majority of its independent directors or by a nominating committee that is composed entirely of independent directors.

 

As long as Dr. Hickman owns at least 50% of the voting power of our Company, we are a “controlled company” as defined under Nasdaq Marketplace Rules.

 

Accordingly, to the extent that we may choose to rely on one or more of these exemptions, our stockholders would not be afforded the same protections generally as stockholders of other Nasdaq-listed companies for so long as these stockholders are collectively able to control the composition of our board and our board determines to rely upon one or more of such exemptions.

 

If you purchase our securities in this offering, you will incur immediate and substantial dilution in the book value of your investment.

 

The initial public offering price is substantially higher than the net tangible book value per share of our securities. Investors purchasing shares of common stock in this offering will pay a price per share that substantially exceeds the book value of our tangible assets after subtracting our liabilities. As a result, investors purchasing shares in this offering will incur immediate dilution of $         per share, based on the assumed initial public offering price of $        per share, which is the midpoint of the price range set forth on the cover of this prospectus.

 

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We might not be able to maintain the listing of our common stock on the Nasdaq Capital Market.

 

We have applied to list our common stock on the Nasdaq Capital Market in connection with this offering. We will not consummate this offering if our application is not approved. However, there can be no assurance that we will be able to maintain the listing standards of that exchange, which includes requirements that we maintain our stockholders’ equity, total value of shares held by unaffiliated stockholders, and market capitalization above certain specified levels. If we fail to conform to the Nasdaq listing requirements on an ongoing basis, our common stock might cease to trade on the Nasdaq Capital Market exchange, and may move to the OTCQB or OTC Pink Markets operated by OTC Markets Group, Inc. These quotation services are generally considered to be markets that are less efficient, and to provide less liquidity in the shares, than the Nasdaq Capital Market.

 

Future sales of our common stock, or the perception that future sales may occur, may cause the market price of our common stock to decline, even if our business is doing well.

 

Sales of substantial amounts of our common stock in the public market after this offering, or the perception that these sales may occur, could materially and adversely affect the price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. The shares of common stock sold in this offering will be freely tradable, without restriction, in the public market, except for any shares sold to our affiliates.

 

Approximately         shares of common stock may be sold in the public market by our directors and executive officers on or about 366 days after the date of this prospectus, subject to volume and other limitations imposed under the federal securities laws. Approximately         shares of common stock may be sold in the public market by our other stockholders on or about 181 days after the date of this prospectus, subject to volume and other limitations imposed under the federal securities laws. Sales of substantial amounts of our common stock in the public market after the completion of this offering, or the perception that such sales could occur, could adversely affect the market price of our common stock and could materially impair our ability to raise capital through offerings of our common stock. See the section entitled “Shares Eligible for Future Trading” for a more detailed description of the restrictions on selling shares of our common stock after this offering.

 

In addition, as of June 30, 2022, we had 406,200 shares of unvested restricted common stock that, if fully vested and exercised, would result in the issuance of shares of common stock. All of the shares of common stock and the shares reserved for future issuance under our Omnibus Incentive Plan will be registered for public resale under the Securities Act. Accordingly, these shares will be able to be freely sold in the public market upon issuance, subject to existing lock-up or market standoff agreements, volume limitations under Rule 144 for our executive officers and directors, and applicable vesting requirements.

 

A possible “short squeeze” due to a sudden increase in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.

 

Following this offering, investors may purchase our common stock to hedge existing exposure in our common stock or to speculate on the price of our common stock. Speculation on the price of our common stock may involve long and short exposures. To the extent aggregate short exposure exceeds the number of shares of our common stock available for purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock for delivery to lenders of our common stock. Those repurchases may in turn, dramatically increase the price of our common stock until investors with short exposure are able to purchase additional common stock to cover their short position. This is often referred to as a “short squeeze.” A short squeeze could lead to volatile price movements in our common stock that are not directly correlated to the performance or prospects of our common stock and once investors purchase the shares of common stock necessary to cover their short position the price of our common stock may decline.

 

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If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock price and trading volume could decline.

 

The trading market for our common stock will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts do not currently, and may never, publish research on our Company. If no securities or industry analysts commence coverage of our Company, the trading price for our common stock would likely be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. In addition, if our operating results fail to meet the forecast of analysts, our stock price would likely decline. If one or more of these analysts cease coverage of our Company or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our stock price and trading volume to decline.

 

Provisions in our charter documents and under Delaware law could make an acquisition of our Company more difficult, limit attempts by our stockholders to replace or remove our current board of directors and limit the market price of our common stock.

 

Provisions in our amended and restated certificate of incorporation and bylaws may have the effect of delaying or preventing a change of control or changes in our management. Our amended and restated certificate of incorporation and bylaws, include provisions that:

 

permit the board of directors to establish the number of directors and fill any vacancies and newly-created directorships; and;
   
provide that the board of directors is expressly authorized to make, alter, or repeal our bylaws

 

Moreover, Section 203 of the Delaware General Corporation Law may discourage, delay, or prevent a change in control of our Company. Section 203 imposes certain restrictions on mergers, business combinations, and other transactions between us and holders of 15% or more of our common stock.

 

Our Amended and Restated Certificate of Incorporation and our Amended and Restated Bylaws provide that derivative actions brought on our behalf, actions against our directors, officers, employees or agent for breach of fiduciary duty and certain other actions may be brought only in the Court of Chancery in the State of Delaware (or, if the Court of Chancery lacks jurisdiction, the federal district court for the District of Delaware unless said court lacks subject matter jurisdiction in which case the Superior Court of the State of Delaware) and the stockholders shall be deemed to have consented to this choice of forum provision, which may have the effect of discouraging lawsuits against our directors, officers, other employees or agents.

 

Our Amended and Restated Certificate of Incorporation and our Amended and Restated Bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware (or, if the Court of Chancery lacks jurisdiction, the federal district court for the District of Delaware unless said court lacks subject matter jurisdiction in which case the Superior Court of the State of Delaware) will be the sole and exclusive forum for any stockholder for (a) any derivative action or proceeding brought on our behalf, (b) any action asserting a claim of breach of a fiduciary duty owed by, or other wrongdoing by, any director, officer, employee or agent of the Company to the Company or the Company’s stockholders, (c) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law (“DGCL”) or the Company’s Certificate of Incorporation or Bylaws, (d) any action to interpret, apply, enforce or determine the validity of the Company’s Certificate of Incorporation or Bylaws, or (e) any action asserting a claim governed by the internal affairs doctrine. The federal district courts of the United States of America shall be the exclusive forum for the resolution of any complaint, claim or proceeding asserting a cause of action arising under the Exchange Act or the Securities Act. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. Stockholders cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Any person or entity purchasing or otherwise acquiring or holding any interest in shares of our capital stock shall be deemed to have notice of and consented to the forum provision in our Amended and Restated Certificate of Incorporation.

 

The choice-of-forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with the Company or its directors, officers or other employees, and may result in increased costs to a stockholder who has to bring a claim in a forum that is not convenient to the stockholder, which may discourage such lawsuits. Although under Section 115 of the DGCL, exclusive forum provisions may be included in a company’s certificate of incorporation, the enforceability of similar forum provisions in other companies’ certificates or incorporation or bylaws has been challenged in legal proceedings, and it is possible that a court could find these types of provisions to be inapplicable or unenforceable. If a court were to find the exclusive forum provision of our Amended and Restated Certificate of Incorporation and our Amended and Restated Bylaws inapplicable or unenforceable with respect to one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could materially and adversely affect our business, financial condition and results of operations and result in a diversion of the time and resources of our management and board of directors.

 

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This prospectus contains forward-looking statements. The forward-looking statements are contained principally in the sections entitled “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” These forward-looking statements involve a number of risks and uncertainties. Many of the following risks are, and will be, exacerbated by the COVID-19 pandemic and any worsening of the global business and economic environment as a result. We caution readers that any forward-looking statement is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking statement. These statements are based on current expectations of future events. Such statements include, but are not limited to, statements about future financial and operating results, plans, objectives, expectations and intentions, costs and expenses, interest rates, outcome of contingencies, financial condition, results of operations, liquidity, cost savings, objectives of management, business strategies, success of competing technologies, financing, potential growth and market opportunities, product candidates, clinical trial timing and plans, clinical and regulatory pathways for our development programs, the achievement of clinical and commercial milestones, the advancement of our technologies and our products, and other statements that are not historical facts.

 

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “possible” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this prospectus include, but are not limited to, statements about:

 

our ability to successfully develop our Human-on-a-Chip platform;
   
our ability to generate a profit;
   
our ability to effectively manage growth;
   
our ability to protect our intellectual property and continue to innovate;
   
our success in retaining or recruiting, or changes required in, our officers, key employees or directors following our offering;
   
the potential insufficiency of our disclosure controls and procedures to detect errors or acts of fraud;
   
the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
   
the success of competing devices or technologies that are or may become available;
   
our potential ability to obtain additional financing;
   
our ability to grow the business due to the uncertainty resulting from the recent COVID-19 pandemic or any future pandemic;
   
our ability to comply with complex and increasing regulations by state and federal authorities;
   
the impact of healthcare reform legislations;
   
our ability to have our securities listed on Nasdaq;
   
our public securities’ potential liquidity and trading;
   
the lack of an established market for our securities;
   
our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act;
   
our anticipated use of the proceeds from this offering; and
   
our financial performance following this offering.

 

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We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate, and financial trends that we believe may affect our business, prospects, financial condition and results of operations, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this prospectus and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this prospectus. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements in this prospectus represent our views as of the date of this prospectus. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this prospectus.

 

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.

 

All subsequent written or oral forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. We do not undertake any obligation to release publicly any revisions to these forward-looking statements to reflect events or circumstances after the date of this prospectus or to reflect the occurrence of unanticipated events, except as may be required under applicable law. If we do update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.

 

You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this prospectus by these cautionary statements.

 

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USE OF PROCEEDS

 

We estimate that the net proceeds from our issuance and sale of            shares of our common stock in this offering will be approximately $           million, based on an assumed initial public offering price of $            per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. If the underwriters exercise their option to purchase additional shares in full to cover overallotments, if any, we estimate that our net proceeds will be approximately $           million.

 

A $1.00 increase in the assumed initial public offering price of $          per share would increase the aggregate net proceeds to us from this offering by approximately $            million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase of 1.0 million shares in the number of shares offered by us would increase the net proceeds to us from this offering by approximately $            million, assuming that the assumed initial public offering price remains the same, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

 

The principal purposes of this offering are to obtain additional capital to support our operations, establish a public market for our common stock and facilitate our future access to the public capital markets. We currently anticipate that we will use the net proceeds from this offering, together with our existing resources, as follows:

 

  approximately $        to $        to enhance the fabrication of our Human-on-a-Chip system;
     
  approximately $        to $        to automate our system’s measurement processes in order to increase throughput and attain consistent quality;
     
  approximately $        to $        to invest in research and lab staff;
     
  approximately $        to $        to hire sales and marketing staff to target pharmaceutical companies and a broader set of commercial companies; and
     
  the remaining amounts to fund working capital and general corporate purposes.

 

We have assumed the holder of our $200,000 convertible note will elect to convert this note into shares of our common stock, but the holder may elect for the note to be repaid in cash.

 

We believe that our existing cash and cash equivalents, together with the net proceeds from this offering, will be sufficient to fund our operating expenses and capital expenditure requirements for at least the next 36 months. The amount and timing of our actual expenditures will depend upon numerous factors, and other factors described under “Risk Factors” in this prospectus, as well as the amount of cash used in our operations. We may find it necessary or advisable to use the net proceeds for other purposes, and we will have broad discretion in the use of the net proceeds from this offering and could spend the proceeds in ways that do not improve our results of operations or enhance the value of our stock. Pending their use, we plan to invest the net proceeds from this offering in money market funds short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.

 

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DIVIDEND POLICY

 

We have never declared or paid dividends on our common stock and we do not anticipate paying any cash dividends on our common stock in the foreseeable future. Payment of cash dividends, if any, in the future will be at the discretion of our board of directors and will depend on applicable law and then-existing conditions, including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors our board of directors may deem relevant. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business.

 

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CAPITALIZATION

 

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

 

On an actual basis;
   
On an as adjusted basis to give effect to our issuance and sale of        shares of our common stock in this offering at an assumed initial public offering price of $       per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions, estimated offering expenses payable.

 

The information below is illustrative only, and our capitalization following the closing of this offering will change based on the actual initial public offering price and other terms of this offering determined at pricing. You should read the information in this table, together with our financial statements and the related notes appearing elsewhere in this prospectus and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” that are included elsewhere in this prospectus by us.

 

   As of March 31, 2022  
   Actual   As Adjusted 
Cash and cash equivalents  $ 282,745    $             
Long-term liabilities    2,775,484       
Operating lease liability – current portion   

180,932

      
Notes payable and finance lease obligations – current portion    618,234       
Notes payable – related party – current portion    74,025       
Stockholders’ equity:          
Common stock, $0.0001 par value; 40,000,000 authorized shares, 9,133,165 issued and outstanding, actual and           issued and outstanding, as adjusted    913       
Additional paid-in capital    1,034,576       
Accumulated deficit    (1,420,692 )      
Total stockholders’ equity (deficit)     (385,203 )      
Total capitalization  $ 3,546,217    $ 

 

Each $1.00 increase in the assumed initial public offering price of  $       per share, would increase our cash, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $      million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. The information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.

 

The number of shares of our common stock to be outstanding after this offering is based on 9,133,165 shares of common stock outstanding as of March 31, 2022 and excludes the following:

 

281,250 shares of common stock granted to employees and directors as restricted stock awards vesting over five years;
   
1,425,700 shares of common stock reserved for future issuance under our Omnibus Incentive Plan;
   
       shares of common stock issuable upon the exercise of the Representative’s Warrants;
   
       shares of common stock issuable upon the conversion of convertible notes; and
   
Up to 30,000 shares of common stock issuable to the University of Central Florida Research Foundation pursuant to anti-dilution rights.

 

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DILUTION

 

If you invest in our common stock in this offering, your ownership interest will be diluted immediately to the extent of the difference between the initial public offering price per share of our common stock and the as adjusted net tangible book value per share of our common stock immediately after this offering.

 

Our historical net tangible book value (deficit) as of March 31, 2022 was $      , or $       per share of our common stock. Our historical net tangible book value (deficit) is the amount of our total tangible assets less our total liabilities. Historical net tangible book value per share represents historical net tangible book value (deficit) divided by the number of shares of our common stock outstanding as of March 31, 2022.

 

After giving effect to our issuance and sale of        shares of common stock in this offering at an assumed initial public offering price of $       per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting underwriting discounts and commissions, estimated offering expenses payable by us, the as adjusted net tangible book value as of March 31, 2022 would have been approximately $       million, or approximately $        per share. This represents an immediate increase in as adjusted net tangible book value per share of  $       to our existing stockholders and an immediate dilution in as adjusted net tangible book value per share of approximately $       to new investors purchasing common stock in this offering. Dilution per share to new investors purchasing common stock in this offering is determined by subtracting as adjusted net tangible book value per share after this offering from the assumed initial public offering price per share paid by new investors.

 

The following table illustrates this dilution on a per share basis to new investors:

 

Assumed public offering price per share       $  
Historical net tangible book value per share as of March 31, 2022   $       
As adjusted net tangible book value per share after giving effect to this offering  $       
Dilution in as adjusted net tangible book value per share to new investors participating in this offering       $  

 

Each $1.00 increase in the assumed initial public offering price of $       per share would increase the net tangible book value per share after this offering by $       per share and the dilution to new investors purchasing common stock in this offering by $       per share, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

 

If the underwriters exercise their option in full to purchase an additional              shares of common stock in this offering, the as adjusted net tangible book value per share after the offering would be $            per share, the increase in the net tangible book value per share to existing stockholders would be $               per share and the dilution to new investors purchasing our common stock in this offering would be $            per share.

 

The number of shares of common stock to be outstanding after this offering is based on the number of shares of common stock outstanding as of March 31, 2022, and excludes:

 

281,250 shares of common stock granted to employees and directors as restricted stock awards vesting over five years;
   
1,425,700 shares of common stock reserved for future issuance under our Omnibus Incentive Plan;
   
        shares of common stock issuable upon the exercise of the Representative’s Warrants;
   
        shares of common stock issuable upon the conversion of convertible notes; and
   
Up to 30,000 shares of common stock issuable to the University of Central Florida Research Foundation pursuant to anti-dilution rights.

 

To the extent that outstanding exercisable warrants are exercised, you may experience further dilution. If all outstanding exercisable warrants with exercise prices below $       per share were exercised, our as adjusted net tangible book value as of March 31, 2022 (calculated on the basis of the assumptions set forth above) would have been approximately $       million, or approximately $       per share, causing immediate dilution of $       per share to new investors purchasing shares in this offering.

 

In addition, we may choose to raise additional capital due to market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital by issuing equity securities or convertible debt, your ownership will be further diluted.

 

After completion of this offering, our existing stockholders would own approximately          % and our new investors would own approximately           % of the total number of shares of our common stock outstanding after this offering.

 

   Shares Purchased   Total Consideration     
   Number   Percent   Amount   Percent   Per Share 
                     
Existing stockholders       %  $    %  $ 
New investors              %  $    %  $ 
                                                  

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS

 

The following discussion and analysis of financial condition and results of operations should be read in conjunction with our audited financial statements, and the related notes and other financial information included elsewhere in this prospectus. You should carefully read the “Risk Factors” section of this prospectus to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements.

 

Overview

 

Hesperos, Inc., operating as a CRO, has developed a disruptive technology that provides safety and efficacy testing of chemicals and novel therapeutics for the pharmaceutical, cosmetic, and food industries for drug discovery and development using its Human-on-a-Chip® multi-organ, microphysiological system. We are a socially-conscious company that uses our non-invasive, serum-free, multi-organ chip platform (Human-on-a-Chip) systems to provide pre-clinical analytical services with the goal of accelerating drug discovery and general toxicology testing to help reduce the use of animal testing. Our systems mimic the process of initial patient evaluation during a clinical trial, where functional human in vitro tissues would be evaluated in the same manner as a human undergoes medical testing to determine baseline performance metrics. Our services allow research teams, including teams at pharmaceutical companies, to leverage our Human-on-a-Chip systems to determine initially how drug compounds and drug combinations will respond in the human body for both efficacy and off-target toxicity. Our services can provide guidance on the choice of which drug to take into clinical trials without the use of costly and time-consuming animal testing and as models for rare diseases that do not have animal models.

 

Although the majority of our revenue has been derived from SBIR grants from the NIH, we are experiencing increasing revenues from pharmaceutical and cosmetic industry clients. As of March 31, 2022, we have received approximately $17.5 million in funding from SBIR grants from the NIH, with approximately an additional $7.4 million available for use through 2024, subject to availability of funds and satisfactory progress of each project as determined by the NIH.

 

Impact of COVID-19 Pandemic

 

The COVID-19 pandemic created delays in our research and development activities as well as disruptions in our supply chain for necessary components of our Human-On-a-Chip systems such as computer chips, helium, cell culture supplies and certain types of live cells. Such delays impacted our business by delaying the completion of projects and receipt of cash flow related to the completion of such projects. For example, certain materials, such as live cells, necessary to complete active projects have been difficult to acquire due to disruptions in the global supply chain. Additionally, customer receivables and internal operations have been delayed with respect to completed and active contracted work due to personnel absence as a result of exposure to the virus or the need to care for dependents that may have been exposed. Restricted cash flow as a result of delays to our projects has caused us to suspend efforts to automate certain of our processes. Further delays that affect our ability to access capital may cause us to suspend operations and would have a negative impact on our ability to generate revenue. The extent to which the COVID-19 global pandemic impacts our future business, growth prospects and financial condition will depend on future developments, which are highly uncertain and are difficult to predict. These developments include, but are not limited to, the duration and spread of the outbreak, its severity, the actions to contain the virus or address its impact, U.S. and foreign government actions to respond to the reduction in global economic activity, and how quickly and to what extent normal economic and operating conditions can resume.

 

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Results of Operations

 

Comparison of the three months ended March 31, 2022 to the three months ended March 31, 2021

 

Our financial results for the three months ended March 31, 2022 are summarized as follows in comparison to the three months ended March 31, 2021:

 

    March 31,     March 31,  
    2022     2021  
REVENUES                
Grant revenue   $ 885,444     $ 988,684  
Commercial revenue     217,737       197,746  
Total Revenues     1,103,181       1,186,430  
                 
COST OF REVENUES                
Cost of revenues – grants (including related party costs of $149,765 and $136,762, respectively)     634,145       686,829  
Cost of revenues – commercial contracts     205,809       121,551  
Total Cost of Revenues     839,954       808,380  
                 
Gross Profit     263,227       378,050  
                 
Operating Expenses                
General and administrative (including related party costs of $59,642 and $3,856, respectively)     588,448       406,723  
Total Operating Expenses     588,448       406,723  
                 
Loss from Operations     (325,221 )     (28,673 )
                 
Other Income (Expense)                
Other income     247       2,134  
Interest expense     (22,958 )     (31,621 )
Total Other Expense, Net     (22,711 )     (29,487 )
                 
Net Loss   $ (347,932 )   $ (58,160 )
                 
Weighted average common shares outstanding:                
Basic and Diluted     9,125,699       8,948,035  
                 
Loss per common share:                
Basic and Diluted   $ (0.04 )   $ (0.01 )

 

Revenues

 

Our revenues during the three months ended March 31, 2022 were $1,103,181, as compared to revenues of $1,186,430 during the three months ended March 31, 2021, a decrease of $83,249, or 7%, due to a reduction in reimbursable grant revenues as the revenue from certain grants could not be recognized due to the reduction in expenses in the current period compared to the same period in the prior year. The impact of the reduction in grant revenues was partially offset by an increase in commercial revenues.

 

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Grant Revenue

 

During the three months ended March 31, 2022 and 2021, revenues included grant revenue of $885,444 and $988,684, respectively, a decrease of $103,240 or 10%. During the three months ended March 31, 2022 and 2021, we recognized $706,179 and $827,640, respectively, as revenue in relation to the grants received from NIH.

 

Commercial Revenue

 

During the three months ended March 31, 2022 and 2021, revenues included commercial revenue of $217,737 and $197,746, respectively, an increase of $19,991 or 10%. During the three months ended March 31, 2022, we continued to diversify its revenues by allocating more resources towards commercial contracts, resulting in the increase in commercial revenue and decrease in grant revenue.

 

Cost of Revenues

 

Our cost of revenues for the three months ended March 31, 2022 were $839,954 as compared to $808,380 during the three months ended March 31, 2021. The increase of $31,574, or 4%, was due to commercial contracts being development projects which required building new models, resulting in an increase in cost of revenues.

 

Cost of Revenues – Grants

 

Our grant cost of revenues for the three months ended March 31, 2022 were $634,145 as compared to $686,829 during the three months ended March 31, 2021. The decrease of $52,684 or 8% is directly attributed to allocating more resources towards commercial contracts to diversify our revenue.

 

Cost of Revenues – Commercial Contracts

 

Our commercial cost of revenues for the three months ended March 31, 2022 were $205,809 as compared to $121,551 during the three months ended March 31, 2021. The increase of $84,258 or 69% is due to us allocating more resources to commercial contracts, and due to commercial contracts being development projects which required building new models, resulting in an increase in cost of revenues.

 

Gross Profit

 

Gross profit for the three months ended March 31, 2022 was $263,227 as compared to gross profit of $378,050 for the three months ended March 31, 2021. The decrease of $114,823, or 30%, was due to reduced grant revenue as indirect costs associated with the reduced materials expense noted above could not be reimbursed without the added expense. Additionally, as discussed above in Cost of Revenues – Commercial Contracts, the decrease of gross profit was caused by an increase in commercial contracts that were development projects during 2022 which resulted in a larger increase in costs compared to revenues as these projects required building new models. We expect gross profit to stabilize in future periods.

 

General and Administrative Expenses

 

General and administrative increased by $181,725, or 45%, from $406,723 for the three months ended March 31, 2022 to $588,448 for the three months ended March 31, 2021. The increase was primarily a result of increased accounting and legal expenses due to the preparation for an initial public offering, as well as increased compensation costs due to increased headcount.

 

Interest Expense and Other Income

 

We recognized interest expense of $22,958 during the three months ended March 31, 2022 and $31,621 during the three months ended March 31, 2021, representing a decrease of $8,663, or 27%, in interest expense for 2022. We recorded other income of $247 and $2,134 in the three months ended March 31, 2022 and 2021, respectively.

 

Net loss

 

Our net loss for the three months ended March 31, 2022 was $347,932 as compared to net loss of $58,610 for the three months ended March 31, 2021. The increase in net loss is a result of allocating more resources to commercial contracts which reduced grant revenues and increased cost of revenues associated with commercial contracts, as discussed above. Additionally, during the three months ended March 31, 2022, we saw an increase in professional fees as a result of our initial public offering and an increase in payroll expense to support growing operations, which included the hiring of a Chief Executive Officer.

 

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Results of Operations

 

Comparison of the year ended December 31, 2021 to the year ended December 31, 2020

 

Our financial results for the year ended December 31, 2021 are summarized as follows in comparison to the year ended December 31, 2020:

 

    December 31,     December 31,  
    2021     2020  
REVENUES                
Grant revenue   $ 4,363,010     $ 4,754,641  
Commercial revenue     834,360       487,735  
Total Revenues     5,197,370       5,242,376  
                 
Cost of Revenues     3,724,316       3,748,360  
                 
Gross Profit     1,473,054       1,494,016  
                 
Operating Expenses                
General and administrative     1,848,928       1,576,718  
Total Operating Expenses     1,848,928       1,576,718  
                 
Loss from Operations     (375,874 )     (82,702 )
                 
Other Income (Expense)                
Interest expense     (115,866 )     (114,804 )
Forgiveness of notes payable – PPP loan     -       244,800  
Other income     8,196       17,419  
Total Other Income (Expense), Net     (107,670 )     147,415  
                 
Net Income (Loss)   $ (483,544 )   $ 64,713  
                 
Weighted average common shares outstanding:                
Basic     9,011,393       8,933,016  
Diluted     9,011,393       9,070,039  
                 
Earnings per common share:                
Basic   $ (0.05 )   $ 0.01  
Diluted   $ (0.05 )   $ 0.01  

 

Revenues

 

Our revenues during the year ended December 31, 2021 were $5,197,370, as compared to revenues of $5,242,376 during the year ended December 31, 2020, a decrease of $45,006, or 1%, due to a reduction in reimbursable grant revenues as the revenue from certain grants could not be recognized due to the reduction in expenses in the current year. The impact of the reduction in grant revenues was partially offset by an increase in commercial revenues.

 

Grant Revenue

 

During the years ended December 31, 2021 and 2020, revenues included grant revenue of $4,363,010 and $4,754,641, respectively, a decrease of $391,631 or 8%. During the years ended December 31, 2021 and 2020, we recognized $3,615,387 and $4,224,254, respectively, as revenue in relation to the grants received from NIH.

 

Commercial Revenue

 

During the year ended December 31, 2021 and 2020, revenues included commercial revenue of $834,360 and $487,735, respectively, an increase of $346,625 or 71%. During the year ended December 31, 2021, we began to diversify its revenues by allocating more resources towards commercial contracts, resulting in the increase in commercial revenue and decrease in grant revenue.

 

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Cost of Revenues

 

Our cost of revenues for the year ended December 31, 2021 were $3,724,316 as compared to $3,748,360 during the year ended December 31, 2020. The decrease of $24,044, or 1%, was due to the reduction in materials required as our technology improved.

 

Gross Profit

 

Gross profit for the year ended December 31, 2021 was $1,473,054 as compared to gross profit of $1,494,016 for the year ended December 31, 2020. The decrease of $20,962, or 1%, was due to reduced grant revenue as indirect funds associated with the reduced materials expense noted above could not be reimbursed without the added expense. 

 

General and Administrative Expenses

 

General and administrative increased by $272,210, or 17%, from $1,576,718 for the year ended December 31, 2020 to $1,848,928 for the year ended December 31, 2021. The increase was primarily a result of an increase to payroll expenses as we increased the number of employees as we expanded operations in 2021.

 

Interest and Other Income

 

We recognized interest expense of $115,866 in 2021 and $114,804 in 2020, representing an increase of $1,062, or 1.0%, in interest expense for 2021. We recorded other income of $8,196 and $17,419 in the years ended December 31, 2021 and 2020, respectively. In 2020, we also recorded $244,800 of income in relation to the forgiveness of the PPP loan.

 

Net Income (Loss)

 

Our net loss for the year ended December 31, 2021 was $483,544 as compared to net income of $64,713 for the year ended December 31, 2020. During 2020, we reported net income due to the forgiveness of the PPP loan in the amount of $244,800.

  

Liquidity and Capital Resources

 

For the three months ended March 31, 2022, we were cash flow negative from our operating activities. As of March 31, 2022, we had an accumulated deficit of $1,420,692 and a working capital deficit of $860,319. Since inception, we have funded our operations primarily from NIH and other governmental grants, commercial revenues, and, to a lesser extent, through debt financings, including $610,000 provided by Dr. Hickman.

 

At March 31, 2022, December 31, 2021 and December 31, 2020, we had a working capital deficit as shown below:

 

   

March 31,

    December 31,     December 31,  
    2022     2021     2020  
Total Current Assets   $ 877,155     $ 1,295,720     $ 791,013  
Total Current Liabilities     1,737,474       1,701,264       1,425,330  
Working Capital (Deficiency)   $ (860,319 )   $ (405,544 )   $ (634,317 )

 

Included in our current liabilities are amounts totaling $347,394, $364,950 and $86,424 that are due to related parties at March 31, 2022, December 31, 2021 and December 31, 2020, respectively, which are due within our next operating cycle Also, included in our current liabilities is deferred revenue from commercial customers and government grants totaling $317,306, $414,823 and $277,178 at March 31, 2022, December 31, 2021 and December 31, 2020, respectively.

 

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Notes payable – related party

 

During 2019, we entered into a promissory note with Dr. Hickman under which we borrowed $150,000 at an annual interest rate of 4.00%. Monthly payments began in November 2021, with the promissory note maturing on October 31, 2024.

 

During 2020, we entered into a promissory note with Dr. Hickman under which we borrowed $80,000 at an annual interest rate of 3.00%. Monthly payments were to begin ninety days after issuance. The note was paid in monthly installments and was paid in full as of December 31, 2021.

 

During 2021, we entered into a promissory note with the Dr. Hickman under which we borrowed $200,000 at an interest rate of 3%. Monthly payments begin on June 1, 2022 and the promissory note is scheduled to be paid in full on December 31, 2026.

 

The related party notes’ obligation totaled $245,138, $358,597 and $219,771 as of March 31, 2022, December 31, 2021 and December 31, 2020, respectively.

 

Note payable – financed asset – equipment, net of deferred financing costs

 

In 2020, we financed the acquisition of certain research equipment with a third-party note. This note originally allowed us to borrow up to $130,975 in installments as equipment installation milestones are met. The note originally bore interest at 3.85% per annum, and payments were to begin upon completion of the final milestone with the maturity date being sixty months after the final milestone was to be complete. As of March 31, 2022 and December 31, 2021, we borrowed a total of $104,780 under this note. The loan obligation totaled $104,780 as of March 31, 2022 and December 31, 2021. As of December 31, 2020, we borrowed, and the loan obligation was, $35,698 under this note. For more information, see Note 12 to the condensed financial statements, Subsequent Events.

 

Finance leases obligations

 

We currently have finance lease obligations for research equipment with interest rates between 6.20% and 7.50%, per annum. Monthly payments range from $306 to $7,860. All leases have a term between three and six years. The finance leases obligations totaled $1,177,649, $1,233,498 and $1,491,592 as of March 31, 2022, December 31, 2021 and December 31, 2020, respectively. All finance lease obligations are guaranteed by Dr. James Hickman, our Chief Scientist and Board Chairman.

 

Convertible Promissory Note

 

On March 28, 2022, we issued a $200,000 convertible promissory note (the “Convertible Note”) to a third party (the “Holder”) in exchange for $200,000. The Convertible Note bears interest at 12%, per annum. All unpaid principal and accrued interest under the Convertible Note will be due and payable in full six months from issuance. In the event that we issue and sell shares of our common stock, par value $0.0001 per share, to the public in a firm-commitment underwritten public offering pursuant to an effective registration statement under the Act, resulting in at least $5,000,000 of aggregate proceeds, net of the underwriting discount and commissions, to us (a “Qualified Initial Public Offering”), then at the closing of such Qualified Initial Public Offering, the Holder may elect that either: (i) the we will pay Holder an amount equal to the sum of (a) all accrued and unpaid interest due on this Convertible Note and (b) the outstanding principal balance of this Convertible Note; or (ii) this Convertible Note will convert into that number of shares of common stock equal to the quotient obtained by dividing the outstanding principal balance and unpaid accrued interest under this Note as of the date of the closing of the Qualified Initial Public Offering by the amount equal to the public offering price per share in the Qualified Initial Public Offering multiplied by seventy percent (70%).

 

Economic Injury Disaster Loan

 

Entities negatively impacted by the coronavirus (“COVID-19”) pandemic were eligible to apply for loans sponsored by the United States Small Business Administration (“SBA”) Economic Injury Disaster Loan (“EIDL Loan”) program. On July 17, 2020, we received cash proceeds of $150,000 under this program. The proceeds can be used to fund payroll, healthcare benefits, rent and other qualifying expenses, and the loan is not subject to loan forgiveness provisions. The standard EIDL Loan repayment terms include interest accruing at 3.75% per annum effective July 17, 2020; the payment schedule contains a one-year deferral period on initial principal and interest payments; the loan term is thirty years; and there is no prepayment penalty or fees. We pledged all of our assets as collateral for the loan. On July 22, 2021, the EIDL amount was increased to $500,000. Installment payments increased to $2,526 per month. There were no additional amendments to the EIDL. As of both March 31, 2022 and December 31, 2021, the amounts outstanding totaled $500,000, respectively and is classified as part of notes payable and finance lease obligations – current portion and net of current portion on the condensed balance sheets. On January 6, 2021, the SBA announced a one-year extension of the deferral period for loans that commenced in 2020 delaying payments of principal and interest to July 2022.

 

Paycheck Protection Program

 

On March 16, 2021, we entered into a loan agreement with a financial institution for a loan of $85,800 pursuant to the Paycheck Protection Program (the “PPP”) under the Coronavirus Aid, Relief, and Economic Security Act enacted on March 27, 2020 (the “CARES Act”). This loan is evidenced by a promissory note dated March 16, 2021 and matures two years from the disbursement date. This loan bears interest at a rate of 1.00% per annum, with the first six months of interest deferred. Principal and interest are payable monthly commencing one year after the disbursement date and may be prepaid by us at any time prior to maturity with no prepayment penalties. This loan contains customary events of default relating to, among other things, payment defaults or breaches of the terms of the loan. Upon the occurrence of an event of default, the lender may require immediate repayment of all amounts outstanding under the note. The principal and interest of the loan are repayable in sixty (60) monthly equal installments of $1,485 each commencing on June 16, 2022. Interest accrued in the first six months is included in the monthly installments. Installments must be paid on the 24th day of each month. We initially determined that the PPP loan had not met forgiveness criteria. As of both March 31, 2022 and December 31, 2021, the amounts outstanding totaled $85,800, and is classified as part of notes payable and finance lease obligations – current portion and net of current portion on the condensed balance sheets. In July 2022, we received notice from the SBA that the PPP loan was forgiven on July 1, 2022.

 

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Cash Flows

 

The following table sets forth the primary sources and uses of cash and cash equivalents for the three months ended March 31, 2022 and 2021.

 

    For the Three Months Ended March 31,  
    2022     2021  
Cash proceeds provided by (used in):                
Operating activities   $ (61,921 )   $ 16,276  
Investing activities     -       (15,636 )
Financing activities     (3,006 )     (44,579 )
Net decrease in cash and cash equivalents   $ (64,927 )   $ (43,939 )

 

Net cash (used in) provided by operating activities

 

Net cash used in operating activities was $61,921 for the three months ended March 31, 2022 and Net cash provided by operating activities was $16,276 for the three months ended March 31, 2021. Net cash used in operating activities of $61,921 primarily consists of a net loss of $347,932, offset by non-cash expenses of depreciation and amortization of $116,455, stock-based compensation of $8,949, and non-cash lease expense of $3,646, as well as working capital items in the amount of $156,961, principally related to the decrease in accounts receivable of $350,633 offset by the decrease in accounts payable – related parties of $20,056, decrease in deferred revenue of $97,517, the decrease in accrued expenses of $60,750, and the decrease in payroll liabilities and other current liabilities of $20,295, We anticipate our on-going general and administrative costs will result in negative cash flows from operating activities for the foreseeable future.

 

Net cash used in investing activities

 

Net cash used in investing activities was $0 and $15,636 for the three months ended March 31, 2022 and 2021, respectively, as a result of the purchase of property and equipment.

 

Net cash used in financing activities

 

Net cash used in financing activities was $3,006 and $44,579 for the three months ended March 31, 2022 and 2021, respectively. The $3,006 used in financing activities in 2022 consists of the repayment of notes, finance obligations and related party notes in the amount of $203,006, offset by proceeds from notes payable of $200,000. The $44,579 used in financing activities in 2021 consists of proceeds from notes payable and related party notes of $85,800, offset by repayments of notes payable, related party notes and finance lease obligations of 130,379.

 

The following table sets forth the primary sources and uses of cash and cash equivalents for the years ended December 31, 2021 and 2020.

 

    For the Years Ended
December 31,
 
    2021     2020  
Cash proceeds provided by (used in):                
Operating activities   $ 186,988     $ 182,932  
Investing activities     (37,036 )     (6,211 )
Financing activities     84,616       (306,915 )
Net increase (decrease) in cash and cash equivalents   $ 234,568     $ (130,194 )

 

Net cash provided by operating activities

 

Net cash provided by operating activities was approximately $186,988 and $182,932 for the years ended December 31, 2021 and 2020, respectively. For the year ended December 31, 2021, net cash provided by operating activities of $186,988 primarily consists of a net loss of $483,544, offset by non-cash expenses of depreciation and amortization of $456,978, stock-based compensation of $43,439, and non-cash lease expense of $16,866, as well as working capital items in the amount of $153,249, principally related to the increase in accounts payable – related parties of $278,526, increase in deferred revenue of $137,645, the decrease in other assets of $75,000, and the increase in accrued expenses of $44,083, offset by the increase in accounts receivable of $289,180 and decrease in accounts payable of $136,613. We anticipate our on-going general and administrative costs will result in negative cash flows from operating activities for the foreseeable future.

 

For the year ended December 31, 2020, net cash provided by operating activities of $182,932 primarily consisted of net income of $64,713, offset by non-cash expenses of depreciation and amortization of $439,825, stock-based compensation of $39,036, and non-cash lease expense of $23,665, as well as a net decrease in working capital items in the amount of $212,395, principally related to the increase in accounts payable of $272,102, increase in deferred revenue of $84,471, the decrease in other assets of $2,000, and the increase in accrued expenses of $12,473, offset by the increase in accounts receivable of $171,912 and decrease in accounts payable – related parties of $520,242.

 

Net cash used in investing activities

 

Net cash used in investing activities was $37,036 and $6,211 for the years ended December 31, 2021 and 2020 as a result of the purchase of property and equipment in both years.

 

Net cash provided by (used in) financing activities

 

Net cash provided by financing activities was $84,616 for the year ended December 31, 2021, compared to net cash used by financing activities of $306,915 for the year ended and December 31, 2020. The $84,616 provided by financing activities in 2021 consists of proceeds from notes payable and related party notes of $635,800, offset by the repayment of notes payable, finance obligations and related party notes in the amount of $551,184. The $306,915 used in financing activities in 2020 consists of repayments of notes payable, related party notes and finance lease obligations totaling $536,915, partially offset by proceeds from notes and related party notes totaling $230,000.

 

Critical Accounting Policies and Estimates

 

Critical Accounting Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results and outcomes may differ from management’s estimates and assumptions. Included in these estimates are assumptions used to estimate collection of accounts receivable, fair value of intangible assets, valuation of lease liabilities and related right of use assets, deferred income tax asset valuation allowances, and valuation of stock based compensation expense.

 

Long-Lived Assets

 

Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the book value of the asset may not be recoverable. We periodically evaluate whether events and circumstances have occurred that indicate possible impairment. When impairment indicators exist, we estimate the future undiscounted net cash flows of the related asset or asset group over the remaining life of the asset in measuring whether or not the asset values are recoverable.

 

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Stock-based Compensation

 

Our share-based compensation program grant awards include restricted stock awards. The fair value of restricted stock awards is based on the fair value of our common stock on the date of the grant. The fair value of the stock-based awards are then expensed over the requisite service period, generally the vesting period, for each award.

 

We have periodically granted restricted stock awards to consultants for services, pursuant to our stock plans at the fair market value on the respective dates of grant. Should we terminate any of our consulting agreements, the unvested awards underlying the agreements would be cancelled. For awards granted to consultants and non-employees, compensation expense is recognized over the vesting period of the awards, which is generally the period services are rendered by such consultants and non-employees.

 

Revenue Recognition

 

Our revenue is expected to be generated primarily from the sale of research services, including revenue from our Human-on-a-Chip systems and research grant revenue.

 

We recognize revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, we recognize revenue when control of our services is transferred to our customers in an amount that reflects the consideration we expect to receive from our customers in exchange for those services. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, we perform a five-step process. This process involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when (or as) the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. We only apply the five-step process to contracts when it is probable that the entity will collect consideration it expects to be entitled to in exchange for the goods or services it transfers to the customer.

 

We recognize revenue when (i) evidence of an arrangement exists, (ii) fees are fixed and determinable, (iii) services have been delivered, and (iv) collectability is reasonably assured. We currently generate revenue primarily from government grants and commercial contracts. Government grants are agreements that provide us with payments for certain types of expenditures in return for research and development activities over a contractually defined period. We recognize revenue when performance obligations related to respective revenue streams are met. For Grant Revenue, we consider the performance obligation met when the grant related expenses are incurred, or supplies and materials are received, provided that the applicable conditions under the government grants have been met. Revenues and related expenses are presented gross in the statements of operations as we determined that it is the primary obligor under the arrangements relative to the research and development services performed by us as lead technical expert. These revenues are not viewed as “incidental” or “peripheral.” Grant revenue for the three months ended March 31, 2022 and 2021 were for research and development related activities that provide for payments for reimbursed costs, which may include overhead and general and administrative costs as well as a related profit margin. For commercial revenue from Contract Research Services, we consider the performance obligation met when the contractual obligation and / or statement of work has been satisfied. Costs of the contract’s revenue are recorded as cost of revenues in our statements of operations.

 

Grant Revenue

 

Our grant revenues are derived from research programs by various departments of the National Institute of Health (“NIH”).

 

Grants awarded to us for research and development by government entities are outside the scope of the contracts with customers and contributions guidance. This is because these granting entities are not considered to be customers and are not receiving reciprocal value for their grant support provided to us. These grants provide us with payments for certain types of expenditures in return for research and development activities over a contractually defined period.

 

We recognize NIH grant revenue as reimbursable grant costs that are incurred up to pre-approved award limits within the budget period. The costs associated with these reimbursements are reflected as a component of cost of revenue expense in the accompanying statements of operations.

 

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Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements as defined in the rules and regulations of the SEC. We do not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or for any other contractually narrow or limited purpose.

 

Related Party Transactions

 

The related party notes’ obligation totaled $245,138 and $358,597 as of March 31, 2022 and December 31, 2021, respectively.

 

During 2019, we entered into a promissory note with Dr. Hickman under which we borrowed $150,000 at an annual interest rate of 4.00%. Monthly payments began in November 2021, with the promissory note maturing on October 31, 2024.

 

During 2020, we entered into a promissory note with Dr. Hickman under which we borrowed $80,000 at an annual interest rate of 3.00%. Monthly payments were to begin ninety days after issuance. The note was paid in monthly installments and was paid in full as of December 31, 2021.

 

During 2021, we entered into a promissory note with the Dr. Hickman under which we borrowed $200,000 at an interest rate of 3%. Monthly payments begin on June 1, 2022 and the promissory note is scheduled to be paid in full on December 31, 2026. 

 

Dr. Hickman is also a professor at the Nanoscience Technology Center at the University of Central Florida (“UCF”), and Dr. Shuler is a professor at Meinig School of Biomedical Engineering at Cornell. UCF owns 281,250 of our common stock, received in exchange for a number of patent licensing rights granted by UCF for Dr. Hickman’s inventions. Additionally, we have several sub-contracts with UCF, as well as Cornell, for research and developments services provided by such universities to fulfill our obligations under the NIH grants. During the three months ended March 31, 2022 and 2021, we incurred expenses of $0 and $50,000, respectively, with regards to sub-contracts from Cornell, and $149,765 and $86,762, respectively, with regards to subcontracts from UCF. These expenses are included in cost of revenues on the condensed statements of operations. Additionally, we incurred operating expenses from UCF of $59,642 and $3,856 included in general and administrative expenses on the condensed statements of operations. As of March 31, 2022 and December 31, 2021, we owed Cornell $2,500 and $50,000, respectively, and owed UCF $344,894 and $314,950, respectively. These payables are included in accounts payable – related parties on the condensed balance sheets.

 

JOBS Act

 

Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of new or revised accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, we will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

 

For as long as we remain an emerging growth company under the recently-enacted JOBS Act, we will, among other things:

 

  be permitted to have only two years of audited financial statements and only two years of related selected financial data and management’s discussion and analysis of financial condition and results of operations disclosure;
     
  be entitled to rely on an exemption from compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act;
     
  be entitled to reduced disclosure obligations about executive compensation arrangements in our periodic reports, registration statements and proxy statements; and
     
  be exempt from the requirements to seek non-binding advisory votes on executive compensation or golden parachute arrangements.

 

Although we are still evaluating the JOBS Act, we currently intend to take advantage of some or all of the reduced regulatory and reporting requirements that will be available to us so long as we qualify as an “emerging growth company.” Among other things, this means that our independent registered public accounting firm will not be required to provide an attestation report on the effectiveness of our internal control over financial reporting so long as we qualify as an emerging growth company, which may increase the risk that weaknesses or deficiencies in our internal control over financial reporting go undetected.

 

Likewise, so long as we qualify as an emerging growth company, we may elect not to provide certain information, including certain financial information and certain information regarding compensation of our executive officers, that we would otherwise have been required to provide in filings we make with the SEC, which may make it more difficult for investors and securities analysts to evaluate our company. As a result, investor confidence in our company and the market price of our common stock may be materially and adversely affected.

 

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Recently Issued Accounting Pronouncements

 

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (“ASU 2016-13”), which requires the measurement of expected credit losses for financial instruments carried at amortized cost, such as accounts receivable, held at the reporting date based on historical experience, current conditions and reasonable forecasts. The main objective of this ASU is to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financing Instruments—Credit Losses. ASU 2016-13 is effective for fiscal years beginning after December 15, 2019. On November 15, 2019, the FASB delayed the effective date of FASB ASC Topic 326 for certain small public companies and other private companies. As amended, the effective date of ASC Topic 326 was delayed until fiscal years beginning after December 15, 2022 for SEC filers that are eligible to be smaller reporting companies under the SEC’s definition. The Company does not currently believe the adoption of this standard will have a significant impact on its financial statements, given its history of minimal bad debt expense relating to trade accounts receivable.

 

In August 2020, the FASB issued Accounting Standards Update (“ASU”) No. 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and it simplifies the diluted earnings per share calculation in certain areas. The ASU is effective for fiscal years beginning after December 15, 2021. The Company adopted ASU 2020-06 on January 1, 2022, which did not have a material impact on the financial statements.

 

In October 2021, the FASB issued ASU 2021-07—Compensation—Stock Compensation (Topic 718): Determining the Current Price of an Underlying Share for Equity-Classified Share-Based Awards. The measurement objective in Topic 718 for share-based awards is fair value based, and the current price input is measured at fair value. This input is used in determining an award’s fair value. The practical expedient in this Update allows a non-public entity to determine the current price of a share underlying an equity classified share-based award using the reasonable application of a reasonable valuation method. The practical expedient in this Update is effective prospectively for all qualifying awards granted or modified during fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. Early application, including application in an interim period, is permitted for financial statements that have not yet been issued or made available for issuance as of October 25, 2021. The Company is currently evaluating the impact of the adoption of this update on its financial statements.

 

In November 2021, the Financial Accounting Standards Board issued ASU 2021-10, “Government Assistance (Topic 832), Disclosures by Business Entities about Government Assistance,” which requires annual disclosures that increase the transparency of transactions involving government assistance, including (1) the types of transactions, (2) the accounting for those transactions, and (3) the effect of those transactions on an entity’s financial statements. The amendments in this update are effective for all entities within the ASU’s scope for financial statements issued for annual periods beginning after December 15, 2021. This ASU will be effective for the Company in the first quarter of fiscal year 2023. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of this update on its financial statements.

 

Except as noted above, the guidance issued by the FASB during the current year is not expected to have a material effect on the company’s financial statements. A variety of proposed or otherwise potential accounting standards are currently under consideration by standard setting organizations and regulatory agencies. Because of the tentative and preliminary nature of such proposed standards, management has not yet determined the effect if any that the implementation of such proposed standards would have on the company’s financial statements.

 

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BUSINESS

 

Overview

 

Hesperos, Inc., operating as a CRO, has developed a disruptive technology that provides safety and efficacy testing of chemicals and novel therapeutics for the pharmaceutical, cosmetic, and food industries for drug discovery and development using its Human-on-a-Chip® multi-organ, microphysiological system. Our systems mimic the process of initial patient evaluation during a clinical trial, where functional human in vitro tissues would be evaluated in the same manner as a human undergoes medical testing to determine baseline performance metrics. Our services allow research teams, including teams at pharmaceutical companies, to leverage our Human-on-a-Chip systems to determine initially how drug compounds and drug combinations will respond in the human body for both efficacy and off-target toxicity. Our services can provide guidance on the choice of which drug to take into clinical trials without the use of costly and time-consuming animal testing and as models for rare diseases that do not have animal models.

 

The pre-clinical testing our Human-on-a-Chip system provides is customarily carried out through animal testing. Our system uses an in vitro device, in which human organ mimics composed of cells obtained or derived from various human organs and tissues are embedded and maintained in culture conditions (akin to growing cells in a sophisticated petri dish). Our systems are unique in that we have functional readouts that utilize electrical, force and barrier integrity measurements that monitor organ health non-invasively without cell death to mimic clinical function observations such as walking, talking, cardiac function and other non-invasive clinical observations. The ability to link all these organ mimics together in the same recirculating serum-free media (a blood substitute) for up to 28 days with circulated immune cells establishes a platform where diseases such as diabetes, cancer, neurological diseases and a host of rare diseases can be evaluated. We can also provide information on drug-drug interactions for both efficacy and toxicity that is clinically relevant, especially for cancer treatment.

 

We believe our Human-on-a-Chip systems provide a compelling value proposition to pharmaceutical companies and other entities, including the cosmetic industry. We believe that our technologies benefit drug discovery in human disease areas that are difficult to address using current methodologies, help eliminate animal testing, accelerate preclinical drug discovery and development, reduce risk of clinical failure, predict with greater degrees of confidence and ultimately, significantly reduce the cost of discovering new drugs and especially for repurposing existing drugs. These platforms are uniquely positioned to also tackle development of drugs to treat rare diseases as there are over 7,000 rare diseases but approximately 95 percent have no treatment due to a lack of animal models. Our systems can be utilized to create phenotypic models for efficacy for the rare disease CIPD1 which led to an IND that the FDA used to allow a Phase II clinical trial to proceed (clinical trial NCT04658472 available at https://clinicaltrials.gov/ct2/show/NCT04658472). This IND utilized safety data from an ongoing clinical trial for another rare disease combined with our efficacy data, at substantially reduced cost and time compared to standard protocols. This creates a significant opportunity to work with large and small pharmaceutical companies to repurpose drugs for other rare disease when animal models do not exist.

 

Although the majority of our revenue has been derived from SBIR grants from the NIH, we are experiencing increasing revenues from pharmaceutical and cosmetic industry clients. As of March 31, 2022, we have received approximately $17.5 million in funding from SBIR grants from the NIH, with approximately an additional $7.4 million available for use through 2024, subject to availability of funds and satisfactory progress of each project as determined by the NIH.

 

Market Opportunity

 

Drug discovery is complex, capital intensive and is prone to high failure rates. Many current pre-clinical and clinical testing methodologies fail to identify drug liabilities early and cheaply in the drug development process. According to Nature Reviews Drug Discovery, brain and heart toxicity cause 60% of safety-related drug clinical trial failures as a result of the inadequacy of non-human animal models in preclinical toxicology testing (Nature Reviews Drug Discovery, 13, 419–431 (2014)). In addition, according to a report published by independent research company Visiongain, “Cell-based Assay World Industry and Market Prospects (2016-2026),” persistently high drug failure rates and a trend toward animal-free testing for preclinical drug screening are predicted to create a nearly $12 billion market for cell-based models by 2026.

 

It takes many years and very large financial investments to develop a new drug. Although there are many factors that contribute to this inefficiency, we believe one major problem is low correlation in many cases between animal models and human response. In particular, the translation of pre-clinical studies based on animal testing often fails to inform successful clinical trials. Nine out of ten drugs that appear safe and effective in animals subsequently fail in human trials.

 

We are not aware of any other platform that has created multi-organ systems to predict pharmacokinetics and pharmacodynamics which we now offer as a service.2 Of the over 7,000 known rare diseases, approximately 95 percent have no treatment because of a lack of animal models. Our systems were utilized to create phenotypic models for efficacy for the rare disease CIPD3 which led to an IND that the FDA used to allow a Phase II clinical trial to proceed (clinical trial NCT04658472 available at https://clinicaltrials.gov/ct2/show/NCT04658472). This IND utilized safety data from an ongoing clinical trial for another rare disease combined with our efficacy data, at substantially reduced cost and time compared to standard protocols. This creates a significant opportunity to work with large and small pharmaceutical companies to repurpose drugs for other rare disease when animal models do not exist. However, there is no assurance that the FDA will give similar treatment to future studies that use our systems.

 

To date, we have worked with 15 clients, 14 of which operate within the pharmaceutical industry and one of which operates within the cosmetic industry. Currently, we work with 6 clients in the pharmaceutical industry. Services provided to these clients include efficacy studies, toxicology studies, and model development. We have worked with one client to provide efficacy data in connection with their investigational new drug (“IND”) application which the FDA allowed to proceed to a Phase II clinical trial application in December 2020 and which was authorized and began recruiting patients in April of 2021. However, there is no assurance that the FDA will give similar treatment to future studies that use our systems.

 

 

1 Rumsey et al.,Classical Complement Pathway Inhibition in a “Human-On-A-Chip” Model of Autoimmune Demyelinating Neuropathies, Advanced Therapeutics, 2022:2200030, (2022). 

2 McAleer et al., On the potential of in vitro organ-chip models to define temporal pharmacokinetic-pharmacodynamic relationships, Scientific Reports 9:9619 (2019).

3 Rumsey et al, Classical Complement Pathway Inhibition in a “Human-On-A-Chip” Model of Autoimmune Demyelinating Neuropathies, Advanced Therapeutics, 2022:2200030, (2022).

 

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Our Solution for Drug Development

 

Our Human-on-a-Chip system is designed to enable rapid and efficient screening of drug candidates that would otherwise fail later in the drug development process, which can save a pharmaceutical company years and millions of dollars by identifying preclinical failures early in the development process. Our systems mimic the process of initial patient evaluation during a clinical trial, where functional human in vitro tissues would be evaluated in the same manner as a human undergoes medical testing to determine baseline performance metrics. Specific screens for heart rate, respiration, basic cognitive function, reflex tests on muscle and nerve, elimination, and chemical screens for liver, kidney and hematopoietic function are reproduced for integration in our unique pumpless platform. If anything abnormal is observed in these simple, yet high information functional evaluations, additional biomarkers are then evaluated much like a blood test administered to a patient. If a chip ceases to function, a “post mortem” examination of the tissue is completed. This approach enables the platform to be utilized not only for acute but also chronic evaluation of drugs non-invasively for periods of up to several months at a time. The number and frequency of biomarker assays would be reduced due to the use of the functional readouts which mimic heart rate, muscle function, barrier integrity and brain activities, thus reducing costs and increasing efficiency during pre-clinical evaluations. Because of our more holistic approach to the process of pre-clinical evaluation, more subtle effects, not just cell death, can be detected in our kind of system. When new drugs advance from preclinical testing to clinical trials, the ability to view results in real time and correlate the in vivo results to clinical predictions utilizing our pharmacokinetic/pharmacodynamics simulation is valuable because it enhances a drug developer’s ability to iterate without the time and cost associated with more traditional methods.

 

We have successfully completed projects with a number of pharmaceutical companies where the results are detailed in high impact journals, including Roche Pharmaceuticals, for both efficacy and off-target toxicity determination for cancer drugs;4 AstraZeneca, for developing a pharmacokinetic (PK)/pharmacodynamics (PD) model of our heart-liver system that predicted in vivo outcomes for drugs in guinea pigs and dogs as well as resolved issues for one of the drugs that passed their standard preclinical screen but failed in an animal model;5 and Sanofi, for providing efficacy data for their investigational new drug application for the rare diseases chronic inflammatory demyelinating polyneuropathy (CIDP), which the FDA allowed to proceed to a Phase II clinical trial application (NCT04658472) in December 2020, and where the clinical trial was authorized and began recruiting patients in April of 2021 where the data from our system is described in a recently-published peer-reviewed article.6 This IND utilized safety data from an ongoing clinical trial for another rare disease combined with our efficacy data, at substantially reduced cost and time compared to standard protocols. This creates a significant opportunity to work with large and small pharmaceutical companies to repurpose drugs for other rare disease when animal models do not exist.

 

Human-on-a-Chip Systems

 

Our Human-on-a-Chip models are multi-organ microphysiological platforms composed of interconnected chambers for each cell type or barrier tissue of interest. These human organ mimics use either primary (from patient donors) or induced pluripotent stem cell (iPSC) derived. Currently consisting of up to six different organ types, microelectrode arrays (MEA) and microcantilevers are used to monitor the real time function including force generation and electrical activity of cells representing the organ mimic over time as compounds are dosed and circulate throughout the system. These non-invasive readouts of tissue function are direct indicators of cell health and reduce reliance on biomarkers that rely on cell death. Each organ model is monitored for up to 28-days in a single system allowing real time tracking of functional changes in response to treatments.

 

Our Human-on-a-Chip system is capable of multiple applications that can be customized to fit the customer’s needs. Our services can utilize phenotypic cellular assays to filter the vast number of hits and leads evaluated on a daily basis by pharmaceutical companies or be customized to address other specific needs. As a platform technology, there are many drug discovery applications that can be developed. We plan to initially focus on toxicology studies as well as analytic drug development services for the pharmaceutical industry.

 

Our Human-on-a-Chip systems could transmit massive amounts of data in very short amounts of time utilizing communication systems that are currently in the market. We plan to develop the ability to display the actual recordings synchronous with each functional readout. We believe that the ability to view results in real time would be valuable to our end-user customers because it enhances a drug developer’s ability to iterate in collaboration with our scientists without the time and cost associated with more traditional methods.

 

 

4 McAleeer et al., Multi-organ system for the evaluation of efficacy and off-target toxicity of anticancer therapeutics,

Science Translational Medicine. 11:eaav1386 (2019).

5 McAleer et al., On the potential of in vitro organ-chip models to define temporal pharmacokinetic-pharmacodynamic relationships, Sci. Rep. 9:9619 (2019).

6 Rumsey et al., Classical Complement Pathway Inhibition in a “Human-On-A-Chip” Model of Autoimmune Demyelinating Neuropathies, Advanced Therapeutics 2022:2200030 (2022).

 

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The primary business focus of Hesperos is on customized systems composed of select organs that can be configured based on customer needs. Our technology and services provide research teams the opportunity to determine how the human body will respond when new drug compounds or drug combination are introduced for both efficacy and toxicity in the same platform that enables interlinked organs, including: heart, liver, lung, brain, skin, muscle, kidney, GI tract, immune, neuromuscular and more.

 

We currently also offer four basic Human-on-a-Chip models, including: (i) Heart-Liver two-organ model, (ii) Neuromuscular (NMJ) junction two organ model, (iii) Heart-Liver-Cancer three organ model and (iv) Heart-Liver Skeletal Muscle neuron four organ, each as described below:

 

Heart-Liver Two-Organ Model. Our two-organ Human-on-a-Chip heart-liver model is well-suited for investigations into the efficacy and safety of novel chemicals and biologics as well as their metabolites. The system combines sophisticated, noninvasive functional readouts of cardiomyocyte syncytium contractile force generation, beat frequency, and field potential duration (QT interval surrogate). In its current configuration, this model strives to replace the FDA-ICH approved whole-heart perfusion animal models in drug discovery and development. Additionally, our cardiomyocyte models adhere to the Comprehensive in vitro Proarrhythmia Assay (CiPA) Initiative guidelines concerning torsadogenic potential (TdP) risk. This two-organ model has been characterized for acute cardiotoxicity and hepatotoxicity using noninvasive and endpoint functional and biomarker readouts. This model has been routinely operated for 14 days, and therefore, is well-suited for acute and chronic dosing studies for drug efficacy and safety.

 

Neuromuscular (NMJ) Junction Two-Organ Model. Our Human-on-a-Chip, two-organ NMJ model is uniquely-suited for investigations into the physiology of NMJ formation, stability and synchronous activity between motoneuron (MN) neurotransmitter release and skeletal muscle (myotubes) contraction. Our microtunnel barrier system (MBS) separates the medium compartments of the MNs and myotubes while facilitating axonal outgrowth and innervation. This unique design allows for drugs to be tested on one or both sides to determine site of action. We have extensively characterized this model’s response to common NMJ disrupting toxins, even reproducing the biphasic dose response of tubocurarine toxin. Additionally, our healthy patient iPSC-derived MNs can easily be substituted for disease patient iPSCs carrying genetic mutations for common NMJ diseases such as amyotrophic lateral sclerosis (ALS).

 

Heart-Liver-Cancer Three-Organ Model. Our human cancer cell modules are well-suited for investigations into novel chemotherapeutic efficacy and, when integrated with a multi-organ system, for therapeutic index determination. We have characterized a heart-liver-cancer three-organ Human-on-a-Chip model and shown drug efficacy, safety and metabolite formation for monotherapy and combinatorial therapy approaches using multi-drug resistant (MDR) and non-MDR cancer cells.

 

Heart-Liver Skeletal Muscle Neuron Four-Organ Model. Our four-organ Human-on-a-Chip model has been extensively characterized for baseline physiology using MEA and cantilever-based functional readouts along-side standard biomarker readouts. In this model, we noninvasively monitor cardiomyocyte syncytium contractile force generation, beat frequency, and field potential duration (QT interval surrogate). We also noninvasively monitor skeletal muscle force generation and neuron spontaneous action potential generation. Endpoint assays for liver physiology include albumin and urea production. We also monitor industry standard metrics including cell viability and a range of biomarker readouts based on customer experimental design. This model has been routinely operated for 28 days, and therefore, is well-suited for acute and chronic dosing studies for drug efficacy and safety.

 

Barrier Tissue Modules

 

We also offer barrier tissue models that are easily integrated with our standard housing designs. Adding these modules to our platforms enables determination of transport characteristics of novel compounds as well as their responses as toxicity targets. Additional information regarding drug safety for barrier tissues and first-pass metabolism in gastrointestinal tract can also be determined. In the context of disease models, barrier tissues composed of mutant iPSC-derived cells can be incorporated to investigate the role these diseased tissues play in disease pathology and etiology in a controlled, human-based model.

 

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Blood-Brain Barrier (BBB Model). Our BBB model, composed of human iPSC-derived and primary cells, has been extensively characterized for tight junction-mediated barrier formation and paracellular (passive) and transcellular (active) transport mechanisms. This module is well-suited for investigating the transport rates, transport mechanisms and barrier effects of novel chemicals and biologics.

 

Gastrointestinal Tract (GI Tract Model). Using either iPSC-derived enterocytes, or immortalized patient biopsy intestinal epithelial cells (hiECs), the absorption and first-pass metabolism characteristics of a novel compound can be determined. Our hiEC model has been characterized for CYP activity and barrier formation.

 

Kidney Renal Proximal Tubule (RPT Model). Using primary renal proximal tubule cells, the tubular reabsorption or secretion profile of a novel compound can be determined for excretion purposes. Additional data regarding the kidney safety profile of a drug can be collected in the form of barrier integrity changes (noninvasive TEER measurements) and release of the biomarker kidney injury marker-1 (KIM-1).

 

Skin. Using Strat-M® membranes, a synthetic human skin module, integrated into our multi-organ systems, we can determine the transdermal diffusion of novel compounds applied topically and monitor the effects of the absorbed drugs on organ physiology in the system. We have characterized a heart-liver-skin HoaC model for the effects of topically-applied drugs including hydrocortisone, ketoconazole and diclofenac.

 

Monocytes/Macrophages. Monocytes can be added to the recirculating medium in our multi-organ systems. These cells (THP-1 monocytes) have been characterized in systems for expression of the lineage markers CCR5, CD14 and CD16 as well as markers of activation including CD11b, CD69 and CD86 following exposure to lipopolysaccharide (LPS) and interferon-gamma (IFN-γ). Additionally, following exposure to LPS and IFN-γ the monocytes have been shown to differentiation into macrophages and adhere to damaged tissue modules. Differential cytokine release profiles have also been characterized in the context inactivated, tissue damage-activated and cytokine storm activated conditions.

 

Pharmacokinetic/Pharmacodynamic Modeling (CFD Modeling). Our recirculating medium allows for complex pharmacokinetic profiles of compounds and metabolic products through absorption, distribution, metabolism, and elimination (ADME) depending on the organ systems incorporated. We have extensive experience coupling HPLC-MS data with modeling of these systems through computational fluid dynamics (CFD) and other numerical methods to produce pharmacokinetic profiles both in different medium compartments and accumulated in the cells. Coupled with our functional measurements, we have the capabilities to generate Pharmacokinetic-Pharmacodynamic (PK-PD) relationships.

 

High-Performance Liquid-Chromatography Mass Spectroscopy (HPLC-MS). Using our Agilent Technologies HPLC-MS, we can quantify the concentration of drug in systems at any point during an experiment. Additionally, in any liver-containing HoaC system, we can determine concurrent depletion of parent compound and metabolite generation.

 

Grant Funding

 

To date, the majority of funding for our operations has come through NIH grants. As of March 31, 2022, we have received approximately $17.5 million in funding from SBIR grants from the NIH, with approximately an additional $4.2 million of grants authorized and available for use as of March 31, 2022 and approximately an additional $3.2 million of grants remaining available for use through 2024, subject to availability of funds and satisfactory progress of each project as determined by the NIH.

 

Each of the grants awarded to us relate to agreed-upon direct and indirect costs for specific research and development activities, which may include personnel and consulting costs, costs paid to CROs and research institutions, and administrative costs, among others. We receive the right to receive funds under the grant on a cost reimbursement basis up to the maximum amount of each specific grant award and we are under no obligation to achieve any identified results or conclusions just to file the appropriate progress reports on an annual basis. Only costs that are allowable under the grant award, certain government regulations, and the NIH’s supplemental policy and procedure manual may be claimed for reimbursement, and the reimbursements are subject to routine audits from governmental agencies from time to time. While these NIH grants do not contain payback provisions or milestone requirements, the NIH or another government agency may review our performance, cost structures and compliance with applicable laws, regulations, policies and standards and the terms and conditions of the applicable NIH grant. If any of our expenditures are found to be unallowable or allocated improperly of if we have otherwise violated terms of any NIH grant, the expenditures may not be reimbursed or we may be required to repay funds already disbursed. To date, we have not been found to have breached the terms of any NIH grant and have successfully passed NIH audits for the years 2017-2021 with no adverse findings.

 

Strengths and Competitive Advantages

 

We believe that our Human-on-a-Chip systems have the potential to disrupt the current infrastructure in the pre-clinical phase of drug development and address a major unmet need for rare diseases. We believe that our Human-on-a-Chip system should deliver the following key advantages over other competing systems:

 

Single Integrated System

 

Our system determines efficacy and off-target toxicity for both single compound treatments and drug combinations in interconnected, multi-organ human based systems. Many of our competitors focus on single organ toxicity. To our knowledge, our device is the only system on the only multi-organ system on the market that maintains physiological relationships among components allowing research teams to determine the effectiveness of a drug compound (and its metabolites) while monitoring the effect on other organs in one system.

 

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Flexibility

 

Our systems may include up to six different organ types, which can each be interchanged to investigate various reactions and types of diseases. Current organ models can include the cardiac system, liver, muscle, kidney and brain in addition to barrier tissues such as the blood-brain barrier, intestine and skin as well as recirculating immune cells.

 

Scalability

 

The patented, pumpless system better represents in vivo conditions by providing a low volume environment so metabolites can be generated at significant concentrations if a liver is present. By only requiring milligrams of candidate compounds (compared to kilograms required for animal models), our systems allow medicinal chemists to investigate several options prior to scaling development for animal testing or clinical applications. It also allows recirculating cells that normally would be damaged by pumped systems.

 

Superior Interaction among Components

 

Our systems recirculate serum-free media, which represents a blood surrogate circulation while maintaining cell viability and differentiation for up to 28-days while maintaining defined components. Serum-free media allow for better definition of mechanistic interactions among organs than serum-containing media.

 

Proven Experience of our Founders

 

Our founders, Drs. Shuler and Hickman, both have over 30 years of experience with microphysiological systems. Dr. Shuler is recognized in the industry as the founder of the organ-on-a-chip field.

 

Growth Strategies

 

Our goal is to pursue greater commercial adoption of our human-based preclinical models to facilitate pharmaceutical companies in selecting which drug will be most likely to succeed in clinical trials at the medicinal chemistry stage. A modest increase in success in clinical trials will greatly reduce the cost of drug development. We believe that our services will allow pharmaceutical companies to better determine which drug candidates will likely fail and which will likely succeed which in turn should lead to more life-saving or life-enhancing drugs at lower costs of discovery. We believe our services will be a significant resource to the rare disease community.

 

As a platform technology, our services can be used to develop many drug discovery applications for both efficacy and safety evaluations. As a small company, we have limited resources to address the multitude of applications suitable for our platform technology and will initially focus on efficacy studies and analytic drug development services for the pharmaceutical industry, especially for rare diseases. Thus, our near term business strategy is to continue technology development of the Hesperos platform to decrease the cost of each evaluation, demonstrate its utility in specific services that the Company will offer, optimize the platform for reproducibility and scalability and develop other applications in collaboration with a limited number of long-term corporate partners.

 

We intend to use the proceeds from this offering to further enhance functionality and expand applications. We may expand the number of organ types and organ combinations in our systems, as well as increase the actual number of our systems in order to serve a greater number of customers, which we believe is the primary factor limiting our revenue growth. Our systems are assembled manually and, during operation, they need to be removed from the constant temperature and atmospheric incubators for functional measurements. In addition, surface modifications of the organ chips and subsequent plating of cells on the modified surfaces is done manually. We intend to use the proceeds from this offering to enhance the repeatability and reliability of our system by improving the automation of the fabrication and measurement processes. In addition, we intend to build additional platforms and systems to allow us to further diversify the components for our platforms and to conduct additional projects based upon anticipated demand from our existing and new customers. However, our ability to develop and implement the automation of our fabrication and measurement processes which will enable increased efficacy and reliability may face implementation challenges that may not all be addressed with proceeds from this offering. Further, the continued development of our technology may be more expensive or take longer than we expect and we may not be successful in such efforts.

 

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Properties

 

Our Company’s offices are in a 14,100 square foot facility located in Central Florida Research Park at 12501 Research Pkwy #100, Orlando, FL 32826. We have leased the facility through February 1, 2028.

 

Competition

 

We are subject to general competition from pharmaceutical and biotechnology companies; academic and research institutions; and government or other publicly-funded agencies that are pursuing the development of tissue models and therapeutic products targeted to our potential customers and market opportunities. We believe our success will depend, in large part, on our ability to maintain a first mover advantage and competitive lead in our industry by focusing on customization for customer needs.

 

The drug discovery industry is dominated by a handful of large global multilateral corporations complemented by hundreds of small to medium sized biotechnology companies while organ-on-a-chip service companies are a newly created market niche. We believe this science has reached a tipping point and has generated a number of niche-focused competitors, most of which have emerged from the University setting.

 

Competition arises mainly from two sources, traditional cell-based in vitro culture approaches and traditional in vivo animal models and testing from companies like TissUs, Emulate, HuREL, Mimetas, Hepregan, InSphero, CN Bio Innovations, Nortis, Organovo, TARA Biosystems, Scikon, 4Design Bioscience and RegeneMed.

 

Intellectual Property

 

Our success will depend in large part on our ability to:

 

  obtain and maintain international and domestic patent and other legal protections for the proprietary technology, inventions and improvements we consider important to our business;
     
  prosecute and defend our future patents, once obtained;
     
  preserve confidentiality of our own and our licensed methods, processes and know-how; and
     
  operate without infringing the patents and proprietary rights of other parties.

 

We intend to seek appropriate patent protection for technology in our research and development programs, where applicable, and their uses by filing patent applications in the United States and other selected countries. We intend for these patent applications to cover, where possible, claims for compositions of matter, medical uses, processes for preparation and formulations.

 

Our current patent portfolio consists of 41 exclusive and non-exclusive patents licensed from UCF and Cornell University (“Cornell”). Under the terms of these licenses, we owe royalties from sales for services or products that use such licensed patents to the licensing universities. Such royalties range from 0.5% to 1.5% based upon the particular license and the amount of sales. If certain patents are sublicensed, 20% of such sublicense compensation would be owed to the licensor. In connection with this offering, UCF has the anti-dilution right to receive up to 30,000 additional shares of our common stock. UCF’s anti-dilution rights will terminate upon completion of this offering.

 

Under the terms of the License Agreement by and between us and Cornell University, dated August 31, 2015 (the “Cornell License”), we were granted a non-exclusive right to practice the invention claimed in U.S. Patent No. 8,748,180 (the “‘180 Patent”) in the United States. The ‘180 Patent is directed to a microfluidic device for culturing cells and/or tissue. The ‘180 Patent also contains claims directed to a method of culturing cells or tissues and a method of performing an assay of an effect of a test substance on those cells or tissues. The ‘180 Patent is scheduled to expire no earlier than July 29, 2030. The Cornell License may be terminated by Cornell if we fail to perform or violate any term of the Cornell License upon prior written notice to us by Cornell of a default and failure by us to cure such default within 60 days of receipt of such written notice. Cornell may also terminate the Cornell License immediately upon the filing by us of a claim challenging the validity or enforceability of the ‘180 Patent. Cornell retains all decisions with respect to the filing, prosecution, and maintenance of the ‘180 Patent. We consider the ‘180 Patent to be material to our business because we utilize the pumpless feature claimed in the ‘180 Patent in almost all, if not all, of our current and contemplated microphysiological systems.

 

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Under the terms of the License Agreement by and between us and the University of Central Florida Research Foundation, acting as a designee for and instrumentality of us, dated October 6, 2015 (the “UCF License”), as amended on September 16, 2016, October 30, 2016, and April 26, 2022, we were granted a royalty-bearing, exclusive, sublicensable right to practice the inventions claimed in the table below, including an option to take a license under any inventions conceived of or created by Dr. Hickman subsequent to the October 6, 2015 effective date of the UCF License. The UCF License may be terminated by UCF upon breach of the UCF License by us and by 60 days prior written notice to us by UCF of such breach. Otherwise, the UCF License expires on the expiration date of the last patent covered by the UCF License. UCF received 281,250 shares of our common stock in exchange for the grants under the License Agreement.

 

The following tables describe the UCF intellectual property portfolios with respect to patents with Dr. Hickman as inventor and with Dr. Hickman and UCF as joint owners. Patents which we consider material to our business are denoted with an asterisk, and the specific technology to which such patents relate is included in the column titled “Title and Subject Matter”, and each material patent is either currently or expected to be incorporated into our systems:

 

UCF IP Portfolio with James Hickman as Inventor

 

UCF

ID #

  Docket #   Serial/Patent #   Title and Subject Matter   Inventors   Status   Scheduled Exp. Date   Annuities
33404   10613-011US2   10,386,360   Bio-microelectromechanical system transducer and associated methods   James Hickman  

Issued

  12/3/2030  

Current

                             
31821   10613-012US1   8,815,584   Method of co-culturing mammalian muscle cells and motoneurons    James Hickman, Mainak Das  

Issued

  TD: 7/27/2031  

Current

                             
33024   10613-012US2   9,650,606   Method of co-culturing mammalian muscle cells and motoneurons (CON)    James Hickman, Mainak Das  

Issued

  12/7/2030  

Current

                             
33675   10613-012US3   10,266,804   Method of co-culturing mammalian muscle cells and motoneurons   James Hickman, Mainak Das  

Issued

  4/23/2030  

Current

                             
32132*   10613-013US1   9,952,204   Formation of neuromuscular junctions in a defined system    James Hickman, Xiufang Guo, Maria Stancescu, Mercedes Gonzalez  

Issued

 

TD: 4/23/2030

 

 

Current

                             
33973   10613-014BE1   2585171   Formation of neuromuscular junctions in a defined system   James Hickman, Xiufang Guo   Issued   5/6/2031   Current

 

51

 

 

32605   10613-014CA1   2,798,777   Formation of neuromuscular junctions in a defined system    James Hickman, Xiufang Guo   Issued   5/6/2031   Current
                             
33971   10613-014CH1   2585171   Formation of neuromuscular junctions in a defined system   James Hickman, Xiufang Guo   Issued   5/6/2031   Current
                             
33972   10613-014DE1   602011055172.8   Formation of neuromuscular junctions in a defined system   James Hickman, Xiufang Guo   Issued   5/6/2031   Current
                             
32606   10613-014EP1   2585171   Formation of neuromuscular junctions in a defined system    James Hickman, Xiufang Guo   Issued   5/6/2031    
                             
33970   10613-014FR1   2585171   Formation of neuromuscular junctions in a defined system   James Hickman, Xiufang Guo   Issued   5/6/2031   Current
                             
33974   10613-014NL1   2585171   Formation of neuromuscular junctions in a defined system   James Hickman, Xiufang Guo   Issued   5/6/2031   Current
                             
33969   10613-014UK1   2585171   Formation of neuromuscular junctions in a defined system   James Hickman, Xiufang Guo   Issued   5/6/2031   Current
                             
32604*   10613-014US1   8,835,168   Synthetic mammalian neuromuscular junction and method of making    James Hickman, Xiufang Guo  

Issued

  4/23/2030  

Current

                             
33052*   10613-014US2   9,267,936   Synthetic mammalian neuromuscular junction and method of screening for a candidate drug thereon    James Hickman, Xiufang Guo  

Issued

  TD: 4/23/2030  

Current

                             
31820   10613-015US1   9,163,216   Method for culturing skeletal muscle for tissue engineering   James Hickman, Mainak Das, John Rumsey  

Issued

  7/27/2031  

Current

 

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33369   10613-015US2   10,160,953   Improved method for culturing skeletal muscle for tissue engineering   James Hickman, Mainak Das, John Rumsey  

Issued

  TD: 4/23/2030  

Current

                             
31869   10613-017US1   8,828,721   Method of myelinating isolated motoneurons   James Hickman, John Rumsey  

Issued

  11/18/2031  

Current

                             
32016*   10613-019US1   9,404,140   Patterned cardiomyocyte culture on microelectrode array   James Hickman, Peter Molnar, Anupama Natarajan, Maria Stancescu  

Issued

  6/2/2033  

Current

                             
33468*   10613-019US2   15/190,958   Patterned cardiomyocyte culture on microelectrode array   James Hickman, Peter Molnar, Anupama Natarajan, Maria Stancescu  

Pending

  No earlier than 11/3/2030    
                             
32856   10613-022EP1   2710120   Stable electrically active neurons from adult tissue   James Hickman, Darin Edwards   Issued   5/17/2032    
                             
34566   10613-023US2   16/985,744   Methods, systems and compositions for in vitro cellular models of mammalian systems   James Hickman   Pending   No earlier than 8/17/2032    
                             
33880   10613-026BE1   2951281   Devices and systems for mimicking heart function  

James Hickman; Christopher Long; Christopher McAleer; Peter Molnar; Maria Stancescu

 

 

Issued

  1/30/2034  

Current

33306   10613-026CA1   2,899,445   Devices and systems for mimicking heart function  

James Hickman; Christopher Long; Christopher McAleer; Peter Molnar;

Maria Stancescu

 

Pending

  No earlier than 1/30/2034    
                             
33879   10613-026CH1   2951281   Devices and systems for mimicking heart function  

James Hickman; Christopher Long; Christopher McAleer; Peter Molnar; Maria Stancescu

 

 

Issued

  1/30/2034  

Current

33878   10613-026DE1   602014027552.4   Devices and systems for mimicking heart function  

James Hickman; Christopher Long; Christopher McAleer; Peter Molnar; Maria Stancescu

 

 

Issued

  1/30/2034  

Current

33307   10613-026EP1   2951281   Devices and systems for mimicking heart function  

James Hickman; Christopher Long; Christopher McAleer; Peter Molnar;

Maria Stancescu

 

Issued

  1/30/2034    

 

53

 

 

33877   10613-026FR1   2951281   Devices and systems for mimicking heart function  

James Hickman; Christopher Long; Christopher McAleer; Peter Molnar; Maria Stancescu

 

 

Issued

  1/30/2034  

Current

33411   10613-026HK1   HK1211976   Devices and systems for mimicking heart function  

James Hickman; Christopher Long; Christopher McAleer; Peter Molnar;

Maria Stancescu

 

Issued

  1/30/2034  

Current

                             
33881   10613-026NL1   2951281   Devices and systems for mimicking heart function  

James Hickman; Christopher Long; Christopher McAleer; Peter Molnar; Maria Stancescu

 

 

Issued

  1/30/2034  

Current

33876   10613-026UK1   2951281   Devices and systems for mimicking heart function  

James Hickman; Christopher Long; Christopher McAleer; Peter Molnar;

Maria Stancescu

 

Issued

  1/30/2034  

Current

                             
34458*   10613-026US2   16/913,528   Devices and systems for mimicking heart function  

James Hickman; Christopher Long; Christopher McAleer; Peter Molnar;

Maria Stancescu

  Pending   No earlier than 1/30/2034  
                             
33288*   10613-029US1   10,935,541   Devices and methods comprising neuromuscular junctions   James Hickman, Christopher Long, Kristen Pirozzi, Alexander Smith  

Issued

  6/17/2037  

Current

                             
34040   10613-045US1   11,022,605   Multi-Component In Vitro System To Deduce Cell Signaling Pathways By Electronic Stimulation Patterns   James Hickman, Lee Kumanchik, Navaneetha Santhanam  

Issued

  11/28/2037  

Current

                             
34073   10613-063US1   16/381,660   Model for fluid and mass transport in a recirculating microfluidic system   James Hickman, Christopher Long, Kazi Tasneem  

Pending

  No earlier than 4/11/2039    

 

54

 

 

UCFRF Jointly Owned Portfolio with James Hickman as Inventor

 

UCF ID #   Docket #   Serial #   Title   Inventors   Status   Scheduled Exp Date   Joint Owner
34194   10613-052CA1   3,048,884   Pumpless microfluidic organ-on-a-chip system including a functional immune system   James Hickman, Alisha Colon, Daniel Elbrecht, Christopher McAleer, John Rumsey, Trevor Sasserath  

 

Pending

  No earlier than 12/29/2037   Licensee
                             
34198   10613-052EP1   17885858.5   Pumpless microfluidic organ-on-a-chip system including a functional immune system   James Hickman, Alisha Colon, Daniel Elbrecht, Christopher McAleer, John Rumsey, Trevor Sasserath  

 

Pending

  No earlier than 12/29/2037   Licensee
                             
34431   10613-052HK1   62020006877.8   Pumpless microfluidic organ-on-a-chip system including a functional immune system   James Hickman, Alisha Colon, Daniel Elbrecht, Christopher McAleer, John Rumsey, Trevor Sasserath  

 

Pending

 

  No earlier than 12/29/2037   Licensee
                             
34193   10613-052US1   16/474,768   Pumpless microfluidic organ-on-a-chip system including a functional immune system   James Hickman, Alisha Colon, Daniel Elbrecht, Christopher McAleer, John Rumsey, Trevor Sasserath  

 

Pending

  No earlier than 12/29/2037   Licensee
                             
34172*   10613-065US1   16/534,624   Method and system for printing cells to a substrate comprising cell adhesive regions   James Hickman, Megan Aubin, Sandra Rothemund, Frank Alexander  

 

Pending

  No earlier than 8/7/2039   Licensee

 

55

 

 

Dr. Hickman has pioneered the concept of functional tissue constructs for skeletal muscle (U.S. Patent Nos. 9,163,216 and 10,160,953), cardiac muscle (U.S. Patent No. 9,404,140), neuromuscular junction (U.S. Patent Nos. 8,815,584; 8,835,168; 9,267,936; 9,952,204; 9,650,606; 10,266,804; CA Patent No. 2,798,777; and EP Patent No. 2585171), and is currently developing one for the lung. The most recent patent application filed by Dr. Hickman (U.S. Patent Application No. 16/985,744) describes compositions, methods, and systems relating to functional in vitro cell culture devices to mimic mammalian organ systems. Key improvements include: serum free media, physiologically functional cells, functional readouts for real time monitoring and PKPD models to predict clinical outcomes. Although we do not own the patents held by UCF and Cornell, we are able to use the patents through the Cornell License and the UCF License.

 

Besides relying on patents, we also rely on trade secrets, proprietary know-how and continuing innovation to develop and maintain our competitive position, especially when we do not believe that patent protection is appropriate or can be obtained. We seek protection of these trade secrets, proprietary know-how and any continuing innovation, in part, through confidentiality and proprietary information agreements. However, these agreements may not provide meaningful protection for, or adequate remedies to protect, our technology in the event of unauthorized use or disclosure of information. Furthermore, our trade secrets may otherwise become known to, or be independently developed by, our competitors.

 

Regulation

 

Our services are not subject to regulation by the U.S. Food and Drug Administration (FDA). Marketing our services does not require pre-market clearance or approval by FDA. The FDA and comparable regulatory authorities in state and local jurisdictions and in other countries impose substantial requirements upon companies involved in the clinical development, manufacture, marketing and distribution of drugs, as well as medical devices. These agencies and other federal, state and local entities regulate, among other things, the research and development, testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion, distribution, post-approval monitoring and reporting, sampling and export and import of drug candidates whose pharmaceutical companies may use our services in their pre-clinical trials. While we are not subject to FDA clearance or approval of our systems, we believe FDA approval of our customer’s drug candidates that utilize our data to support their regulatory submissions validates our systems and could provide a competitive advantage.

 

U.S. Government Regulation

 

The FDA generally regulates advertising, promotion, sale, and distribution, in interstate commerce, of medical devices. Devices subject to FDA regulation must undergo pre-market clearance or approval prior to commercialization unless the device is of a type exempted from such review. Additionally, medical device manufacturers must comply with various regulatory requirements under the Federal Food, Drug and Cosmetic Act and regulations promulgated under that Act, including quality system review regulations, unless exempted from those requirements for particular types of devices. Entities that fail to comply with applicable FDA requirements can be liable for criminal or civil penalties, such as recalls, detentions, orders to cease manufacturing and restrictions on labeling and promotion.

 

Clinical laboratory services are not subject to FDA regulation and, thus, our Human-on-a-Chip platform and related services are not currently regulated by the FDA. There is a risk that the FDA could develop new regulations or guidance that would subject our systems to FDA regulation, e.g., the need to seek FDA regulatory clearance of approval. If the FDA determines that any of our current or future pre-clinical analytical services are regulated as medical devices, we would become subject to various requirements under the FDCA and the FDA’s implementing regulations.

 

Pre-clinical studies

 

The FDA’s good laboratory practices (GLP) regulations do not apply to preclinical feasibility studies conducted in the early phases of product development or nonclinical effectiveness studies. Basic exploratory studies carried out to determine whether a drug candidate has any potential utility are not subject to the FDA’s GLP regulations. A portion of our facility has GLP compatibility so we may move our services toward more clinical applications.

 

56

 

 

Before testing any biological product candidate in humans, the product candidate must undergo rigorous pre-clinical testing. The pre-clinical developmental stage generally involves laboratory evaluations of drug chemistry, formulation and stability, as well as studies to evaluate toxicity in animals, to assess the potential for adverse events (AEs) and, in some cases, to establish a rationale for therapeutic use. The conduct of pre-clinical studies is subject to federal regulations and requirements, including GLP regulations for safety and toxicology studies. An investigational new drug (IND) sponsor must submit the results of the pre-clinical studies, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND.

 

An IND is a request for authorization from the FDA to administer an investigational product to humans and must become effective before human clinical trials may begin. As we coordinate with our pharmaceutical partners to generate data for INDs, there may be instances where we need to perform our services in GLP facilities. An IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions before that time related to one or more proposed clinical trials and places the trial on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.

 

To provide our pharmaceutical partners with confidence that the FDA will not raise concerns about an IND that uses data generated by our services and will ultimately issue an IND for a product candidate that uses such data to support an IND submission, we are working to increase the level of scientific and market recognition of the scientific validity of our services as a normal part of the drug discovery process by regulators such as the FDA, and our systems have been the subject of numerous peer-reviewed articles and publications, including a publication for Sanofi describing an IND that was approved that used data generated by our systems. We believe the more familiar FDA is with our services, the more likely FDA is to accept IND submissions that include data generated by our services.

 

Employees

 

As of December 31, 2021, we had 27 full-time employees, 8 part-time employees, and 2 contractors. None of our employees are represented by a labor union or covered by a collective bargaining agreement. We consider our relationship with our employees to be satisfactory.

 

Legal Proceedings

 

From time to time we may be named in claims arising in the ordinary course of business. Currently, no legal proceedings, government actions, administrative actions, investigations or claims are pending against us or involve us that, in the opinion of our management, could reasonably be expected to have a material adverse effect on our business and financial condition.

 

Although we will depend in part upon the licensors of our licensed patents to pursue or defend any claim of infringement, we may be required to expend significant financial and managerial resources in the defense of our intellectual property rights in the future if we believe that such rights have been violated or to defend against claims that our products and services infringe upon the intellectual property rights of third parties.

 

Corporate Information

 

Hesperos, Inc. was incorporated as a Delaware corporation in 2015. Our principal executive offices are located at 12501 Research Parkway, Suite 100 in Orlando, Florida and our phone number is (407) 900-5915. Our Internet website can be found at www.hesperosinc.com. Our website and the information contained in our website or connected to our website are not and will not be deemed to be incorporated into this prospectus or the Registration Statement of which this prospectus forms a part, and you should not consider such information part of this prospectus or rely on any such information in making your decision whether to purchase our common stock.

 

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MANAGEMENT

 

Officers, Directors and Director Nominees

 

The following table provides information regarding our executive officers, directors, and director nominees, including their age, as of June 30, 2022:

 

Name   Age   Position
James F. Kronauge, Jr., Ph.D.   67   Chief Executive Officer
Kenneth D. Najour, DBA, CPA   63   Chief Financial Officer
Michael L. Shuler, Ph.D.   75   President and Director
James J. Hickman, Ph.D.   64   Chief Scientist and Chairman of the Board
Gilberto M. Villacorta, Ph.D.   65   Vice President and Secretary
Antonio Marra, Jr.   59   Director
James Stanker   64   Director
Kathryn O’Connor Gardner   47   Director

 

 

 

Business Experience

 

The following is a brief account of the education and business experience of our current directors, director nominees, and executive officers:

 

James F. Kronauge, Jr., Ph.D. – Dr. Kronauge has served as our Chief Executive Officer since April 1, 2022. Dr. Kronauge has over 30 years of experience developing radiopharmaceuticals for medical imaging. Since 2021, he has served as the Co-Founder and President of iSeek Biopharma, Inc. where he has supported the clinical testing and development of a novel immune-cell targeting agent for various diagnostic and therapeutic applications in multiple immune associated conditions and where he continues to serve as President on a non-salary basis. Since 2018, Dr. Kronauge has served as the Vice President of Process Development at Cystosite Biopharma Inc., where he manages, directs, and controls the development and production of a radioactive test article, and has also served as a Radiochemistry and Product Development Consultant to InviCRO LLC (“Invicro”), a contract research organization preeminent in the use of imaging for translational drug discovery and development. He also served as the Vice President of Chemistry of Invicro from 2013-2018. From 2018 to 2021, Dr. Kronauge acted as the President and Co-Founder of Tomopath where he directed and managed drug development and designed and generated regulatory applications for clinical trials to the FDA and EMEA. Prior to his positions with Invicro, Dr. Kronauge served as the Executive Director of Research and Development and then as the Vice President of Process Development Chemistry at Molecular Insight Pharmaceuticals Inc. Earlier in his career, Dr. Kronauge taught as an Assistant Professor of Radiology at the Harvard Medical School for 13 years. From 1990 to 2018, Dr. Kronauge served on a number of journal review boards, including the Journal of Nuclear Medicine, Nuclear Medicine and Biology, European Journal of Nuclear Medicine, Nuclear Medicine and Biology, Molecular Imaging and Cancer Research. He received his B.S. in chemistry from Kent State University in 1978 and his Ph.D in inorganic chemistry from the Massachusetts Institute of Technology in 1987.

 

Kenneth D. Najour, DBA, CPA – Dr. Najour has served as our Chief Financial Officer since June 2022. Since August 2021, Dr. Najour has served as a Visiting Professor of Accounting at Stetson University. Dr. Najour has over 30 years of financial, operational, and executive leadership experience in real estate, financial services, consumer products and public accounting. From August 2016 to June 2018, Dr. Najour served as the Chief Financial Officer of Elevation Financial Group, LLC, a private equity firm in the residential real estate market. Dr. Najour served in various roles, including as the Chief Financial Officer and as the Chief Accounting Officer, of Altisource Asset Management Corporation, a real estate and mortgage company that provides asset management and corporate governance services to Front Yard Residential Corporation (NYSE: RESI) from 2013 to 2016. Dr. Najour served as Vice President, Finance and Chief Accounting Officer of Ocwen Financial Corporation from 2010 to 2013 and served as the Senior Vice President, Chief Financial Officer of the Latin America and Caribbean Region for Mastercard Inc. from 2003 to 2010. He also held leadership positions within PepsiCo. Inc. from 1994 to 2003 and was a Senior Audit Manager at Pricewaterhouse Coopers LLP from 1986 to 1994. He holds a Doctor of Business Administration from the University of Florida, a Master of Accounting from the University of Miami, and a Bachelor of Science from Santa Clara University. He is a licensed Certified Public Accountant in California and Florida.

 

Michael L. Shuler, Ph.D. – Dr. Shuler has served as our President and as a member of our board of directors since our incorporation in 2015 and also served as our Chief Executive Officer until the hiring of Ms. Scanlon in December 2021. Dr. Shuler has over 30 years of experience researching and developing the field of microphysiological systems, including the engineering, invention, and improvement of “body-on-a-chip” technology. From January 1992 through June 2018, Dr. Shuler served as the Samuel B. Eckert Professor of Engineering at Cornell University and, since July 2018, has served as the Samuel B. Eckert Professor of Engineering – Emeritus at Cornell University. For over 45 years, Dr. Shuler has held various professorships and directorships with the School of Chemical Engineering at Cornell University, and he has held several visiting professorship positions with universities such as the University of Queensland, the Institute for Biotechnology, ETH, the University of Wisconsin, Madison, and the University of Washington, Seattle. Dr. Shuler is also widely acknowledged as the first engineer to focus on large-scale plant tissue culture for the production of complex secondary metabolites such as taxol. He has published over 300 peer-reviewed journal articles, holds 14 patents, and has written 8 scholarly textbooks. He holds several honors, including election to the National Academy of Engineering in 1989 and to the American Academy of Arts and Sciences in 1996, among others. Dr. Shuler received his B.S. in chemical engineering from the University of Notre Dame in 1969 and his Ph.D. in chemical engineering from the University of Minnesota in 1973. He also received an Honorory Doctorate from the University of Notre Dame in 2008. As a founder of our Company and as a leading scientist in the field of Human-on-a-Chip technology, we believe Dr. Shuler is qualified to serve as one of our directors.

 

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James J. Hickman, Ph.D. – Dr. Hickman has served as our Chief Scientist and Chairman of our board of directors since our incorporation in 2015. Since 2004, Dr. Hickman has served as a Professor of NanoScience, Chemistry, Biomolecular Science, Physics, and Electrical Engineering at the University of Central Florida, including as the Director of the Nanoscience Center from 2004 through 2008. Through his research, Dr. Hickman has pioneered the establishment of functional in vitro systems, which he has extended to include cardiac, muscle, glia, endothelial, hepatocytes bone marrow, cancer, and epithelial cells. He has also served as an Adjunct Professor at the University of Florida College of Pharmacy since 2017. Dr. Hickman published the first serum-free, defined culture system for neuronal systems in 1995 and was one of the first to report toxicity studies from neurons on microelectrode arrays in a defined system in 1998. His many accomplishments include being awarded the Lush Prize for Science with Dr. Shuler in 2015 and being elected as a member of the board of directors of the American Institute of Medical and Biomedical Engineers, in which he became a Fellow in 2004. He has also been a Fellow of the American Vacuum Society since 2007, the International Academy of Nanobiotechnology since 2019, and the National Academy of Inventors since 2020. Dr. Hickman is the sole or co-inventor on over 40 pending and issued U.S. and international patents, and he has presented over 200 presentations and has authored 161 publications and 20 book chapters. Dr. Hickman received his B.S. in chemistry in 1983 from Penn State University, his M.S. from Penn State University in 1985, and his Ph.D. from the Massachusetts Institute of Technology in 1990. As a founder of our Company and as a leading scientist in the field of Human-on-a-Chip technology, we believe that Dr. Hickman is qualified to serve as a member of our board of directors.

 

Gilberto M. Villacorta, Ph.D. – Dr. Villacorta has served as our Corporate Secretary since our incorporation in 2015 and as our Vice President since January 2022. Since 2006, Dr. Villacorta has held various roles at the law firm Foley & Lardner LLP, where he is a registered intellectual property attorney focusing on establishing, exploiting, and enforcing intellectual property rights in marketable products, systems, and services. He assists technologically diverse clients worldwide with their intellectual property and business transaction needs, including the planning, development, and maintenance of patent and trademark portfolios; intellectual property monetization, licensing, marketing, product development negotiations, and the preparation of the resulting agreements; due diligence investigations in connection with mergers, acquisitions, formation of joint ventures and financing; patentability, registrability, peer review, market assessment, validity and infringement opinions; and enforcement and litigation. He currently serves as the chair of the firm’s Washington, D.C. office Intellectual Property Department. Dr. Villacorta is also the CEO of Emission inc., located in Georgetown, TX, and has served as such since the company’s formation in January 2020. He was born in Manila, the Philippines, and moved to the United States at the age of 16 to pursue his scholastic studies. In 1978 and 1982, he received his A.B. and M.S. degrees, respectively, in chemistry from Rutgers University. He received his Ph.D. for his dissertation and studies in bioinorganic chemistry from the Massachusetts Institute of Technology in 1987 and his J.D. from Fordham University School of Law in 1991. He is admitted to the practice of law in New Jersey, New York and Washington, DC. He was also a Member of Technical Staff at AT&T Bell Laboratories in Murray Hill, NJ from 1981 to 1983.

 

Antonio Marra, Jr. – Mr. Antonio Marra, Jr. has served as one of our directors since our incorporation in 2015, and he currently serves as the Founder, President, and Chief Technologist for Dynamic Analytics and Test, Inc., positions he has held since 1999. His technical background includes over 30 years of experience leading and contributing to the development and fielding of advanced electronic warfare for the U.S. Department of Defense. Additionally, Mr. Marra has also participated in the founding of several technology companies. Mr. Marra’s education consists of a Master of Science in Aeronautics and Astronautics and Master of Science in Technology and Policy from the Massachusetts Institute of Technology in 1988, and a Bachelor of Science in Aeronautics and Astronautics from the Massachusetts Institute of Technology in 1985. We believe that Mr. Marra is qualified to serve as one of our directors due to his business experience and general background in technology.

 

James Stanker - Mr. Stanker has served as one of our directors since May 6, 2022 and as the Chief Financial Officer of Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) since September 5, 2018. Mr. Stanker has over 30 years of financial and executive leadership experience in the areas of accounting principles and audit standards, regulatory reporting, and fiscal management and strategy. He served in a financial leadership role as an audit partner at Grant Thornton from February 2000 until his retirement in August 2016 and has served companies in an advisory role since that time. His responsibilities included managing the audit quality in the Atlantic Coast Market Territory. From 2009 to 2012, he served as the Global Head of Audit Quality for Grant Thornton International. Mr. Stanker is a Certified Public Accountant. He has a Bachelor’s degree in Aeronautics from San Jose State University and a Master’s in Business Administration from California State University, East Bay. He previously served on the Board of Directors of GSE Systems, Inc. Mr. Stanker is also a visiting professor in the George B. Delaplaine School of Business at Hood College. We believe Mr. Stanker is qualified to serve as one of our directors due to his experience and knowledge in accounting, as well as his experience as an officer of a publicly-traded company.

 

Kathryn O’Connor Gardner - Ms. Gardner is an experienced distressed debt investor and has served as one of our directors since May 3, 2022. She also currently serves as the Chairman of the Board of Director and Chair of the Nominating and Governance Committee of GSE Systems, Inc. (NASDAQ: GVP). In 2020, she helped launch Livello Capital, a fund focusing on deep value, event-driven situations. Previously, Ms. Gardner was a Senior Vice President and Corporate Credit Research Analyst within AllianceBernstein’s high-yield research group, focusing on the energy sector. In this role, she oversaw all energy-related investments for traditional high yield portfolios with roughly $35 billion in assets under management. She was also an Investment Committee Member for the Energy Opportunity Funds at AllianceBernstein. Prior to joining AllianceBernstein in 2016, Ms. Gardner was a Managing Director on the sell-side at Deutsche Bank where she covered industries including energy, automotive, and aerospace & defense. Ms. Gardner’s Wall Street experience spans more than 20 years, and she also has experience serving as an advisor for startups on strategy, financial analysis and capital market transactions. Ms. Gardner is a Founding Board Member of the Haas Center for Gender, Equity & Leadership, which seeks to build the economic case for supporting workplace diversity, and is a member of the Haas Dean’s Advisory Board, which brings together the school’s next generation of leaders. Finally, she sits on the board of the CSNK2A1 Foundation, which is focused on finding a cure for an ultra-rare genetic disorder called Okur-Chung Neurodevelopmental Syndrome. Ms. Gardner holds a B.S. in economics and a B.A. in business administration (Walter A. Haas School of Business) from the University of California, Berkeley. We believe Ms. Gardner is qualified to serve as one of our directors due to her financial expertise and prior board experience.

 

Number and Terms of Office of Officers and Directors

 

Upon consummation of this offering, our board of directors will have five members, three of whom will be deemed “independent” under SEC and Nasdaq rules.

 

Our officers are appointed by the board of directors and serve at the discretion of the board of directors, rather than for specific terms of office. Our board of directors is authorized to appoint persons to the offices set forth in our certificate of incorporation as it deems appropriate.

 

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Controlled Company Exemption

 

We will be a “controlled company” within the meaning of the corporate governance standards of Nasdaq. As a controlled company, we will qualify for, and intend to rely on, exemptions from certain of Nasdaq’s corporate governance requirements.

 

Following this offering, as long as Dr. Hickman controls a majority of the voting power of our outstanding shares of common stock with respect to the election of directors, we may utilize certain of these exemptions. Immediately following this offering, we do not expect that the majority of directors on our compensation and nominating and corporate governance committees will be independent. Accordingly, you will not have the same protections afforded to stockholders of companies that are subject to all of the corporate governance requirements of Nasdaq. If we cease to be a “controlled company” and our common stock continues to be listed on Nasdaq, we will be required to comply with these provisions within the applicable transition periods.

 

These exemptions do not modify the independence requirements for our audit committee, and we intend to comply with the requirements of Rule 10A-3 under the Exchange Act and Nasdaq rules within the applicable time frame.

 

Director Independence

 

An “independent director” is defined generally as a person other than an officer or employee of the Company or its subsidiaries or any other individual having a relationship with the Company which, in the opinion of the Company’s board of directors, could interfere with the director’s exercise of independent judgment in carrying out the responsibilities of a director. We have “independent directors” as defined in Nasdaq’s listing standards and applicable SEC rules. Our board of directors has determined that Ms. Gardner and Messrs. Marra and Stanker will be “independent directors” as defined in the Nasdaq listing standards and applicable SEC rules. Our independent directors will have regularly scheduled meetings at which only independent directors are present.

 

Committees of the Board of Directors

 

Our board of directors will have three standing committees: an audit committee, a compensation committee, and a nominating and corporate governance committee. Subject to phase-in rules and a limited exception, the rules of Nasdaq and Rule 10A-3 of the Exchange Act require that the audit committee of a listed company be comprised solely of independent directors. As a controlled company, our compensation committee and nominating and corporate governance committee will not be comprised solely of independent directors. Each committee operates under a charter that has been approved by our board and has the composition and responsibilities described below. The charter of each committee will be available on our website.

 

Audit Committee

 

Upon the effectiveness of the registration statement of which this prospectus forms a part, we will establish an audit committee of the board of directors. Applicable rules of Nasdaq require a listed company’s audit committee to be comprised of three independent directors within one year of listing. Ms. Gardner and Messrs. Marra and Stanker will serve as members of our audit committee. Mr. Stanker will serve as the chairman of the audit committee. Each member of the audit committee will meet the financial literacy requirements of Nasdaq and our board of directors has determined that Mr. Stanker will qualify as an “audit committee financial expert” as defined in applicable SEC rules and has accounting or related financial management expertise.

 

The audit committee’s duties, which are specified in the charter adopted by us and include, but are not limited to:

 

  appointing and overseeing the work of the independent auditor regarding audits and other review or attest services provided by the independent auditor to the Company;
     
  reviewing the qualifications of and appointing the independent auditor for each fiscal year, subject to stockholder ratification;

 

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  pre-approving audit or non-audit services to be provided by the independent auditor and establishing pre-approval policies and procedures;
     
  reviewing the qualifications, performance, independence, and quality control procedures of the independent auditor and its personnel;
     
  meeting with management, the independent auditor, and the internal auditor to discuss the scope of audits, the procedures to be followed, and the staffing of audits;
     
  reviewing with management and the independent auditor major issues and analyses relating to accounting principles and financial reporting, including judgments made in connection with the preparation of the Company’s financial statements and effects of issues on the financial statements;
     
  reviewing and discussing with management and the independent auditor the annual audited financial statements;