As filed with the Securities and Exchange Commission on March 15, 2023.

No. 333-266613

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

AMENDMENT NO. 5 TO

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

MDNA LIFE SCIENCES INC.

(Exact name of registrant as specified in its charter)

2054 Vista Parkway, Suite 400
West Palm Beach, FL 33411

(844) 321-6362

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Christopher C. Mitton

Chief Executive Officer

MDNA Life Sciences Inc.
2054 Vista Parkway, Suite 400

West Palm Beach, FL 33411

(844) 321-6362

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

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: x

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

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

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

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

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided 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 that specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said section 8(a), may determine.  

The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This 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.

SUBJECT TO COMPLETION, DATED MARCH 15, 2023

2,100,000 Units

Each Unit Consisting of

One Share of Common Stock

and 

One Warrant to Purchase One Share of Common Stock

This is the initial public offering of Units (each a “Unit” and collectively, the “Units”) of MDNA Life Sciences Inc (the “Company” or “MDNA”). Each Unit consists of one share of Common Stock, par value $0.0001 per share (the “Common Stock”) and one warrant (each a “Warrant”) to purchase one share of Common Stock. Each Warrant will have an exercise price of $[ ] per share ( % of the offering price per Unit), will become exercisable commencing on the date of issuance, and will expire five years from the date of issuance. The shares of our Common Stock and the Warrants are immediately separable and will be issued separately but will be purchased together in this offering. Prior to this offering there has been no public market for our Common Stock or Warrants. We currently expect the initial public offering price to be between $4.00 and $6.00 per Unit.

We intend to apply to list our Common Stock and Warrants on the Nasdaq Capital Market, or Nasdaq, under the symbol “MDLS” and “MDLSW”, respectively. No assurance can be given that our application will be approved. If our Common Stock and Warrants are not approved for listing on Nasdaq, we will not consummate this offering.

We are an “emerging growth company” as that term is defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and, as such, have elected to take advantage of certain reduced public company reporting requirements for this prospectus and future filings.

Investing in our Common Stock and Warrants involves a high degree of risk. Please read “Risk Factors” beginning on page 15 of this prospectus to read about factors you should consider before buying our Common Stock and Warrants.

We have granted to the representative of the underwriters an option to purchase up to 315,000 additional shares of Common Stock at the initial public offering price and/or Warrants at a purchase price of $0.01 per Warrant, in each case less the underwriting discounts and commissions, for 45 days after the date of this prospectus to cover over-allotments, if any.

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

Delivery of the Units is expected to be made on or about                    , 2023.

Sole Book Running Manager

EF HUTTON 

division of Benchmark Investments, LLC

The date of this prospectus is                       , 2023

TABLE OF CONTENTS

We have not, and the underwriters have not, authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. We and the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the Units offered hereby, but only under the circumstances and in the jurisdictions where it is lawful to do so. The information contained in this prospectus or in any applicable free writing prospectus is current only as of its date, regardless of its time of delivery or any sale of our Units, Common Stock, or Warrants. Our business, financial condition, results of operations and prospects may have changed since that date.

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

Through and including                   , 2023 (25 days after the date of this prospectus), all dealers that buy, sell or trade our Common Stock, whether or not participating in this offering, may be required to deliver a prospectus. This delivery requirement is in addition to the obligation of dealers to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

We use our registered trademarks and trade names, such as Mitomic in this prospectus. This prospectus also includes trademarks, trade names and service marks that are the property of other organizations. Solely for convenience, trademarks and trade names referred to in this prospectus appear without the ^® and ™ symbols, but those references are not intended to indicate that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will not assert its rights, to these trademarks and trade names. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

RISK FACTORS

Investing in our Common Stock and Warrants involves a high degree of risk. You should consider and carefully read all of the risks and uncertainties described below, as well as other information included in this prospectus, including our financial statements and related notes appearing at the end of this prospectus, before making an investment decision. The risks described below are not the only ones facing us. The occurrence of any of the following risks or additional risks and uncertainties not presently known to us or that we currently believe to be immaterial could materially and adversely affect our business, financial condition and results of operations. In such case, the trading price of our Common Stock and Warrants could decline, and you may lose all or part of your investment. This prospectus also contains forward-looking statements and estimates that involve risks and uncertainties. Our actual results could differ materially from those anticipated in the forward-looking statements as a result of specific factors, including the risks and uncertainties described below.

Risks Related to our Business and Industry

We have a history of net losses, and we expect to continue to incur losses for the foreseeable future. If we achieve profitability, we may not be able to sustain it.

We have incurred losses since our inception and expect to continue to incur losses for the foreseeable future. We have reported net losses of $6,065,868 and $2,999,522 for the years ended September 30, 2022 and 2021, respectively and a net loss of $1,542,267 for the three months ended December 31, 2022. As a result of these losses, as of December 31, 2022, we had $219,536 in cash and cash equivalents, and an accumulated deficit of $54,053,503. As of the date of this prospectus, there are $585,568 in convertible notes and $76,650 in notes payable in default. The default interest rate payable for the convertible notes and the notes payable ranges between 12% and 18%. Based on our current planned operations, we expect our cash and cash equivalents, together with amounts raised in 2022 and 2023, including the proceeds from this offering, will enable us to fund our operating expenses for at least the next twenty-four months. We have based this estimate on assumptions that in the future may prove to be wrong, and we could use our capital resources sooner than we currently expect. We expect to continue to incur significant net losses for the foreseeable future.

Following this offering, we expect that our sales and marketing, R&D, regulatory and other expenses will continue to increase as we expand our marketing efforts for our diagnostic tests and services, expand existing relationships with our customers, obtain regulatory clearances or approvals for future enhancements to our existing diagnostic tests and services and conduct further clinical trials. In addition, we expect our general and administrative expenses to increase following this offering due to the additional costs associated with scaling our business operations, product development and testing capacity, particularly with respect to the expansion of our R&D operations, as well as being a public company, including due to legal, accounting, insurance, exchange listing and compliance, investor relations and other expenses. As a result, we expect to continue to incur operating losses and may never achieve profitability. We will need to generate significant additional revenue in order to achieve and sustain profitability. Even if we achieve profitability, we cannot be sure that we will remain profitable for any substantial period of time. If we do not achieve or sustain profitability, it will be more difficult for us to finance our business and accomplish our strategic objectives, either of which would have a material adverse effect on our business, financial condition and results of operations.

Even if this offering is successful, we may need additional funding in order to grow our business.

To date, we have financed our operations through private placements of our securities. We have devoted substantially all our financial resources and efforts to developing our products, workforce, and R&D capabilities. Our long-term growth and success are dependent upon our ability to generate cash from operating activities. There is no assurance that we will be able to generate sufficient cash from operations or access the capital we need to grow our business. Our inability to obtain additional capital could have a material adverse effect on our ability to fully implement our business plan as described herein and grow our business, to a greater extent than we can with our existing financial resources.

The commercial success of our in-development and future diagnostic tests and services and our revenue growth depends upon attaining significant market acceptance among payers, providers, clinics, patients, and biopharmaceutical companies.

Our commercial success depends, in part, on the acceptance of our diagnostic tests and services as being safe and relatively simple for medical personnel to learn and use, clinically flexible, operationally versatile and, with respect to providers and payers, cost effective. We cannot predict how quickly, if at all, payers, providers, clinics and patients will accept future diagnostic tests and services or, if accepted, how frequently they will be used. These constituents must believe that our diagnostic tests offer benefits over other available alternatives.

The degree of market acceptance of our in development and future diagnostic tests and services depends on a number of factors, including:

Additionally, even if our diagnostic tests achieve widespread market acceptance, they may not maintain that market acceptance over time if competing diagnostic tests or technologies, which are more cost effective or are received more favorably, are introduced. Failure to achieve or maintain market acceptance and/or market share would limit our ability to generate revenue and would have a material adverse effect on our business, financial condition and results of operations.

We experienced decreased revenues from our COVID-19 diagnostic tests in the beginning of 2022, and COVID testing revenues ultimately ceased by the end of the fourth quarter of 2022. We expect revenues from our Mitomic tests to commence in the third quarter of 2023. However, there is no assurance that our Mitomic tests will be accepted by the market, and other diagnostic tests, such as non-blood based tests, may become more accepted, produce quicker results or be more accurate. Our partners may also determine, at any time, that testing is no longer necessary and could decide to stop sending us samples for testing.

If we fail to increase our sales and marketing capabilities or develop broad awareness of our diagnostic tests in a cost-effective manner, we may not be able to generate revenue growth.

In order to generate future growth, we plan to continue to expand and leverage our account management infrastructure. Identifying and recruiting qualified account managers and training them on how to manage all partner relationships on a regional basis, on applicable federal and state laws and regulations and on our internal policies and procedures requires significant time, expense and attention. It often takes several months or more before an account manager is fully trained and productive. Our account management team may subject us to higher fixed costs than those of companies with competing techniques or diagnostic tests that utilize independent third parties, which could place us at a competitive disadvantage. It will negatively affect our business, financial condition and results of operations if our efforts to expand and train our account managers do not generate a corresponding increase in revenue, and our higher fixed costs may slow our ability to reduce costs in the face of a sudden decline in demand for our diagnostic tests. Our ability to increase our customer base and achieve broader market acceptance of our diagnostic tests will depend to a significant extent on our ability to expand our distribution efforts through our partners.

We plan to dedicate significant resources to the expansion of our distribution network and to supporting their marketing efforts. It will negatively affect our business, financial condition and results of operations if our marketing efforts and expenditures do not generate a corresponding increase in revenue. In addition, we believe that developing and maintaining broad awareness of our diagnostic tests in a cost-effective manner is critical to achieving broad acceptance of our diagnostic tests. Promotion activities may not generate patient or physician awareness or increase revenue, and even if they do, any increase in revenue may not offset the costs and expenses we incur in building our brand. If we fail to successfully promote, maintain and protect our brand, we may fail to attract or retain the physician acceptance necessary to realize a sufficient return on our brand building efforts, or to achieve the level of brand awareness that is critical for broad use of our diagnostic tests, which in turn could have a material adverse effect on our business, financial condition and results of operations.

If we cannot maintain our current relationships, or enter into new relationships, with clinical research organizations, universities, clinics or tissue banks, our revenue prospects could be reduced.

We engage contract research organizations, universities, clinics and tissue banks to enroll or access patients primarily to support clinical studies. The ability of our contractors to enroll patients in clinical studies may also fluctuate in the future, which could have a material adverse effect on our product development timelines, financial condition and results of operations. In addition, the termination of these relationships could result in a temporary or prolonged delay in commercial launches resulting in a loss of revenue.

We engage in conversations with biopharmaceutical companies regarding potential commercial opportunities on an ongoing basis. There is no assurance that any of these conversations will result in a commercial agreement, or if an agreement is reached, that the resulting relationship will be successful or that clinical or research studies conducted as part of the engagement will produce successful outcomes. Speculation in the industry about our existing or potential relationships with biopharmaceutical companies can also be a catalyst for adverse speculation about us, our tests and our technology, which can adversely affect our reputation and our business.

Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.

Our quarterly and annual revenue and operating results may fluctuate significantly, which makes it difficult for us to predict our future operating results. Our quarterly and annual operating results may fluctuate as a result of a variety of factors, many of which are outside our control and, as a result, may not fully reflect the underlying performance of our business. These fluctuations may occur due to a variety of factors, including, but not limited to:

The cumulative effects of these factors could result in large fluctuations and unpredictability in our future financial results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. Further, our historical results are not necessarily indicative of results expected for any future period, and quarterly results are not necessarily indicative of the results to be expected for the full year or any other period, and accordingly should not be relied upon as indicative of future performance.

This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any guidance we may provide, or if the guidance we provide is below the expectations of analysts or investors, the price of our Common Stock and Warrants could decline substantially. Such a stock price decline could occur even when we have met any publicly stated guidance we may provide, and could in turn negatively impact our business, financial condition and results of operations.

We need to ensure strong product performance and reliability to maintain and grow our business.

Upon reaching commercialization, we will need to maintain and continuously improve the performance and reliability of our diagnostic tests to achieve our profitability objectives. Poor product performance and reliability could lead to customer dissatisfaction, adversely affect our reputation and revenues, and increase our service and distribution costs and working capital requirements. Our diagnostic tests may contain errors or defects, and while we have made efforts to test them extensively, we cannot assure that our current diagnostic tests, or those developed in the future, will not have performance problems. Any performance issues with our diagnostic tests now or in the future will increase our costs and accordingly adversely affect our business, financial condition and results of operations.

We currently depend upon third-party suppliers and expect to depend on third party suppliers in the future, including contract manufacturers and single source suppliers, making us vulnerable to supply problems and price fluctuations.

We rely on or will rely on third-party suppliers, including in some instances single source suppliers, to provide us with components of our manufactured diagnostic tests, diagnostic test kits for clinical testing service operations and supplies for research and development. We will enter into supply agreements prior to commercial manufacture of our diagnostic test kits to minimize risk associated with such things as the potential for loss of commercial access to the product, change or modification to the product, payment terms, and shelf life or stability that could negatively affect our manufactured products. All other supplies are subject to standard purchasing terms. The number of suppliers feeding into the production of our diagnostic tests is expected to be in excess of five worldwide. We consider a select few of these suppliers, located in the United States, and Europe, as critical single source providers of components. Additionally, our Mitomic™ tests may require the use of a single blood collection tube to achieve the test performance, available from a single manufacturer in Canada (Norgen Biotek Corp). A supply agreement is being pursued with this provider. While we have initiated the second source qualification process for this critical system component, and plan to do so for all components of our manufactured diagnostic test kits, we may not be successful in securing second sourcing for any or all of them on a timely basis. We may also fail to secure terms within supply agreements to effectively mitigate all risks associated with the use of a third-party provider.

In addition, we may purchase supplies through purchase orders and may not have long-term supply agreements with, or guaranteed commitments from, many of our suppliers, including single source suppliers. Additionally, we will rely on contract manufacturers for the production of our diagnostic test. Many of our suppliers are not obligated to perform services or supply diagnostic testing materials for any specific period, in any specific quantity or at any specific price, except as may be provided in a particular purchase order. We depend on our suppliers and contract manufacturers to provide us and our partners with materials in a timely manner that meet our and their quality, quantity and cost requirements. These suppliers and contract manufacturers may encounter problems during manufacturing, delivery, or any other issue for a variety of reasons, any of which could delay or impede their ability to meet our demand. These include, but are not limited to:

Any of the foregoing may adversely and materially affect our business. And despite our continuous efforts to procure additional alternate third-party suppliers and contract manufacturers, we cannot guarantee we will find alternatives, or that we will not be affected by supply chain disruptions, shortages, and other issues.

A pandemic, epidemic or outbreak of an infectious disease in the United States or worldwide, including the outbreak of the novel strain of coronavirus disease, COVID-19, could adversely affect our business.

If a pandemic, epidemic or outbreak of an infectious disease occurs in the United States or worldwide, our business may be adversely affected. COVID-19 has spread to most countries and throughout the United States. Numerous state and local jurisdictions have imposed, and others in the future may impose, “shelter-in-place” orders, quarantines, executive orders and similar government orders and restrictions for their residents to control the spread of COVID-19. Such orders or restrictions have resulted in reduced operations at our headquarters, work stoppages, slowdowns and delays, travel restrictions and cancellation of events. Other disruptions or potential disruptions include:

Further, we cannot assure that our diagnostic tests will continue being accepted by the market or that other diagnostic tests will not become more accepted, produce quicker results or be more accurate.

As a result, the increase in revenue due to any increase in demand for these diagnostic tests may not be indicative of our future revenue. To the extent the COVID-19 pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the other risks described in this “Risk Factors” section.

The sizes of the markets for our diagnostic tests and services and any future diagnostic tests and services may be smaller than we estimate and may decline.

Our estimates of the annual total addressable market for our diagnostic tests and services are based on a number of internal and third-party estimates and assumptions, including, without limitation, the assumed prices at which we can sell our diagnostic tests and services in the market. While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors.

As a result, our estimates of the annual total addressable market for our diagnostic tests and services in different market segments may prove to be incorrect. If the actual number of patients who would benefit from our diagnostic tests, the price at which we can sell them or the annual total addressable market for them is smaller than we have estimated, it may impair our sales growth and negatively affect our business, financial condition and results of operations.

Our industry is subject to rapid change, which could make our solutions and the diagnostic tests we develop and services we offer, obsolete. If we are unable to continue to innovate and improve our diagnostic tests and services, we could lose customers or market share.

Our industry is characterized by rapid changes, including technological and scientific breakthroughs, frequent new product introductions and enhancements and evolving industry standards, all of which could make our current diagnostic tests and others we are developing obsolete. Our future success will depend on our ability to keep pace with the evolving needs of our customers on a timely and cost-effective basis and to pursue new market opportunities that develop as a result of scientific and technological advances. In recent years, there have been numerous advances in technologies relating to the diagnosis and treatment of cancer. There have also been advances in methods used to analyze very large amounts of molecular information. We must continuously enhance our offerings and develop new and improved diagnostic tests to keep pace with evolving standards of care. If we do not leverage or scale our sample and data biobank, discover new diagnostic biomarkers or applications or update our diagnostic tests to reflect new scientific knowledge, including about prostate cancer biology and other cancers in our product development pipeline, information about new cancer therapies or relevant clinical trials, our diagnostic tests could become obsolete and sales of our current diagnostic tests and any new tests we develop could decline or fail to grow as expected. This failure to make continuous improvements to our diagnostic tests to keep ahead of those of our competitors could result in the loss of customers or market share that would adversely affect our business, financial condition and results of operations. The development of new liquid biopsy technologies could negatively impact demand for our products.

Our results of operations will be materially harmed if we are unable to accurately forecast customer demand for, and utilization of, our diagnostic tests and manage our inventory.

To ensure adequate inventory supply, we must forecast inventory needs and manufacture our diagnostic tests based on our estimates of future demand for our diagnostic tests. Our ability to accurately forecast demand for them could be negatively affected by many factors, including our failure to accurately manage our expansion strategy, product introductions by competitors, an increase or decrease in customer demand for our diagnostic tests or for those of our competitors, our failure to accurately forecast customer acceptance of new diagnostic tests, unanticipated changes in general market conditions or regulatory matters and weakening of economic conditions or consumer confidence in future economic conditions. Inventory levels in excess of customer demand may result in inventory write-downs or write-offs, which would cause our gross margin to be adversely affected and could impair the strength of our brand. Conversely, if we underestimate customer demand for our diagnostic tests, our supply chain, manufacturing partners and/or internal manufacturing team may not be able to deliver components and diagnostic tests to meet our requirements, and this could result in damage to our reputation, sales growth and customer relationships. In addition, if we experience a significant increase in demand, additional supplies of raw materials or additional manufacturing capacity may not be available when required on terms that are acceptable to us, or at all, or suppliers may not be able to allocate sufficient capacity in order to meet our increased requirements, which will adversely affect our business, financial condition and results of operations.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit or halt the marketing and sale of our diagnostic tests and services. The expense and potential unavailability of insurance coverage for liabilities resulting from issues with our diagnostic tests and services could harm us and negatively impact sales.

We face an inherent risk of product liability as a result of the marketing and sale of our diagnostic tests and services. For example, we may be sued if our diagnostic tests or services cause or are perceived to cause injury or are found to be otherwise unsuitable during manufacturing, marketing or sale. Any such product liability claim may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. In addition, we may be subject to claims against us even if the apparent injury is due to the actions of others or the pre-existing health of the patient. For example, medical personnel, care partners and patients collect samples for our diagnostic tests. If these medical personnel, care partners or patients are not properly trained, are negligent or use our diagnostic tests incorrectly, the capabilities of such tests may be diminished, or the patient may suffer critical injury. We may also be subject to claims that are caused by the activities of our suppliers, such as those who provide us with components and sub-assemblies for our diagnostic tests.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or halt the marketing and sale of our diagnostic tests and services. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

We believe we have adequate product liability insurance, but it may not prove to be adequate to cover all liabilities that we may incur. Insurance coverage is increasingly expensive. We may not be able to maintain or obtain insurance at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Our insurance policy contains various exclusions, and we may be subject to a product liability claim for which we have no coverage. The potential inability to obtain sufficient product liability insurance at an acceptable cost to protect against product liability claims could prevent or inhibit the marketing and sale of our diagnostic tests and services. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts, which would have a material adverse effect on our business, financial condition and results of operations. In addition, any product liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing coverage, harm our reputation in the industry, significantly increase our expenses and reduce product sales.

We face competition from many sources, including larger companies, and we may be unable to compete successfully.

There are a number of diagnostic solutions companies in the United States, Europe and Asia. Notable competitors in the United States include, but are not limited to, Opko Health, Inc., MDxHealth, and Exosome Diagnostics, Inc. These competitors all provide diagnostic tests to hospitals, researchers, clinicians, laboratories and other medical facilities. Many of these organizations are significantly larger with greater financial and personnel resources than us, and enjoy significantly greater market share and have greater resources than we do. As a consequence, they may be able to spend more on product development, marketing, sales and other product initiatives than we can. Some of our competitors have:

Our continued success depends on our ability to:

As we attain greater commercial success, our competitors are likely to develop diagnostic tests that offer features and functionality similar to our diagnostic tests that are currently on the market. Improvements in existing competitive diagnostic tests or the introduction of new competitive diagnostic tests may make it more difficult for us to compete for sales, particularly if those competitive diagnostic tests demonstrate better reliability, convenience or effectiveness or are offered at lower prices.

Performance issues, service interruptions or price increases by our shipping carriers and warehousing providers could adversely affect our business and harm our reputation and ability to provide our services on a timely basis.

Expedited, reliable shipping and delivery services and secure warehousing are essential to our operations. We rely heavily on providers of transport services for reliable and secure point-to-point transport of our diagnostic tests to our customers and for tracking of these shipments, and from time to time require warehousing for our diagnostic tests, sample collection kits and supplies. Should a carrier encounter delivery performance issues such as loss, damage or destruction of any systems, it would be costly to replace such systems in a timely manner and such occurrences may damage our reputation and lead to decreased demand for our diagnostic tests and increased cost and expense to our business. In addition, any significant increase in shipping or warehousing rates could adversely affect our operating margins and results of operations. Similarly, strikes, severe weather, natural disasters, civil unrest and disturbances or other service interruptions affecting delivery or warehousing services we use would adversely affect our ability to process orders for our diagnostic tests on a timely basis. For instance, the COVID-19 pandemic has caused supply chain and shipping and delivery services delays, which has affected our ability to timely deliver our diagnostics tests, sample collection kits and supplies in some cases.

We rely on commercial courier delivery services to transport samples to our laboratory facility in a timely and cost-efficient manner and if these delivery services are disrupted, our business will be harmed. Disruptions in delivery service, whether due to labor disruptions, bad weather, natural disaster, civil unrest or disturbances, terrorist acts or threats or for other reasons could adversely affect specimen integrity and our ability to process samples in a timely manner and to service our customers, and ultimately our reputation and our business. In addition, if we are unable to continue to obtain expedited delivery services on commercially reasonable terms, our operating results may be adversely affected.

Cost-containment efforts of our customers, purchasing groups and governmental purchasing organizations could have a material adverse effect on our future sales and profitability.

In an effort to reduce costs, many hospitals in the United States have become members of GPOs and Integrated Delivery Networks (IDNs). GPOs and IDNs negotiate pricing arrangements with medical device companies and distributors and then offer these negotiated prices to affiliated hospitals and other members. GPOs and IDNs typically award contracts on a category-by-category basis through a competitive bidding process. Bids are generally solicited from multiple providers with the intention of driving down pricing or reducing the number of vendors. Due to the highly competitive nature of the GPO and IDN contracting processes, we may not be able to obtain new contract positions with major GPOs and IDNs. Furthermore, the increasing leverage of organized buying groups may reduce market prices for our diagnostic tests, thereby reducing our revenue and margins.

While having a contract with a GPO or IDN for a given product category can facilitate sales to members of that GPO or IDN, such contract positions can offer no assurance that any level of sales will be achieved, as sales are typically made pursuant to individual purchase orders. Even when a provider is the sole contracted supplier of a GPO or IDN for a certain product category, members of the GPO or IDN are generally free to purchase from other suppliers. Furthermore, GPO and IDN contracts typically are terminable without cause by the GPO or IDN upon 60 to 90 days’ notice. Accordingly, the members of such groups may choose to purchase alternative diagnostic tests due to the price or quality offered by other companies, which could result in a decline in our revenue.

We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our success.

We are highly dependent on our senior management and other key personnel. Our success will depend on our ability to retain senior management and to attract and retain qualified personnel in the future, including sales and marketing professionals, scientists, clinical specialists, and other highly skilled personnel and to integrate current and additional personnel in all departments. The loss of members of our senior management, sales and marketing professionals, scientists, clinical and regulatory specialists could result in delays in product development and harm our business. If we are not successful in attracting and retaining highly qualified personnel, it would have a material adverse effect on our business, financial condition and results of operations.

Our research and development programs and laboratory operations depend on our ability to attract and retain highly skilled scientists and technicians. We may not be able to attract or retain qualified scientists and technicians in the future due to the competition for qualified personnel among life science businesses, particularly near our headquarters in West Palm Beach, FL, United States and our laboratory facility in Newcastle upon Tyne, UK. We also face competition from universities and public and private research institutions in recruiting and retaining highly qualified scientific personnel.

We may also have difficulties locating, recruiting or retaining qualified salespeople. Recruiting and retention difficulties can limit our ability to support our research and development and sales programs. To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have issued and may continue to issue equity awards that vest over time. Our employment arrangements with our employees provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice, which may lead to more difficulty in retaining qualified salespeople and other talent.

We will need to raise additional capital to fund our existing operations, develop our platform, commercialize new diagnostic tests or expand our operations.

We will need to raise additional capital in the future to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons, including to:

Our present and future funding requirements will depend on many factors, including:

The various ways we could raise additional capital carry potential risks. If we raise funds by issuing equity securities, our stockholders could experience dilution. Any preferred equity securities issued also could provide for rights, preferences or privileges senior to those of holders of our Common Stock. If we raise funds by issuing debt securities, those debt securities would have rights, preferences and privileges senior to those of holders of our Common Stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to our platform technologies or diagnostic tests, pay a portion of our royalties, or grant licenses on terms that are not favorable to us.

Our financial statements contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern, which could prevent us from obtaining new financing on reasonable terms or at all.

We have incurred substantial operating losses since inception and expect to continue to incur significant operating losses for the foreseeable future. As of December 31, 2022, we had an accumulated deficit of $54,053,503. The Company has incurred recurring losses and the Company expects to continue to incur losses as a result of costs and expenses related to the Company’s clinical development and corporate general and administrative activities. We had a working capital deficit of $26,311,952 as of December 31, 2022. Our financial statements have been prepared assuming that we will continue as a going concern. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

This going concern opinion could materially limit our ability to raise additional funds through the issuance of equity or debt securities or otherwise. Further financial statements may include an explanatory paragraph with respect to our ability to continue as a going concern. Until we can generate significant recurring revenues, we expect to satisfy our future cash needs through debt or equity financing. If funds are not available, we may be required to delay, reduce the scope of, or eliminate research or development plans for, or commercialization efforts with respect to our products. This raises substantial doubts about our ability to continue as a going concern.

If we are unable to continue as a going concern, our securities will have little or no value.

Although our audited financial statements for the years ended September 30, 2022 and 2021 were prepared under the assumption that we would continue our operations as a going concern, the report of our independent registered public accounting firm that accompanies our financial statements for the years ended September 30, 2022 and 2021 contains a going concern assessment from our management on the substantial doubt about our ability to continue as a going concern, based on the financial statements at that time. Specifically, we have sustained recurring losses and we have had working capital and stockholders’ equity deficits. These prior losses and expected future losses have had, and will continue to have, an adverse effect on our financial condition. In addition, continued operations and our ability to continue as a going concern may be dependent on our ability to obtain additional financing in the near future and thereafter, and there are no assurances that such financing will be available to us at all or will be available in sufficient amounts or on reasonable terms. Our financial statements do not include any adjustments that may result from the outcome of this uncertainty. If we are unable to generate additional funds in the future through sales of our products, financings or from other sources or transactions, we will exhaust our resources and will be unable to continue operations. If we cannot continue as a going concern, our shareholders would likely lose most or all of their investment in us. The ability of the Company to continue as a going concern is dependent upon its ability to successfully execute the business plan and attain profitable operations.

Our future collaborations may be important to our business. If we are unable to maintain any of these collaborations, or if these collaborations are not successful, our business could be adversely affected.

We have limited capabilities for technology development, sales, marketing or distribution. Accordingly, we may enter into collaborations with academic and commercial entities to provide us with important technologies and funding for our programs and technology, and we may receive additional technologies and funding under these and other collaborations in the future. Any future collaborations we enter into may pose a number of risks, including the following:

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If our potential future collaborations do not result in the successful discovery, development and commercialization of products or if one of our collaborators terminates its agreement with us, we may not receive any future research funding or milestone potential payments under the collaboration. If we do not receive the funding we expect under these agreements, our development of our technology and applications could be delayed and we may need additional resources to develop products and our technology. All of the risks relating to product development, regulatory approval and commercialization described in this prospectus also apply to the activities of our collaborators.​

Additionally, if one of our potential future collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators and our perception in the business and financial communities could be adversely affected.

The timing of our new product offerings is uncertain.

We have multiple products in various phases of development, and we intend to devote considerable future resources to research and product development, our core business strategy. There can be no assurance that our development activities will always produce tests with the sensitivity and specificity necessary to be clinically and commercially competitive, or that any test will result in a commercially successful product. In addition, before we can develop diagnostic tests for new cancers or other diseases and commercialize any new products, we will need to:

Our product development process involves a high degree of risk and may take several years in some instances. Our product development efforts may fail for many reasons, including, but not limited to:

Few research and development projects result in commercial products, and success in early clinical trials often is not replicated in later studies. At any point, we may abandon development of a product candidate, or we may be required to expend considerable resources repeating clinical trials, which would adversely impact the timing for generating potential revenues from those product candidates. In addition, as we develop products, we will have to make significant investments in product development. If a clinical validation study fails to demonstrate the prospectively defined endpoints of the study, we might choose to abandon the development of the product or product feature that was the subject of the clinical trial, which could harm its business. In addition, our competitors may develop and commercialize competing products faster than we are able to do so.

Our access to samples may hinder our ability to research, develop, and commercialize future products.

Our planned and future products are focused primarily on exploitation of blood plasma as a medium for both biomarker identification and validation and ultimately for our commercial testing applications. Our clinical development relies on our ability to secure access to high quality, well-characterized samples, as well as information pertaining to the samples associated clinical outcomes. Our competitors have demonstrated their ability to obtain these samples and often compete with us for access to such samples. Additionally, the process of negotiating access to samples is lengthy since it typically involves numerous parties and approval levels to resolve complex issues such as usage rights, institutional review board approval, privacy rights, publication rights, intellectual property ownership and research parameters. If we are not able to negotiate access to samples with hospitals, clinical partners, or other companies on a timely basis, or at all, or if competitors secure access to these samples before us, then our ability to research, develop, and commercialize future products will be limited or delayed.

We depend on distributors for our sales.

We have limited experience marketing and selling our diagnostic tests. We will rely on our network of licensees and distributors to sell our diagnostic tests globally, and any failure to maintain and grow our distribution network will negatively affect our business, financial condition and results of operations. Our distribution partners are highly trained and possess substantial technical expertise, which we believe is critical in increasing adoption of our diagnostic tests in their respective territories. The loss of these business partners to competitors, or otherwise, will negatively affect our business, financial condition and results of operations. If we are unable to retain our distributors or replace them with partners of equivalent technical expertise, qualifications, and track-records, it may negatively affect our business, financial condition and results of operations. There are no financial penalties if our distribution partners choose to discontinue our products.

We currently maintain distribution agreements for our two planned products – the Mitomic Prostate Test (or MPT™) and the Mitomic Endometriosis Test (or MET™) – in many countries across the world. We may enter into other similar arrangements to distribute our products in the same countries or other countries in the future. We intend to grow our business, and to do so we may need to attract additional distributors to expand the territories in which we intend to sell our planned and future products. Distributors may not commit the necessary resources to market and sell our products to the level of our expectations. If current or future distributors do not perform adequately, or we are unable to enter into arrangements with distributors in particular geographic areas, we may not realize long-term revenue growth. In addition, our revenue from distributors could be negatively impacted as a result of changes in business cycles, business conditions or other factors that could affect the third-party distributor’s ability or willingness to market our products. Regulatory requirements, costs of doing business outside of the United States and the reimbursement process in foreign markets may also impact our revenues from international sales or impact our ability to increase international sales in the future. Our distribution contracts do not contain revenue guarantees. If distributors fail to purchase the contractual amounts of our products there will be no penalties due us or legal recourse other than termination of the agreement or loss of market exclusivity in some cases.

Furthermore, our success depends on third-party distribution and these distributors’ ability to attract and retain salespeople with extensive experience selling products in oncology, urology, gynecology, and medical disciplines. We may have difficulties developing sales if we and/or our third-party distributors have difficulty locating, recruiting or retaining qualified salespeople, which could cause a delay or decline in the rate of adoption of our tests.

Adherence to complex test protocols is required.

We validate our tests in our lab in the UK using blood samples obtained from a variety of sources. Tests results can be affected by a number of variables including how the blood is extracted, how the blood is handled, the type of test tube used, the number and speed of centrifuge spins, the temperature the blood is exposed to during processing, the concentration of the reagents, and the timing of reagent use. All of these and other variables in the process are set forth in an assay protocol that we provide to our distributor lab partners along with training in proper compliance. If, due to human or equipment failure, there is material deviation from the protocols, the accuracy of our tests can be negatively impacted. If that occurs, the reputation of our products and our revenue could be negatively impacted.

The UK departure from the European Union (EU) could adversely affect us.

We sell our products and services in the UK and throughout Europe. The UK withdrew from the EU on January 31, 2020, otherwise known as “Brexit.” Effective January 1, 2021, the EU and UK entered into the Trade and Cooperation Agreement regarding trade policies and other political and strategic issues. The future consequences of Brexit are unknown at this time, but Brexit has created additional administrative burden and legal, regulatory, and currency risk that may have a materially adverse impact on our business. Furthermore, this uncertainty could negatively impact the economies of other countries in which we operate.

Risks Related to our Governmental Regulation

The insurance coverage and reimbursement status of newly approved diagnostic tests, particularly in a new category of diagnostics, is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for in-development or future diagnostic tests could limit our ability, and that of our collaborators, to fully commercialize our diagnostic tests and decrease our ability to generate revenue.

The availability and extent of reimbursement by governmental and private payers is essential for most patients to be able to afford the clinical diagnostic tests that we currently or in the future plan to develop and sell. In addition, because our clinical diagnostics and diagnostic tests represent new approaches to the research, diagnosis, detection and treatment of diseases, we cannot accurately estimate how our diagnostic tests, and those jointly created with our collaborators, would be priced, whether reimbursement could be obtained, or any potential revenue generated. Sales of our diagnostic tests will depend substantially, both domestically and internationally, on the extent to which the costs of our diagnostic tests are paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third-party payers. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize some of our diagnostic tests or services. Even if coverage is provided, the available reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize an adequate return on our investment in any of our diagnostic tests or services. Changes in the reimbursement landscape may occur, which are outside of our control, and may impact the commercial viability of our diagnostic tests.

In the United States, many significant decisions about reimbursement for new diagnostics and medicines are typically made by the Centers for Medicare and Medicaid Services (“CMS”), an agency within the Department of Health and Human Services (“HHS”). CMS decides whether and to what extent a new diagnostic or medicine will be covered and reimbursed under Medicare, although it frequently delegates this authority to local Medicare Administrative Contractors. Private payers tend to follow Medicare to a substantial degree. It is difficult to predict what CMS will decide with respect to reimbursement for novel diagnostic tests such as ours. Additionally, reimbursement agencies in Europe may be more conservative than CMS. For example, a number of cancer drugs have been approved for reimbursement in the United States and have not been approved for reimbursement, or have been approved under restricted conditions, in certain European countries.

Outside the United States, the reimbursement process and timelines vary significantly. Certain countries, including a number of member states of the EU, set prices and make reimbursement decisions for diagnostics and pharmaceutical products, or medicinal products, as they are commonly referred to in the EU, with limited participation from the marketing authorization or CE mark holders, or may take decisions that are unfavorable to the authorization or CE mark holder where they have participated in the process. We cannot be sure that such prices and reimbursement decisions will be acceptable to us or our collaborators. If the regulatory authorities in these foreign jurisdictions set prices or make reimbursement criteria that are not commercially attractive for us or our collaborators, our revenues and the potential profitability of our products in those countries would be negatively affected. In many countries, the pricing review period begins after marketing or product licensing approval is granted or the CE mark is obtained. As a result, we or our collaborators might obtain marketing approval for a product or service in a particular country, but then may experience delays in the reimbursement approval or be subject to price regulations that would delay the commercial launch of our product or service, possibly for lengthy time periods, which could negatively impact the revenues we are able to generate from the sale of that product or service in that particular country.

Moreover, increasing efforts by governmental and third-party payers, in the United States and abroad, to cap or reduce healthcare costs may cause such organizations to limit both coverage and level of reimbursement for newly cleared, authorized or approved devices and medicines and, as a result, they may not cover or provide adequate payment for our clinical diagnostics to be sold by us or our collaborators. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, which are, in some cases, designed to encourage importation from other countries and bulk purchasing.

We expect to experience pricing pressures on our clinical diagnostics sold by us and our collaborators due to the trend toward value-based pricing and coverage, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new diagnostic tests.

Measures to reduce healthcare costs may hurt our business.

The majority of our future customers are healthcare providers who depend upon reimbursement by government and commercial insurance payers for molecular diagnostic solutions services. With a vast majority of United States patients with various cancers covered by Medicare, the Medicare reimbursement rate is an important factor in a customer’s decision to use our diagnostic tests and limits the prices we may charge for them. Commercial insurance payers may also exert downward pressure on payment rates for cancer treatment services. A reduction in reimbursement rates for cancer treatments may adversely affect our customers’ businesses and cause them to enact cost reduction measures that may include reducing the scope of their programs, thereby potentially reducing demand for our diagnostic tests.

Healthcare reform measures could hinder or prevent the commercial success of our diagnostic tests.

In the United States, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system in ways that may harm our future revenues and profitability and the demand for our diagnostic tests. Federal and state lawmakers regularly propose and, at times, enact legislation that would result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. Current and future legislative proposals to further reform healthcare or reduce healthcare costs may limit coverage of or lower reimbursement for the procedures associated with the use of our diagnostic tests.

The effect of any healthcare reform initiative implemented in the future could impact our revenue from the sale of our diagnostic tests. For example, the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “ACA”), contains a number of provisions, including those governing enrollments in federal healthcare programs, reimbursement changes and fraud and abuse measures, all of which will impact existing government healthcare programs and will result in the development of new programs.

There have been judicial challenges to certain aspects of the ACA, as well as efforts by Congress to repeal, replace or alter the implementation of certain aspects of the ACA. Most recently, the Supreme Court of the United States granted certiorari on March 2, 2020, for a Texas District Court case, which invalidated the ACA in its entirety because he concluded that the individual mandate was unconstitutional. Although the Supreme Court of the United States reversed the holding and remanded the case back to the Texas District Court, it is unclear how the Texas District Court will rule, as it is unclear how any future decisions, subsequent appeals, and other efforts to challenge, repeal, or replace, or alter the implementation of the ACA will affect our business, financial condition and results of operations.

Congress may continue to pursue significant changes to the current healthcare laws. We face uncertainties that might result from modifications or repeal of any of the provisions of the ACA, including as a result of current and future executive orders and legislative actions. The impact of those changes on us and potential effect on the medical device industry as a whole is currently unknown. Any changes to the ACA are likely to have an impact on our results of operations, and may negatively affect our business, financial condition and results of operations. We cannot predict what other healthcare programs and regulations will ultimately be implemented at the federal or state level or the effect of any future legislation or regulation in the United States on our business, financial condition and results of operations.

The continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce costs of healthcare may harm:

The ACA substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacts our industry. Future changes in healthcare policy could increase our costs and subject us to additional regulatory requirements that may interrupt commercialization of our current and future solutions. Future changes in healthcare policy could also decrease our revenue and impact sales of and reimbursement for our in-development and future diagnostic tests.

We must comply with healthcare fraud and abuse laws.

Various federal and state laws, as well as the laws of foreign countries, prohibit payments to induce the referral, purchase, order or use of healthcare products or services and require medical device companies to limit prevent, and/or monitor, and report certain payments to third-party payers, health care professionals, and other individuals. These healthcare fraud and abuse anti-kickback, public reporting and aggregate spend laws affect our sales, marketing and other promotional activities by limiting the kinds of financial arrangements, including sales programs, we may have with cancer treatment providers, hospitals, physicians or other potential purchasers or users, including patients, of medical devices and services. In particular, these laws influence, among other things, how we structure our sales offerings, including discount practices, customer support, education and training programs and physician consulting and other service arrangements. These laws prohibit certain marketing initiatives that are commonplace in other industries. If we were to offer or pay inappropriate inducements for the purchase, order or use of our diagnostic tests or our services, or our arrangements are perceived as inappropriate inducements, we could be subject to claims under various healthcare fraud and abuse laws.

Restrictions under applicable United States federal and state healthcare laws and regulations include the following:

Other federal and state laws, as well as the laws of foreign countries, generally prohibit individuals or entities from knowingly presenting, or causing to be presented, claims for payments to government or commercial payers that are false or fraudulent, or for items or services that were not provided as claimed. Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of product candidates and medical devices from government-funded healthcare programs, such as Medicare and Medicaid, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations. Moreover, any investigation into our practices could cause adverse publicity and require a costly and time-consuming response. If any physicians or other healthcare providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government-funded healthcare programs.

Manufacturers can also be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by providing inaccurate billing or coding information to customers, by providing improper financial inducements, or through certain other activities. We attempt to ensure that any billing and coding information we provide for our diagnostic tests emphasizes the need for physicians and other providers to make independent judgments, use accurate and appropriate billing and coding that complies with all applicable payer policies, and document the medical need for their patients as appropriate. Nevertheless, the government may not regard any billing errors that may be made by our customers as inadvertent and may examine our role in providing information to our customers, physicians and patients concerning the benefits and potential coverage of more frequent therapy.

The regulatory clearance or approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming, and unpredictable. If we are ultimately unable to obtain any necessary or desirable regulatory approvals or clearances, or if such approvals or clearances are significantly delayed, our business will be substantially harmed.

The time required and ability to obtain clearance or approval by the FDA and comparable foreign regulatory authorities is unpredictable, typically takes several years following the commencement of clinical studies, and depends upon numerous factors, including the type, complexity, and novelty of our products. In addition, policies, laws, regulations, or the type and amount of clinical data necessary to gain clearance or approval may change during the course of a test’s clinical development and may vary among jurisdictions, which may cause delays in the clearance or approval of, or the decision not to approve, an application. Regulatory authorities have substantial discretion in the premarket review process and may refuse to accept any application, decide that our data are insufficient for clearance or approval, require additional clinical or other data, or determine that our manufacturing and quality systems are insufficient or in violation of applicable requirements. Even if we believe our data are sufficient to support regulatory approval, regulatory authorities may disagree that approval is warranted, or may require the generation and submission of additional data or data analyses and significantly delay approval.

Before a new medical device, or a new intended use of, claim for, or significant modification to an existing device, can be marketed in the United States, a company must first submit an application for and receive 510(k) clearance pursuant to a premarket notification submitted under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), de-novo classification, or “PMA” approval from the FDA, unless an exemption applies. Products that are approved through a PMA application generally need prior FDA approval before modifications can be made that affect safety or effectiveness, and certain modifications to a 510(k)-cleared device may also require FDA premarket review before the modified product can be marketed. We have not applied for regulatory clearance or approval for any of our products, and it is possible that we will never obtain regulatory clearance or approval.

FDA or other regulators can delay, limit, or deny premarket clearance or approval of a product for many reasons, including but not limited to the following:

FDA regulation of our industry generally or our tests specifically could be disruptive to our business.

Our operations are subject to extensive federal, state, local and foreign laws and regulations, including FDA laws and regulations, all of which are subject to change. These laws and regulations are complex and are subject to interpretation by the courts and by government agencies. We believe that we are in material compliance with all statutory and regulatory requirements applicable to us, but there is a risk that one or more government agencies could take a contrary position, or that a private party could file suit under the qui tam provisions of the federal False Claims Act or a similar state law. Such occurrences, regardless of their outcome, could damage our reputation and adversely affect important business relationships with third parties, including managed care organizations, and other private third-party payers.

In the United States, before we can market a new medical device, or a new use of, or claim for, an existing product, we must first receive either 510(k) clearance, PMA approval or approval of a de-novo application from the FDA, unless an exemption applies.

Government regulation of medical devices is meant to assure their safety and effectiveness, and includes regulation of, among other things:

Ÿ design, development and manufacturing;

Ÿtesting, labeling, including directions for use, processes, controls, quality assurance, packaging, storage, distribution, installation and servicing;

Ÿpre-clinical studies and clinical trials;

Ÿ establishment registration and listing;

Ÿtest kit safety and effectiveness;

Ÿmarketing, sales and distribution;

Ÿrecordkeeping procedures;

Ÿ advertising and promotion;

Ÿpremarket authorization (510(k), PMA, de-novo, Emergency Use Authorization (EUA));

Ÿcorrections and removals and recalls;

Ÿ post-market surveillance, including reporting of deaths or serious injuries, and malfunctions that, if they were to recur, would be likely to cause or contribute to a death or serious injury; and

Ÿproduct import and export.

The FDA has recently increased its attention to marketing of pharmacogenetic tests. For example, in late 2018, the FDA issued a safety communication regarding genetic laboratory tests marketed directly to consumers or offered through health care providers with claims to predict a patient’s response to specific medications, based on their not having been reviewed by the FDA and potentially not being supported by clinical evidence. Among other tests, the FDA notice cited genetic tests that claim results can be used to help physicians identify which antidepressant medication would have increased effectiveness or side effects compared to other antidepressant medications. As explained by the FDA in its update to this safety communication, the FDA sent notices to several firms marketing such pharmacogenetic tests where the FDA believes the relationship between genetic variations and the medication’s effects has not been established. This included a Warning Letter issued in 2019 to the manufacturer of several genetic tests which had not been reviewed by the FDA for safety and effectiveness. This is an area of high FDA scrutiny based on the perceived public health risk of consumers relying on inadequately substantiated claims to guide treatment decisions.

We can provide no assurances that the FDA will not focus its attention on diagnostic tests, including those that we provide. If this were to happen, it may impact our marketing practices relating to the relevant tests, which in turn may have an adverse impact on our business, financial condition and results of operations.

Failure to comply with federal, state and foreign laboratory licensing requirements and the applicable requirements of the FDA or any other regulatory authority, could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial sanctions.

The diagnostic testing industry is subject to extensive laws and regulations, many of which have not been interpreted by the courts, including the application of the FDA’s Emergency Use Authorization (EUA) authority.

Our US lab partners are also subject to CLIA, a federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. CLIA requires virtually all laboratories to be certified by the federal government and mandates compliance with various operational, personnel, facilities administration, quality and proficiency testing requirements intended to ensure that testing services are accurate, reliable and timely. CLIA certification is also a prerequisite to be eligible to bill state and federal health care programs, as well as many private third-party payers, for laboratory testing services. As a condition of CLIA certification, each of our laboratories is subject to survey and inspection every other year, in addition to being subject to additional random inspections. The biennial survey is conducted by CMS, a CMS agent (typically a state agency), or, if the laboratory holds a CLIA certificate of accreditation, a CMS-approved accreditation organization. Sanctions for failure to comply with CLIA requirements, including proficiency testing violations, may include suspension, revocation, or limitation of a laboratory’s CLIA certificate, which is necessary to conduct our business, as well as the imposition of significant fines or criminal penalties.

Any sanction imposed under CLIA, its implementing regulations, or state or foreign laws or regulations governing licensure, or our failure to renew a CLIA certificate, a state or foreign license, or accreditation, could have a material adverse effect on our business. If the CLIA certificate of any one of our laboratories is revoked, CMS could seek revocation of the CLIA certificates of our other laboratories based on their common ownership or operation, even though they are separately certified.

We may also be subject to regulation in foreign jurisdictions as we seek to expand international utilization of our tests or such jurisdictions adopt new licensure requirements, which may require review of our tests in order to offer them or may have other limitations that may limit our ability to make our tests available outside of the United States. Complying with licensure requirements in new jurisdictions may be expensive, time-consuming and subject us to significant and unanticipated delays. Changes in state or foreign licensure laws that affect our ability to offer and provide diagnostic services across state or foreign country lines could materially and adversely affect our business. In addition, state and foreign requirements for laboratory certification may be costly or difficult to meet and could affect our ability to receive specimens from certain states or foreign countries.

Failure to comply with applicable clinical laboratory licensure requirements may result in a range of enforcement actions, including suspension, limitation or revocation of our CLIA certificate and/or state licenses, imposition of a directed plan of action, onsite monitoring, civil monetary penalties, criminal sanctions and revocation of the laboratory’s approval to receive Medicare and Medicaid payment for its services, as well as significant adverse publicity. Any sanction imposed under CLIA, its implementing regulations, or state or foreign laws or regulations governing clinical laboratory licensure or our failure to renew our CLIA certificate, a state or foreign license or accreditation, could have a material adverse effect on our business, financial condition and results of operations. Even if we were able to bring our laboratory back into compliance, we could incur significant expenses and potentially lose revenue in doing so.

Changes in the way that the FDA regulates tests performed by laboratories like ours could result in delay or additional expense in offering our tests and tests that we may develop in the future.

We intend to sell several of our products as laboratory developed tests (“LDTs”). LDTs are in vitro diagnostic tests that are intended for clinical use and are designed, manufactured, and used within a single laboratory. Although LDTs are classified as medical devices and the FDA has statutory authority to ensure that medical devices are safe and effective for their intended uses, the FDA has historically exercised enforcement discretion and has not enforced certain otherwise applicable medical device requirements with respect to LDTs (e.g., establishment registration, device listing, quality systems regulations, premarket clearance or approval, and post-market controls).

Legislative proposals addressing the FDA’s oversight of LDTs have been previously introduced, and we expect that new legislative proposals will be introduced from time to time. The likelihood that Congress will pass such legislation and the extent to which such legislation may affect the FDA’s plans to regulate LDTs as medical devices is difficult to predict. In March 2020, the Verified Innovative Testing in American Laboratories (“VITAL”) Act of 2020 was introduced in the Senate, which would expressly shift the regulation of LDTs from FDA to CMS. If VITAL or a similar statute were to be enacted, it could mean that the FDA regulatory burden would decrease; however, it could also potentially result in new CMS requirements for LDTs. Moreover, if additional changes occur in the current requirements for LDTs, we may lose the ability to commercialize our tests without FDA premarket clearance or approval, which would require us to incur substantial costs and delays in offering our tests and tests that we may develop in the future and subject such tests to additional regulatory requirements.

Moreover, even if it does not modify its policy of enforcement discretion, the FDA may disagree that we are marketing our LDTs within the scope of this policy and may impose significant regulatory requirements or take enforcement actions. The FDA may request that we provide additional analyses and information beyond that which we intend to produce based on the designs of our current and planned clinical studies, or that we modify or narrow our intended use or product claims. A delay in the launch of our products, or significantly narrowing their intended uses, could negatively impact our revenues, financial condition, business, prospects, and/or results of operations.

If premarket review is required for some or all of our products, the FDA may require that we stop selling our products pending clearance or approval, which would negatively impact our business. Even if our products are allowed to remain on the market prior to required clearance or approval, demand or reimbursement for our products may decline if there is uncertainty about our products, if we are required to label our products as investigational by the FDA, or if the FDA limits the labeling claims we are permitted to make for our products. As a result, we could experience significantly increased development costs and a delay in generating additional revenue from our products, or from other products now in development.

Finally, if the FDA asserts active regulatory authority over our products (i.e., determines them ineligible for the enforcement discretion), we will need to implement all of the required post-market controls for regulated medical devices including compliance with all applicable provisions of the FDA’s Quality System Regulation (“QSR”), medical device reporting, corrections and removals, etc.

Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of any future diagnostic tests and to manufacture, market and distribute our diagnostic tests after clearance or approval is obtained.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing of regulated products or the reimbursement thereof. For example, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act recently introduced in Congress would codify into law the term “in vitro clinical test” (IVCT) in order to create a new medical product category separate from medical devices that would include products currently regulated as in vitro diagnostics as well as LDTs. It would establish a risk-based approach to imposing requirements on in vitro tests, including LDTs, related to premarket review, quality systems, and labeling requirements. Depending on the approach adopted under any potential legislation, certain LDTs (likely those of higher risk) may be required to undergo some form of premarket review, potentially with a transition period for compliance and a grandfathering provision.

In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our diagnostic tests. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of planned or future diagnostic tests. It is impossible to predict whether legislative changes will be enacted or FDA regulations, guidance or interpretations changed, and what the impact of such changes, if any, may be.

Any change in the laws or regulations that govern the clearance and approval processes relating to our current, planned and future diagnostic tests could make it more difficult and costly to obtain clearance or approval for new diagnostic tests or to produce, market and distribute existing diagnostic tests. Significant delays in receiving clearance or approval or the failure to receive clearance or approval for any new diagnostic tests would have an adverse effect on our ability to expand our business.

Any product for which we obtain regulatory clearance or approval will be subject to extensive ongoing regulatory requirements, and we may be subject to penalties if we or our partners fail to comply with regulatory requirements or if we experience unanticipated problems with our products.

Any product for which we obtain regulatory clearance or approval from the FDA or other regulators, along with the manufacturing processes, post-market surveillance, labeling, packaging, advertising, and promotion, distribution, storage, import, export, reporting, and recordkeeping for such product, will be subject to continued regulatory review, oversight, requirements, and periodic inspections by the FDA and comparable foreign regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports; registration and listing requirements; requirements relating to quality control, quality assurance, and corresponding maintenance of records and documents; requirements relating to recalls, removals, and corrections; and requirements relating to product labeling, advertising and promotion, and recordkeeping. The regulations to which we are subject are complex and have tended to become more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales. The FDA enforces these regulatory requirements through, among other means, periodic unannounced inspections. We do not know whether we will be found compliant in connection with any future regulatory inspections.

Regulatory clearance or approval of a test or device may be subject to limitations by the regulatory body as to the indicated uses for which the product may be marketed or to other conditions of clearance or approval. In addition, clearance or approval may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the test or device. After clearance or approval, discovery of problems with our product, suppliers, vendors, or contract manufacturers, or manufacturing processes (including software validation), and/or failure to comply with regulatory requirements, may result in actions such as:

For any of our products that are approved or cleared by the FDA, we will be required to report to the FDA certain information about adverse medical events or malfunctions, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.

For products for which we obtain FDA clearance or approval, we will be subject to the FDA’s medical device reporting regulations and similar foreign regulations, which require us to report to the FDA when we receive or become aware of information that reasonably suggests that one or more of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury. The timing of our obligation to report is triggered by the date we become aware of the adverse event as well as the nature of the event. We may fail to report adverse events of which we become aware within the prescribed timeframe. We may also fail to recognize that we have become aware of a reportable adverse event, especially if it is not reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the product. If we fail to comply with our reporting obligations, the FDA could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device clearance or approval, seizure of our products, or delay in clearance or approval of future products.

The FDA and foreign regulatory bodies have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture of a product or in the event that a product poses an unacceptable risk to health. The FDA’s authority to require a recall must be based on a finding that there is reasonable probability that the device could cause serious injury or death. We may also choose to voluntarily recall a product if any material deficiency is found. A government-mandated or voluntary recall by us could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling or design deficiencies, packaging defects or other deficiencies or failures to comply with applicable regulations. Product defects or other errors may occur in the future. Depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA may require, or we may decide, that we will need to obtain new clearances or approvals for the device before we may market or distribute the corrected device. Seeking such clearances or approvals may delay our ability to replace the recalled devices in a timely manner. Moreover, if we do not adequately address problems associated with our devices, we may face additional regulatory enforcement action, including FDA Warning letters, product seizure, injunctions, administrative penalties or civil or criminal fines.

Companies are required to maintain certain records of recalls and corrections, even if they are not reportable to the FDA. We may initiate voluntary withdrawals or corrections for our products in the future that we determine do not require notification of the FDA. If the FDA disagrees with our determinations, it could require us to report those actions as recalls and we may be subject to enforcement action. A future recall announcement could harm our reputation with customers, potentially lead to product liability claims against us and negatively affect our sales. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business and may harm our reputation and financial results.

To obtain and maintain FDA approvals or clearances, our products will need to be manufactured in accordance with federal and state regulations, and we could be forced to recall our devices or terminate production if we or our partners fail to comply with these regulations.

If our products are actively regulated as medical devices (as opposed to falling under the LDT enforcement discretion), the methods used in, and the facilities used for, their manufacture must comply with the QSR a complex regulatory scheme that covers the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution, installation, servicing and shipping of medical devices. Furthermore, we will be required in that case to verify that our suppliers maintain facilities, procedures and operations that comply with our quality standards and applicable regulatory requirements. The FDA enforces the QSR through periodic announced or unannounced inspections of medical device manufacturing facilities, which may include the facilities of subcontractors. Our products are also subject to similar state regulations and various laws and regulations of foreign countries governing manufacturing.

Our third-party manufacturers may not take the necessary steps to comply with applicable regulations, which could cause delays in the delivery of our products. In addition, failure to comply with applicable FDA requirements or later discovery of previously unknown problems with our products or manufacturing processes could result in, among other things: Warning letters or Untitled letters; fines, injunctions or civil penalties; suspension or withdrawal of approvals; seizures or recalls of our products; total or partial suspension of production or distribution; administrative or judicially imposed sanctions; FDA refusal to grant pending or future clearances or approvals for our products; clinical holds; refusal to permit the import or export of our products; and criminal prosecution of us, our suppliers, or our employees. Any of these actions could significantly and negatively affect supply of our products. If any of these events occurs, our reputation could be harmed, we could be exposed to product liability claims and we could lose customers and experience reduced sales and increased costs.

Obtaining and maintaining regulatory authorization of our products in one jurisdiction does not mean that we will be successful in obtaining regulatory authorization of our products in other jurisdictions.

Obtaining and maintaining regulatory authorization of products in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory authorization in any other jurisdiction, but a failure or delay in obtaining regulatory authorization in one jurisdiction may have a negative effect on the regulatory authorization process in others. For example, even if the FDA or a comparable foreign regulatory authority grants clearance or approval of our products, comparable regulatory authorities in foreign jurisdictions may also need to authorize the products in those countries, which may be a new review process. Premarket authorization processes vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional clinical studies, because clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions or the data may not be considered applicable to the jurisdiction’s intended patient population. In some cases, the price that we intend to charge for our products may also be subject to approval.

Obtaining foreign regulatory authorization and maintaining compliance with foreign regulatory requirements could result in significant delays, difficulties, and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in other jurisdictions, or we fail to receive necessary or desirable marketing authorizations in other jurisdictions, our target market will be reduced and our ability to realize the full market potential of our products will be harmed.

Clinical trials may be necessary to support future product submissions to the FDA. These clinical trials are expensive and will require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Delays or failures in our clinical trials will prevent us from commercializing any in-development, modified or new diagnostic tests and will adversely affect our business, operating results and prospects.

Initiating and completing clinical trials necessary to support any future PMA applications or other regulatory premarket submissions, and additional safety and efficacy data beyond that typically required for a 510(k) clearance for our possible future product candidates, will be time consuming and expensive and the outcome uncertain. Moreover, the results of early clinical trials are not necessarily predictive of future results, and any product we advance into clinical trials may not have favorable results in later clinical trials.

Conducting successful clinical studies will require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the patient population, the nature of the trial protocol, the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects, the availability of appropriate clinical trial investigators, support staff, and proximity of patients to clinical sites and ability to comply with the eligibility and exclusion criteria for participation in the clinical trial and patient compliance.

Development of sufficient and appropriate clinical protocols to demonstrate safety and efficacy is required and we may not adequately develop such protocols to support FDA clearance and approval. Further, the FDA may require us to submit data on a greater number of patients than we originally anticipated and/or for a longer follow-up period or change the data collection requirements or data analysis applicable to our clinical trials. Delays in patient enrollment or failure of patients to continue to participate in a clinical trial may cause an increase in costs and delays in the approval and attempted commercialization of our diagnostic tests or result in the failure of the clinical trial. In addition, despite considerable time and expense invested in our clinical trials, the FDA may not consider our data adequate to demonstrate safety and efficacy. Such increased costs and delays or failures could adversely affect our business, operating results and prospects.

If the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory clearance or approval for or commercialize our diagnostic tests and services.

We may not have the ability to independently conduct our pre-clinical and clinical trials for our future diagnostic tests and services and we must rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such trials. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated. Additionally, we may not be able to obtain regulatory approval for, or successfully commercialize, our diagnostic tests and services on a timely basis, if at all, and our business, operating results and prospects may be adversely affected. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of their control.

The data that we collect may be vulnerable to breach, loss or misuse, and our handling of such data may be impacted by changes in data privacy and protection laws and regulations, which could increase operational costs or result in regulatory penalties, litigation, or reputational harm.

In connection with our business, we maintain and process, and our third-party vendors, collaborators, contractors and consultants maintain and process on our behalf, a large quantity of sensitive information, including confidential business, personal and patient health information in connection with our clinical studies and our employees, and may be subject to data privacy and protection laws and regulations that apply to the collection, transmission, storage and use of personally identifying information, which among other things, impose certain requirements relating to the privacy, security and transmission of personal information. Despite our efforts to properly handle and protect this information in compliance with all applicable regulatory requirements, our facilities and systems and those of our third-party vendors, collaborators, contractors and consultants may be vulnerable to security breaches, theft, misplaced or lost data, and programming, procedural or human errors that could potentially lead to such information being compromised of handled improperly.

These laws, rules and regulations – both domestic and foreign – evolve frequently, and their scope may continually change, through new legislation, amendments to existing legislation and changes in enforcement, and may be inconsistent from one jurisdiction to another. The interpretation and application of consumer, health-related and data protection laws, especially with respect to genetic samples and data, in the United States, the EU and elsewhere, are often uncertain and contradictory. As a result, implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future.

In the United States, we may be subject to numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators. For example, the State of California legislature passed the California Consumer Privacy Act of 2018 (the “CCPA”), effective January 1, 2020, which grants certain rights to California residents with respect to their personal information.

In addition, we may eventually operate in a number of countries outside of the United States whose laws may in some cases be more stringent than the requirements in the United States. The EU has specific requirements relating to cross-border transfers of personal data to certain jurisdictions, including to the United States. For example, since May 25, 2018, the GDPR has regulated the collection and use of personal data of data subjects in the EU and the European Economic Area. The GDPR applies extra-territorially under certain circumstances and imposes stringent requirements on controllers and processors of personal data, including, for example, requirements to obtain consent or other legal bases from individuals to process their personal data, provide robust disclosures to individuals, accommodate a set of individual data rights, provide data security breach notifications within 72 hours after discovering the breach, limit retention of personal information and apply enhanced protections to health data and other special categories of personal data. The GDPR provides that EU member states may make their own further laws and regulations limiting the processing of personal data, including genetic, biometric or health data, which could limit our ability to use and share personal data, could cause our costs to increase and could harm our financial condition. Failure to comply with the requirements of the GDPR and the applicable national data protection laws of the EU member states may result in significant fine, penalties, third-party liability, remediation costs, and others. To comply with the new data protection rules imposed by the GDPR, we may be required to put in place additional mechanisms ensuring compliance, which may result in other substantial expenditures. This may be onerous and adversely affect our business, financial condition, results of operations and the profitability of our platform of diagnostic tests. Currently, the GDPR is only applicable to us as a processor, but as we continue to expand into the European market, the GDPR will have direct applicability to us as a controller.

As we address the requirements of GDPR, CCPA and other applicable data privacy regulations, the actions taken by us may not prevent all data security breaches or ensure full compliance with all data privacy-related regulations or customer requirements, and any significant breach of the foregoing could have a material adverse effect on our business and reputation, as well as our financial condition, results of operations and cash flows.

Failure to comply with the HIPAA Privacy, Security and Breach Notification Regulations, as such rules become applicable to our business, may increase our operational costs.

Numerous state and federal laws and regulations govern the collection, dissemination, use, privacy, confidentiality, security, availability, integrity, and other processing of protected health information (“PHI”) and personal identifiable information (“PII”). These laws and regulations include HIPAA. HIPAA establishes a set of national privacy and security standards for the protection of PHI by health plans, healthcare clearinghouses and certain healthcare providers, referred to as covered entities, and the business associates with whom such covered entities contract for services. We are a covered entity under HIPAA when we are conducting our clinical trials. We are a covered entity with regard to our observational studies and clinical trials, and also a business associate under HIPAA for certain other business activities, and we execute business associate agreements with our clients.

HIPAA requires covered entities and business associates, such as us, to develop and maintain policies with respect to the protection of, use and disclosure of electronic PHI, including the adoption of administrative, physical and technical safeguards to protect such information, and certain notification requirements in the event of a data breach.

HIPAA imposes mandatory penalties for certain violations. Penalties for violations of HIPAA and its implementing regulations start at $127 per violation and are subject to a cap of $1,919,173 for violations of the same standard in a single calendar year. However, a single breach incident can result in violations of multiple standards. HIPAA also authorizes state attorneys general to file suit on behalf of their residents. Courts may award damages, costs and attorneys’ fees related to violations of HIPAA in such cases. While HIPAA does not create a private right of action allowing individuals to sue us in civil court for violations of HIPAA, its standards have been used as the basis for duty of care in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI.

In addition, HIPAA mandates that the Secretary of HHS conduct periodic compliance audits of HIPAA covered entities and business associates. With regard to business associates, those audits assess the business associate’s compliance with the HIPAA Privacy and Security Standards. Such audits are conducted randomly and after an entity experiences a breach affecting more than 500 individuals’ data. Undergoing an audit can be costly, can result in fines or onerous obligations, and can damage a business associate’s reputation.

In addition to HIPAA, numerous other federal, state, and foreign laws and regulations protect the confidentiality, privacy, availability, integrity and security of PHI and other types of PII. Some of these laws and regulations may be pre-empted by HIPAA with respect to PHI, or may exclude PHI from their scope but impose obligations with regard to PII that is not PHI, and in some cases, can impose additional obligations with regard to PHI. These laws and regulations are often uncertain, contradictory, and subject to changing or differing interpretations, and we expect new laws, rules and regulations regarding privacy, data protection, and information security to be proposed and enacted in the future. This complex, dynamic legal landscape regarding privacy, data protection, and information security creates significant compliance issues for us and our clients and potentially exposes us to additional expense, adverse publicity and liability. While we have implemented data privacy and security measures in an effort to comply with applicable laws and regulations relating to privacy and data protection, some PHI and other PII or confidential information is transmitted to us by third parties, who may not implement adequate security and privacy measures, which can lead to government-imposed fines, orders requiring that we or these third-parties change our or their practices, among others.

If we or these third parties are found to have violated such laws, rules or regulations, it could result in government-imposed fines, orders requiring that we or these third parties change our or their practices, or criminal charges, which could adversely affect our business Complying with these various laws and regulations could cause us to incur substantial costs or require us to change our business practices, systems and compliance procedures in a manner adverse to our business.

Information technology (“IT”) failures and data security breaches, including as a result of cybersecurity attacks, could negatively impact our results of operations and financial condition, subject us to increased operating costs, and expose us to litigation.

We regularly monitor, defend against and respond to attacks to our networks and other information security incidents. Despite our information security efforts, our facilities, systems, and data, as well as those of our third-party service providers, may be vulnerable to privacy and information security incidents such as data breaches, viruses or other malicious code, cybersecurity attacks, coordinated attacks, data loss, phishing attacks, ransomware, denial of service attacks, or other security or IT incidents caused by threat actors, technological vulnerabilities or human error. If we, or any of our vendors that support our IT or have access to our data, including any third-party vendors that collect, process and store personal data on our behalf, fail to comply with laws requiring the protection of personal information, or fail to safeguard and defend personal information or other critical data assets or IT systems, we may be subject to regulatory enforcement and fines as well as private civil actions. We may be required to expend significant resources in the response, containment, mitigation of cybersecurity incidents as well as in defense against claims that our information security was unreasonable or otherwise violated applicable laws or contractual obligations.

Our employees, collaborators, independent contractors and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk that our employees, collaborators, independent contractors and consultants may engage in fraudulent or other illegal activity with respect to our business. Misconduct by these employees could include intentional, reckless and/or negligent conduct or unauthorized activity that violates:

In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Misconduct by these parties could also involve individually identifiable information, including, without limitation, the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. Any incidents or any other conduct that leads to an employee, contractor, or other agent, or our company, receiving an FDA debarment or exclusion by the HHS Office of Inspector General could result in penalties, a loss of business from third parties, and severe reputational harm.

In connection with this offering, we will adopt a Code of Business Conduct and Ethics and compliance policies to govern and deter such behaviors, but it is not always possible to identify and deter misconduct by our employees and other agents, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, treble damages, monetary fines, disgorgement, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and curtailment of our operations.

Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

Our ongoing research and development and clinical trial activities are subject to extensive regulation and review by numerous governmental authorities both in the United States and abroad. We are currently conducting pre-and post-market clinical studies of some of our tests. In the future we may conduct clinical trials to support clearance and approval of new diagnostic tests and services. Clinical studies may need to be conducted in compliance with FDA regulations or the FDA may take enforcement action. The data collected from these clinical studies may ultimately be used to support marketing authorization for these diagnostic tests and services. Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product candidate claims or that the FDA or foreign authorities and notified bodies will agree with our conclusions regarding them. We rely on data collected in foreign countries and we cannot be certain that the FDA accept all of the data collected outside the U.S. as support for our product candidate claims. Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies. The clinical trial process may fail to demonstrate that our tests are safe and effective for the proposed indicated uses, which could cause us to abandon development of our tests and may delay development of others. Any delay or termination of our clinical trials will delay the filing of our product submissions and, ultimately, may impact our ability to commercialize our tests and generate revenues.

Many of the factors that may cause or lead to a delay in the commencement or completion of clinical trials may also ultimately lead to delay or denial of regulatory clearance or approval. The commencement of clinical trials may be delayed due to insufficient patient enrollment, which is a function of many factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical sites and the eligibility criteria for the clinical trial.

We may find it necessary to engage contract research organizations to perform data collection and analysis and other aspects of our clinical trials, which might increase the cost and complexity of our trials. We may also depend on clinical investigators, medical institutions and contract research organizations to perform the trials, and would control only certain aspects of their activities. Nevertheless, we would be responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on these third parties would not relieve us of our regulatory responsibilities. We and our third-party contractors are required to comply with good clinical practices (“GCPs”) which are regulations and guidelines enforced by the FDA, and comparable regulations enforced by foreign regulatory authorities for products in clinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any third-party contractor fails to comply with applicable GCPs, the clinical data generated in clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before clearing or approving our marketing applications. A failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory clearance or approval process. In addition, if these parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, or if the quality, completeness or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or for other reasons, our clinical trials may have to be extended, delayed or terminated.

Many of these factors could be beyond our control. We may not be able to undertake additional trials, repeat trials or enter into new arrangements with third parties without undue delays or considerable expenditures. If there are delays in testing or clearances or approvals as a result of the failure to perform by third parties, our research and development costs would increase, and we may not be able to obtain regulatory clearance or approval for our tests. In addition, we may not be able to establish or maintain relationships with these parties on favorable terms, if at all. Each of these outcomes would harm our ability to market our tests, or to achieve sustained profitability.

We and our third-party suppliers must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do, or interrupt our, business.

Our research and development activities and our third-party manufacturers’ and suppliers’ activities involve the generation, use, storage and disposal of hazardous materials. We work with materials, including chemicals, biological agents and compounds and samples that could be hazardous to human health and safety or the environment. Our operations also produce hazardous and biological waste products. Accordingly, we and our third-party manufacturers and suppliers are subject to federal, state, local and foreign environmental, health and safety laws and regulations, and permitting and licensing requirements, including those governing the generation, use, manufacture, storage, handling, transportation, release and disposal of, and exposure to, these materials, and worker health and safety.

We cannot eliminate the risk of contamination or injury resulting from such hazardous materials. We also cannot guarantee that the procedures utilized by our third-party manufacturers for handling and disposing of hazardous materials and wastes comply with all applicable environmental, health and safety laws and regulations. As a result, we may be held liable for any resulting damages, costs or liabilities, including clean-up costs and liabilities, which could be significant, or our commercialization, research and development efforts and business operations may be restricted or interrupted.

Environmental, health and safety laws and regulations are complex, change frequently and have tended to become more stringent. Compliance with such laws and regulations is expensive, and current or future environmental, health and safety laws and regulations may restrict our operations. If we do not comply with applicable environmental health and safety laws and regulations, and permitting and licensing requirements, we may be subject to fines, penalties, a suspension of our business or other sanctions.

Risks Related to Our Intellectual Property

Our success may be impaired if we are unable to obtain, maintain and protect our intellectual property rights.

Our commercial success will depend in part on our ability to obtain and maintain patent and other intellectual property protection in the United States and other countries with respect to our diagnostic tests, products and services and technology. We rely on patent protection, as well as a combination of copyright, trade secret and trademark laws, to protect our proprietary technology and prevent others from duplicating our suite of diagnostic tests and products. However, these means may afford only limited protection and may not:

Seven out of the nine patent families issued in MDNA’s portfolio will expire within the next six years. Composition of matter and diagnostic methods patents relating to the Mitomic® Prostate Test and breast cancer assays that are still in development and have not yet been approved under the regulations of the FDA or any other regulator are among the patents that expire within six years, with several of these patents expiring as soon as 2026. Specifically, 34 issued and one pending patent from eight families relating to MPT, prostate, and breast cancer assays expire within the next 6 years, with 17 of those issued patents from three of those families relating to MPT and prostate cancer expiring in 2026. Expiration of patents negatively impacts the ability to license the patent rights directly as well as enforce our rights against competitors. Competitors may reverse-engineer our products and compete directly with us in any market where a patent is no longer in force. This may require MDNA to reduce the sales price of existing products to remain competitive, invest in further research and development to improve product performance and obtain new patent protection, and/or expend additional funds on marketing to promote brand loyalty. Any of our patents, including those we may license, may be challenged, invalidated, rendered unenforceable or circumvented. Consequently, we do not know whether any of our diagnostic tests, products and services will be protectable or remain protected by valid and enforceable patents. We may not prevail if our patents are challenged by competitors or other third parties. Furthermore, competitors may be able to design around our patents by developing similar or alternative technologies or products in a non-infringing manner, or obtain patent protection for more effective technologies, designs or methods, including for treating cancer and endometriosis. If these developments were to occur, our diagnostic tests and products may become less competitive, and sales may decline.

We have filed 14 patent applications seeking protection of diagnostic tests and other inventions originating from our research and development. Our patent applications may not result in issued patents, and any patents that are issued may not provide meaningful protection against competitors or competitive technologies. Further, the examination process may require us to narrow the claims for our pending patent applications, which may limit the scope of patent protection that may be obtained if these applications issue. The scope of a patent may also be reinterpreted and significantly reduced after issuance. Even if patent applications we license or own currently or in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide us with the protection or competitive advantages we are seeking.

Moreover, some of our patents and patent applications may in the future be co-owned with third parties. If we are unable to obtain or maintain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners of our patents in order to enforce such patents against third parties, and such cooperation may not be provided to us. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

The patent position of biotechnology companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. No consistent policy regarding the breadth of claims allowed in biotechnology and pharmaceutical patents has emerged to date in the United States or in many foreign jurisdictions. For that reason, outcomes remain unpredictable, which could weaken our and our licensors’ ability to obtain new patents or to enforce our existing owned or in-licensed patents and patents that we might obtain or in-license in the future. In addition, the determination of patent rights with respect to pharmaceutical compounds and technologies commonly involves complex legal and factual questions, which has in recent years been the subject of much litigation. Various courts, including the United States Supreme Court have rendered decisions that affect the scope of patentability of certain inventions or discoveries relating to biotechnology. These decisions state, among other things, that a patent claim that recites an abstract idea, natural phenomenon or law of nature (for example, the relationship between particular genetic variants and cancer) are not themselves patentable. Precisely what constitutes a law of nature or abstract idea is uncertain, and it is possible that certain aspects of our technology could be considered unpatentable under applicable law. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. Additionally, our pending and future patent applications may not result in patents being issued which protect our technology or products or which effectively prevent others from commercializing competitive technologies and products. The scope of patent protection outside of the United States is also uncertain. Changes in either the patent laws or their interpretation in the United States and other countries may diminish our ability to protect our inventions, obtain, maintain, and enforce our intellectual property rights and, more generally, could affect the value of our intellectual property rights or narrow the scope of our owned and licensed patents.

If we are unable to obtain and maintain patent protection for our technology, or if the scope of the patent protection obtained is not sufficient, our competitors could develop and commercialize diagnostic tests, products and services similar or superior to ours, and our competitive position may be adversely affected. It is also possible that we will fail to identify patentable aspects of inventions made in the course of our development and commercialization activities before it is too late to obtain patent protection on them. Therefore, we may miss potential opportunities to strengthen our patent position. In addition, the patent prosecution process is expensive, time-consuming and complex, and we may not be able to file, prosecute, maintain, enforce or license all necessary or desirable patent applications at a reasonable cost or in a timely manner.

Additionally, while software and other of our proprietary works may be protected under copyright law, we have chosen not to register any copyrights in these works, and instead, primarily rely on protecting our software as a trade secret. In order to bring a copyright infringement lawsuit in the United States, the copyright must be registered. Accordingly, the remedies and damages available to us for unauthorized use of our copyrights may be limited.

 If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.

In addition to seeking patent protection for the patents underlying our diagnostic tests, products and services, we also rely upon unpatented trade secrets, know-how and continuing technological innovation to develop and maintain a competitive position. Trade secrets and know-how can be difficult to protect. We seek to protect such proprietary information, in part, through confidentiality agreements with our employees, collaborators, contractors, advisors, consultants and other third parties and invention assignment agreements with our employees. We also have agreements with some of our consultants that require them to assign to us any inventions created as a result of their working with us. The confidentiality agreements are designed to protect our proprietary information and, in the case of agreements or clauses containing invention assignment, to grant us ownership of technologies that are developed through a relationship with employees or third parties.

Additionally, despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to, or independently developed by, a competitor or other third party, our competitive position would be materially and adversely harmed. Furthermore, we expect these trade secrets, know-how and proprietary information to over time be disseminated within the industry through independent development, the publication of journal articles describing the methodology and the movement of personnel from academic to industry scientific positions. Consequently, we may be unable to prevent our proprietary technology from being exploited in the United States and abroad, which could affect our ability to expand in domestic and international markets or require costly efforts to protect our technology.

Additionally, we may be subject to claims from third parties challenging our ownership interest in intellectual property rights we regard as our own, based on claims that our employees or consultants have breached an obligation to assign inventions to another employer, to a former employer, or to another person or entity. Litigation may be necessary to defend against any other claims, and it may be necessary, or we may desire to enter into a license to settle any such claim; however, there can be no assurance that we would be able to obtain a license on commercially reasonable terms, if at all. If our defense to those claims fails, in addition to paying monetary damages, a court could prohibit us from using technologies or features that are essential to our diagnostic tests or products, if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers.

Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our in-development and future diagnostic tests, products and services.

Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. In 2011, the Leahy-Smith America Invents Act (the “Leahy-Smith Act”) was signed into law. The Leahy-Smith Act includes a number of significant changes to United States patent law, including the way patent applications are prosecuted and litigated. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition and results of operations.

In addition, patent reform legislation and judicial holdings may pass in the future that could lead to additional uncertainties and increased costs surrounding the prosecution, enforcement and defense of our patents and applications. Similarly, foreign courts have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted. We cannot predict future changes in the interpretation of patent laws or changes to patent laws that might be enacted into law by United States and foreign legislative bodies. Those changes may materially affect our patents or patent applications and our ability to obtain additional patent protection in the future.

If our trademarks and tradenames are not adequately protected, then we may not be able to build name recognition in our markets and our business may be adversely affected.

Our trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be violating or infringing on other marks. We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these trademarks or trade names, which we need to build name recognition among potential partners and customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement, or dilution claims brought by owners of other trademarks. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected.

We have not yet registered certain of our trademarks in all of our potential markets, although we have registered several connected to our diagnostic tests, products and services in the United States. If we apply to register these and trademarks in the United States and other countries, our applications may not be allowed for registration in a timely fashion or at all, and our registered trademarks may not be maintained or enforced. During trademark registration proceedings, we may receive rejections. Although we would be given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the United States Patent and Trademark Office (USPTO) and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademark applications and registrations, and our trademarks may not survive such proceedings. If we do not secure registrations for our trademarks, we may encounter more difficulty in enforcing them against third parties than we otherwise would.

Our efforts to enforce or protect our rights related to trademarks, trade secrets, domain names or other intellectual property rights may be ineffective, could result in substantial costs and diversion of resources and could adversely affect our business, financial condition and results of operations.

We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or other intellectual property rights, which could be expensive, time consuming and unsuccessful.

Competitors or other third parties may infringe, misappropriate or otherwise violate our patents, the patents of our licensors or other intellectual property rights, or we may be required to defend against claims of infringement, misappropriation or other violations. In addition, our patents also may become involved in inventorship, priority or validity disputes. To counter or defend against such claims can be expensive and time-consuming. Even if resolved in our favor, litigation or other proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our management and other personnel from their normal responsibilities. If securities analysts or investors perceive the litigation developments or proceedings results to be negative, it could have a substantial adverse effect on the price of our Common Stock and Warrants.

Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Further, any claims we assert against perceived infringers can lead to those parties asserting counterclaims against us alleging infringement from our side. These proceedings can lead to our intellectual property right to be deemed invalid or unenforceable, which have unpredictable outcomes, but may include us losing at least part, or all, of the patent protection on our diagnostic tests, products and services. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation.

Third parties also may raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions, including opposition proceedings. Such proceedings could result in the revocation or cancellation of or amendment to our patents in such a way that they no longer cover our diagnostic tests, products and services or prevent third parties from competing with our diagnostic tests, products and services.

Any of the foregoing could have a material adverse effect on our business, financial condition or results of operations.

Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States at several stages over the lifetime of the patents and/or applications. We have systems in place to remind us to pay these fees, and we employ an outside firm and rely on our outside counsel to pay these fees due to non-United States patent agencies. We are also dependent on our licensors to take the necessary action to comply with these requirements with respect to our licensed intellectual property rights. The USPTO and various non-US governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. We employ reputable law firms and other professionals to help us comply, and in some cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which non-compliance 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. In such an event, our competitors may be able to enter the market without infringing our patents and this circumstance would have a material adverse effect on our business.

We may not have been the first company to make the inventions covered by our pending patents because publications of discoveries in the scientific literature often lag behind the actual discoveries.

We may not be aware of all third-party intellectual property rights potentially relating to our current or future diagnostic tests, products or services. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until approximately 18 months after filing or, in some cases, not until such patent applications issue as patents. We, or our current or future license partners or collaborators, might not have been the first to make the inventions covered by each of our pending patent applications and we might not have been the first to file patent applications for these inventions. To determine the priority of these inventions, we may have to participate in interference proceedings, derivation proceedings or other post-grant proceedings declared by the USPTO. The outcome of such proceedings is uncertain, and other patent applications may have priority over our patent applications. Such proceedings could also result in substantial costs to us and divert our management’s attention and resources.

Patent terms may be inadequate to protect our competitive position on our in-development and future diagnostic tests, products and services for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest United States non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Seven out of the nine patent families issued in MDNA’s portfolio will expire within the next six years.

Even if patents covering our diagnostic tests, products and services are obtained, once the patent life has expired, we may be open to competition from competitive diagnostic tests, products and services. Given the amount of time required for the development, testing and regulatory review of potential new diagnostic tests, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing diagnostic tests, products or services similar or identical to ours.

We may not be able to protect our intellectual property rights throughout the world.

Third parties may attempt to commercialize competitive diagnostic tests, products or services in foreign countries where we do not have any patents or patent applications and/or where legal recourse may be limited. This may have a significant commercial impact on our foreign business operations.

Filing, prosecuting and defending patents on our diagnostic tests, products and services in all countries throughout the world would be prohibitively expensive, and the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing diagnostic tests or products made using our inventions in and into the United States or other jurisdictions. Competitors may use our diagnostic tests, products, services and technologies in jurisdictions where we have not obtained patent protection to develop their own diagnostic tests and, further, may export otherwise infringing diagnostic tests or products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These diagnostic tests and products may compete with our diagnostic tests, products or services and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many countries, including India, China, and certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we or any of our current or future licensors are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition and results of operations may be adversely affected.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.

Risks Related to this Offering and Ownership of Our Common Stock and Warrants

There has been no prior public market for our Common Stock and Warrants and an active trading market may not develop.

Prior to this offering, there has been no public market for our Common Stock and Warrants. An active trading market may not develop following completion of this offering or, if developed, may not be sustained. The lack of an active trading market may impair the value of your shares of Common Stock and Warrants and your ability to sell your shares of Common Stock and Warrants at the time you wish to sell them. An inactive trading market may also impair our ability to both raise capital by selling shares of Common Stock and Warrants and acquire other complementary diagnostic tests, technologies or businesses by using our shares of Common Stock and Warrants as consideration.

Upon closing of this offering, we expect that our Common Stock and Warrants will be listed on the Nasdaq Capital Market. If we fail to satisfy the continued listing standards of the Nasdaq Capital Market, however, we could be de-listed, which would negatively impact the price of our Common Stock and Warrants. In addition, our board may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing. A de-listing of our Common Stock and Warrants from the Nasdaq Capital Market may materially impair our shareholders’ ability to buy and sell our Common Stock and Warrants and could have an adverse effect on the market price of, and the efficiency of the trading market for, our Common Stock and Warrants. In addition, the delisting of our Common Stock and Warrants could significantly impair our ability to raise capital in the future.

If we fail to meet the minimum requirements for listing on the Nasdaq Capital Market, we will not proceed with this offering.

Currently, our officers and directors own a large number of our outstanding stock, and, as a result, they may have certain influence in the corporate decisions of the Company.

Currently, our directors, and officers beneficially own 93% of the Company’s current outstanding Common Stock entitled to vote, and such stockholders’ interests may conflict with other stockholders, who may be unable to influence management and exercise control over our business. Following the consummation of this offering, our directors and officers will own approximately 38% of our shares of Common Stock. As a consequence, our directors and officers will have the power to affect our management and affairs and overall matters requiring stockholder approval, including the election of directors and significant corporate transactions, such as a merger or other sale of the Company or our assets, for the foreseeable future. This concentrated control limits or restricts the ability of our other stockholders to influence corporate matters and, as a result, we may take actions that our stockholders do not view as beneficial, and the market price of our Common Stock could be adversely affected.

We expect that the price of our Common Stock and Warrants will fluctuate substantially, and you may not be able to sell the shares you purchase in this offering at or above the offering price.

The initial public offering price for the shares of our Common Stock and Warrants sold in this offering is determined by negotiation between the representatives of the underwriters and us. This price may not reflect the market price of our Common Stock and Warrants following this offering. In addition, the market price of our Common Stock and Warrants is likely to be highly volatile and may fluctuate substantially due to many factors, including:

In recent years, the stock markets generally have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of listed companies. Broad market and industry factors may significantly affect the market price of our Common Stock and Warrants, regardless of our actual operating performance. These fluctuations may be even more pronounced in the trading market for our Common Stock and Warrants shortly following this offering. If the market price of shares of our Common Stock and Warrants after this offering does not ever exceed the initial public offering price, you may not realize any return on your investment in us and may lose some or all of your investment.

In addition, in the past, class action litigation has often been instituted against companies whose securities have experienced periods of volatility in market price. Securities litigation brought against us following volatility in our stock price, regardless of the merit or ultimate results of such litigation, could result in substantial costs, which would hurt our financial condition and operating results and divert management’s attention and resources from our business.

Securities analysts may not publish favorable research or reports about our business or may publish no information at all, which could cause our stock price or trading volume to decline.

If a trading market for our Common Stock and Warrants develops, the trading market will be influenced to some extent by the research and reports that industry or financial analysts publish about us and our business. We do not control these analysts. As a newly public company, we may be slow to attract research coverage and the analysts who publish information about our Common Stock and Warrants will have had relatively little experience with us, which could affect their ability to accurately forecast our results and could make it more likely that we fail to meet their estimates. In the event we obtain securities or industry analyst coverage, if any of the analysts who cover us provide inaccurate or unfavorable research or issue an adverse opinion regarding our stock price, our stock price could decline. If one or more of these analysts cease coverage of us or fail to publish reports covering us regularly, we could lose visibility in the market, which in turn could cause our stock price or trading volume to decline.

We are an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our Common Stock and Warrants less attractive to investors.

We are an “emerging growth company,” as defined in the JOBS Act. We may take advantage of certain exemptions and relief from various public reporting requirements, including the requirement that our internal control over financial reporting be audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 (the Sarbanes-Oxley Act). We will be exempt from any rules that could be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotations or a supplement to the auditor’s report on financial statements; we will be subject to reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and we will not be required to hold nonbinding advisory votes on executive compensation or stockholder approval of any golden parachute payments not previously approved.

Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.

We have elected to take advantage of the extended transition period to comply with new or revised accounting standards and to adopt certain of the reduced disclosure requirements available to emerging growth companies. As a result of the 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. Additionally, because we have taken advantage of certain reduced reporting requirements, the information contained herein may be different from the information you receive from other public companies in which you hold stock.

We will remain an “emerging growth company” until the earliest to occur of (i) the last day of the fiscal year in which we have more than $1.235 billion in annual revenue; (ii) the date we qualify as a “large accelerated filer,” with at least $700 million of equity securities held by non-affiliates; (iii) the date on which we have issued, in any three-year period, more than $1.0 billion in non-convertible debt securities; and (iv) the last day of the fiscal year ending after the fifth anniversary of the completion of our initial public offering.

We are also a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our common shares held by non-affiliates exceeds $250 million as of the end of that year’s second fiscal quarter, or (2) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our common shares held by nonaffiliates exceeds $700 million as of the end of that year’s second fiscal quarter. To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible.

Investors may find our Common Stock and Warrants less attractive to the extent we rely on the exemptions and relief granted by the JOBS Act. If some investors find our Common Stock and Warrants less attractive as a result, there may be a less active trading market for our Common Stock and Warrants and the price of our Common Stock and Warrants may decline or become more volatile.

If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below the expectations of securities analysts and investors, resulting in a decline in the market price of our Common Stock and Warrants.

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, revenue and expenses that are not readily apparent from other sources. It is possible that interpretation, industry practice and guidance may evolve over time. If our assumptions change or if actual circumstances differ from our assumptions, our operating results may be adversely affected and could fall below the expectations of securities analysts and investors, resulting in a decline in the market price of our Common Stock and Warrants.

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

Investors purchasing Units in this offering will pay a price per Unit that substantially exceeds the pro forma as adjusted net tangible book value per share. As a result, investors purchasing Units in this offering will incur immediate dilution of $4.62 per Unit, based on an assumed initial public offering price of $5.00 per Unit, the midpoint of the estimated offering price range set forth on the cover page of this prospectus, and our pro forma as adjusted net tangible book value per share of Common Stock as of December 31, 2022. For more information on the dilution you may suffer as a result of investing in this offering, see the section of this prospectus entitled “Dilution.”

This dilution is due to the substantially lower price paid by our investors who purchased shares prior to this offering as compared to the price offered per Unit to the public in this offering. It is also due to the conversion of our Series A Preferred Stock and convertible debt into shares of our Common Stock upon the completion of this offering and the exercise of stock options granted to our employees as the conversion and exercise prices of such securities and options are substantially below the price offered per Unit to the public in this offering.

A significant portion of our total outstanding shares are restricted from immediate resale but may be sold into the market in the near future. This could cause the market price of our Common Stock and Warrants to drop significantly, even if our business is doing well.

Sales of a substantial number of shares of our Common Stock and Warrants in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares intend to sell their shares, could result in a decrease in the market price of our Common Stock and Warrants. Immediately after this offering and after giving effect to the Preferred Conversions and Secured Convertible Notes Conversions, we will have 9,405,456 outstanding shares of Common Stock based on the number of shares outstanding as of December 31, 2022. This includes the shares that we are selling in this offering, which may be resold in the public market immediately without restriction, unless purchased by our affiliates. Of the remaining shares, shares are currently restricted as a result of securities laws or 180-day lock-up agreements but will be able to be sold after the offering as described in the section of this prospectus entitled “Shares Eligible For Future Sale.” Moreover, after this offering, holders of an aggregate of up to 1,682,264 shares of our Common Stock issuable upon the conversion of the shares of our Series A Preferred Stock that will be outstanding immediately prior to the consummation of this offering, will have rights, subject to some conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. We also intend to register all shares of Common Stock that we may issue under our equity compensation plans. Once we register these shares, they can be freely sold in the public market, subject to volume limitations applicable to affiliates and the lock-up agreements described in the section of this prospectus entitled “Underwriters.”

We may allocate the net proceeds from this offering in ways that you and other stockholders may not approve.

Our management will have broad discretion in the application of the net proceeds from this offering, including for any of the purposes described in the section titled “Use of Proceeds.” Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. Our management might not apply our net proceeds in ways that ultimately increase the value of your investment, and the failure by our management to apply these funds effectively could harm our business. Pending their use, we may invest the net proceeds from this offering in short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the United States government. These investments may not yield a favorable return to our stockholders. If we do not invest or apply the net proceeds from this offering in ways that enhance stockholder value, we may fail to achieve expected results, which could cause our stock price to decline.

We expect to incur significant additional costs as a result of being a public company, which may adversely affect our business, financial condition and results of operations.

Upon completion of this offering, we expect to incur costs associated with corporate governance requirements that will become applicable to us as a public company, including rules and regulations of the SEC, under the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, and the Securities Exchange Act of 1934, as amended (the Exchange Act), as well as the rules of Nasdaq. These rules and regulations are expected to significantly increase our accounting, legal and financial compliance costs and make some activities more time-consuming. We also expect these rules and regulations to make it more expensive for us to maintain directors’ and officers’ liability insurance. As a result, it may be more difficult for us to attract and retain qualified persons to serve on our Board of Directors (the “Board of Directors”) or as executive officers. Accordingly, increases in costs incurred as a result of becoming a publicly traded company may adversely affect our business, financial condition and results of operations.

If we experience material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our Common Stock and Warrants.

As a result of becoming a public company, we will be required, under Section 404 of the Sarbanes-Oxley Act to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting beginning with our Annual Report on Form 10-K for the year ended September 30, 2022. This assessment will need to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting. A material weakness is a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual and interim financial statements will not be detected or prevented on a timely basis.

We are further enhancing internal controls, processes and related documentation necessary to perform the evaluation needed to comply with Section 404. We may not be able to complete our evaluation, testing and any required remediation in a timely fashion. During the evaluation and testing process, if we identify one or more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal controls are effective. The effectiveness of our controls and procedures may be limited by a variety of factors, including:

When we cease to be an “emerging growth company” under the federal securities laws, our auditors will be required to express an opinion on the effectiveness of our internal controls. If we are unable to confirm that our internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express an opinion on the effectiveness of our internal controls, we could lose investor confidence in the accuracy and completeness of our financial reports, which could cause the price of our Common Stock and Warrants to decline.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Upon the closing of this offering, we will become subject to the periodic reporting requirements of the Exchange Act. We designed our disclosure controls and procedures to provide reasonable assurance that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

Provisions in our corporate charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Provisions in our certificate of incorporation and our bylaws may discourage, delay or prevent a merger, acquisition or other change in control of us that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of our Common Stock and Warrants, thereby depressing the market price of our Common Stock and Warrants. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our Board of Directors. Because our Board of Directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team.

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.

Our certificate of incorporation provides that we will indemnify our directors and officers to the fullest extent permitted by Section 145 of the Delaware General Corporate Law.

In addition, as permitted by the Delaware General Corporate Law, our certificate of incorporation and our indemnification agreements that we have entered into with our directors and officers provide that:

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY AND MARKET DATA 

Special Note Regarding Forward-Looking Statements

This prospectus contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections titled “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” but are also contained elsewhere in this prospectus. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future, although not all forward-looking statements contain these words. These statements relate to future events or our future financial performance or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements.

Key factors that could cause actual results to be different than expected or anticipated include, but are not limited to:

You should read this prospectus, including the section titled “Risk Factors,” and the documents that we reference elsewhere 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 results may differ materially from what we expect as expressed or implied by our forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.

These forward-looking statements represent our estimates and assumptions only as of the date of this prospectus regardless of the time of delivery of this prospectus or any sale of our Common Stock and Warrants. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this prospectus. All subsequent 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 herein.

Industry and Market Data

Unless otherwise indicated, information contained in this prospectus concerning our industry and the markets in which we operate, including our general expectations and market opportunity and market size, is based on information from various sources, including independent industry publications, such as Market Intel, the American Urological Association, the American Society for Clinical Oncology, and the American College of Obstetrics and Gynecology. In presenting this information, we have also made assumptions based on such data and other similar sources, and on our knowledge of, and our experience to date in, the markets for our products. This information involves a number of assumptions and limitations. We believe that the information from these industry publications that is included in this prospectus is reliable. The industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors.” These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.

USE OF PROCEEDS

We estimate that we will receive net proceeds from this offering of approximately $9.2 million (or $10.6 million if the representative of the underwriters exercise its over-allotment option to purchase additional shares of Common Stock and/or Warrants in full), based upon an assumed initial public offering price of $5.00 per Unit, which is the mid-point of the price range set forth on the cover page of this prospectus, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

Each $1.00 increase or decrease in the assumed initial public offering price of $ 5.00 per Unit, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, would increase or decrease, as applicable, the net proceeds to us from this offering by approximately $1.9 million, assuming the number of Units offered by us, as set forth on the cover page of this prospectus, remains the same. We may also increase or decrease the number of Units we are offering. Each increase or decrease of 100,000 in the number of Units we are offering at the assumed initial public offering price of $5.00 per Unit, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, would increase or decrease, as applicable, the net proceeds to us from this offering by approximately $460,000, assuming the assumed initial public offering price remains the same.

We intend to use the net proceeds from this offering as follows:

This expected use of net proceeds from this offering represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. The amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of our development, the status of and results from clinical trials, our sales, marketing and manufacturing efforts, any collaborations that we may enter into with third parties for our products and any unforeseen cash needs. As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering.

We believe opportunities may exist from time to time to expand our current business through the acquisition or in-license of complementary products and product candidates. While we have no current agreements or commitments for any specific acquisitions or in-licenses at this time, we may use a portion of the net proceeds for these purposes.

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

DIVIDEND POLICY

We have never declared or paid any cash dividends on our capital stock. We do not anticipate paying cash dividends on our Common Stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to support our operations and finance the growth and development of our business. Any future determination related to our dividend policy will be made at the discretion of our Board of Directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements, contractual restrictions, business prospects, the requirements of current or then-existing debt instruments and other factors our Board of Directors may deem relevant.

CAPITALIZATION

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

The pro forma and pro forma as adjusted information below is illustrative only and our capitalization following the completion of this offering is subject to adjustment based on the initial public offering price of our Units and other terms of this offering determined at pricing. You should read the following table in conjunction with “Use of Proceeds,” “Summary Financial Data,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Description of Capital Stock” and other financial information contained in this prospectus, including the financial statements and related notes appearing elsewhere in this prospectus.

The number of shares of our Common Stock to be outstanding after this offering is based on shares of Common Stock outstanding as of December 31, 2022, and excludes:

DILUTION

If you invest in our Units in this offering, your ownership interest will be immediately diluted to the extent of the difference between the initial public offering price per share of our Common Stock (giving no value to the Warrants) and the pro forma as adjusted net tangible book value per share of our Common Stock immediately after this offering. Net tangible book value per share of Common Stock is determined by dividing our total tangible assets less total liabilities by the number of outstanding shares of our Common Stock.

Our historical net tangible book deficit as of December 31, 2022 was $(26,211,730), or $(18.56) per share of Common Stock.

Our pro forma net tangible book value (deficit) as of December 31, 2022 was $(5,582,071), or $(3.95) per share of our Common Stock.

Pro forma net tangible book value (deficit) per share represents the amount of our total tangible assets less our total liabilities, after giving effect to the conversion of all outstanding shares of our Series A Preferred Stock into an aggregate 1,682,264 shares of Common Stock and the conversion of all outstanding convertible debt into an aggregate of 4,211,264 shares of Common Stock upon the closing of this offering. Pro forma net tangible book value (deficit) per share represents pro forma net tangible book value (deficit) divided by the total number of shares outstanding as of December 31, 2022, after giving effect to the pro forma adjustments described above.

Pro forma as adjusted net tangible book value (deficit) is our pro forma net tangible book value, after giving further effect to (i) the sale of 2,100,000 shares of our Common Stock in this offering (giving no value to the Warrants) at an assumed initial public offering price of $5.00 per Unit, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, and (ii) the application of the net proceeds from this offering as described in the section of this prospectus entitled “Use of Proceeds.” This amount represents an immediate increase in pro forma net tangible book value (deficit) of $18.94 per share to our existing shareholders, and an immediate dilution of $4.62 per share to new investors participating in this offering.

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

A $1.00 increase or decrease in the assumed initial public offering price of $5.00 per Unit, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, the pro forma as adjusted net tangible book value (deficit) per share of Common Stock after this offering by approximately $0.20 per share of Common Stock and decrease or increase, as appropriate, the dilution in pro forma net tangible book value (deficit) per share of Common Stock to investors participating in this offering by approximately $0.80 per share of Common Stock, assuming that the number of Units 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, a 100,000 Unit increase or decrease in the number of Units offered by us, as set forth on the cover page of this prospectus, would increase or decrease, as appropriate, the pro forma as adjusted net tangible book value (deficit) per share of Common Stock after this offering by approximately $0.04 and decrease or increase, as appropriate, the dilution in pro forma net tangible book value (deficit) per share of Common Stock to investors participating in this offering by approximately ($0.04), assuming the assumed initial public offering price of $5.00 per Unit, which is the midpoint of the price range set forth on the cover page of this prospectus, remains the same, after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

The pro forma information discussed above is illustrative only and will change based on the actual initial public offering price, number of shares and other terms of this offering determined at pricing.

If the representative of the underwriters exercises its over-allotment option to purchase 315,000 additional shares of our Common Stock and/or Warrants in this offering in full, the pro forma as adjusted net tangible book value will increase to $0.14 per share of Common Stock, representing an immediate increase in pro forma net tangible book value to existing shareholders of $0.14 per share and an immediate dilution of $0.14 per share to new investors participating in this offering.

The following table sets forth, as of December 31, 2022, on the pro forma as adjusted basis described above, the differences between our existing shareholders and the purchasers of Units in this offering with respect to the number of Units purchased from us, the total consideration paid to us and the weighted average price paid per share paid to us, based on an assumed initial public offering price of $5.00 per Unit, which is the midpoint of the price range set forth on the cover page of this prospectus, before deducting underwriting discounts and commissions and estimated offering expenses payable by us:

If the representative of the underwriters exercises its over-allotment option to purchase additional shares of our Common Stock and/or Warrants in this offering in full, the number of shares held by existing shareholders will be reduced to 76% of the total number of shares of Common Stock that will be outstanding upon completion of this offering, and the number of shares of Common Stock held by new investors participating in this offering will be further increased to 24% of the total number of shares of Common Stock that will be outstanding upon completion of the offering.

A $1.00 increase or decrease in the assumed initial public offering price of $5.00 per Unit, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease, as appropriate, the total consideration paid by new investors by $1.9 million, assuming the number of Units we are offering, as set forth on the cover page of this prospectus, remains the same, after deducting underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of Units we are offering. Similarly, each increase or decrease of 100,000 Units in the number of shares offered by us would increase or decrease, as appropriate, the total consideration paid by new investors by $460,000, assuming that the assumed initial price to the public remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

We may choose to raise additional capital through the sale of equity or equity-linked securities 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 any options are issued under our equity incentive plan or we issue additional shares of Common Stock or equity-linked securities in the future, there will be further dilution to investors purchasing in this offering.

The number of shares of our Common Stock to be outstanding after this offering is based on shares of Common Stock outstanding as of December 31, 2022, and excludes:

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

You should read the following discussion of our financial condition and results of operations in conjunction with “Summary Financial Data” and our financial statements and related notes included elsewhere in this prospectus. This discussion and analysis and other parts of this prospectus contain forward-looking statements based upon current beliefs, plans and expectations that involve risks, uncertainties and assumptions. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under “Risk Factors” and 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. Please also see the section entitled “Cautionary Note Regarding Forward-Looking Statements and Industry and Market Data” in this prospectus. All share and per share numbers have been retroactively adjusted to reflect the 1-for-12.14 reverse stock split effected on October 12, 2022.

Overview

We are an innovative life sciences company focused on the development of liquid biopsy tests based on the mitochondrial genome. We have discovered novel biomarkers and designed laboratory assays, which we refer to as our Mitomic Technology, that are intended to use mitochondrial DNA (mtDNA) to detect cancer earlier, more accurately, and less invasively than traditional methods. Though further technical development and clinical validation is required to determine efficacy in multiple diseases and disease states, our management believes that the unique structural and functional characteristics of mtDNA, and more specifically mutated mtDNA, make mtDNA a biological system for biomarker identification, early disease detection, monitoring, risk assessment, and therapeutic targeting.

We have a state-of-the-art clinical laboratory in Newcastle upon Tyne in the UK for research and development (“R&D”) on mitochondrial DNA and development of Mitomic liquid biopsy tests. This laboratory is an ISO 15189:2012 accredited medical testing laboratory – the highest international standard for medical testing, and is used by medical testing regulators worldwide and has capability for services for employers, schools, sports teams, and organizations in the UK and internationally. This bespoke laboratory facility is optimized for contamination prevention including dedicated workspaces for key functions; advanced molecular biology capabilities including digital PCR, real-time PCR, automated electrophoresis with scale-up capacity and redundancy; and automated and semi-automated (robotic) processes for DNA/RNA isolation and liquid handling to achieve efficient and standardized workflows.

Recent Developments

Increase of Authorized Shares

On October 4, 2022, the Company filed an amended and restated certificate of incorporation with the Secretary of State of the State of Delaware, reflecting the increase of its authorized shares to two hundred twenty million 220,000,000, divided into the following classes: 200,000,000 shares of common stock, $.001 par value per share; and 20,000,000 shares of preferred stock, $.001 par value per share.

On January 25, 2023, the Company filed an amended and restated certificate of incorporation with the Secretary of State of the State of Delaware, reflecting the increase of its authorized number of preferred stock to 50,000,000 shares of preferred stock, $.001 par value per share. 

Reverse Stock Split

On October 12, 2022, the Company filed a certificate of amendment to its certificate of incorporation with the Secretary of State of the State of Delaware to effect a 1-for-12.14 reverse stock split of its outstanding shares of common stock. As a result of the reverse stock split, every 12.14 shares of the Company’s outstanding pre-reverse split common stock were combined and reclassified into one share of common stock.

September 2021 Bridge Financing – The 12% Secured Convertible Bridge Notes and Warrants

From September 30, 2021 through October 20, 2021, our Board of Directors authorized purchasers (the “Purchasers”) to purchase for an aggregate price of up to $3,000,000 in subscription amount of convertible promissory notes (each a “12% Secured Convertible Bridge Note” and collectively, the “12% Secured Convertible Bridge Notes”) and warrants (each a “12% Secured Convertible Bridge Warrant” and collectively, the “12% Secured Convertible Bridge Warrants”) to purchase an aggregate of 449,304 shares of Common Stock pursuant to a securities purchase agreement (the “Securities Purchase Agreement”). The Company issued $1,000,000 worth of 12% Secured Convertible Bridge Notes and 12% Secured Convertible Bridge Warrants pursuant to the Securities Purchase Agreement to the Purchasers. The 12% Secured Convertible Bridge Notes accrue interest of twelve percent (12%), have a maturity date of March 30, 2023 (the “Maturity Date”) and the conversion price is equal to (i) if no initial public offering has occurred as of the conversion date, $6.68; (ii) if an initial public offering has occurred prior to the Maturity Date, subject to a maximum of $24.48, seventy five percent (75%) of the lower of either the offering price or the opening share price of the Common Stock on the date of such initial public offering; or (iii) a reset price (as further discussed in the Securities Purchase Agreement) will be applied, if the Company issues any shares of Common Stock, including instruments convertible into shares of Common Stock at a per share price or conversion price which is less than the exercise price of the 12% Secured Convertible Bridge Notes then the conversion price of the 12% Secured Convertible Bridge Notes will be reduced to the lower price then in effect. The 12% Secured Convertible Bridge Warrants are each five-year warrants to purchase shares of Common Stock, with a one-hundred percent coverage (100%), at an exercise price of $13.35 per share in connection with the Securities Purchase Agreement. The 12% Secured Convertible Bridge Warrants were issued to the Purchasers on September 30, 2021.

On July 29, 2022, the Company issued an additional $300,000 worth of 12% Secured Convertible Bridge Notes and 12% Secured Convertible Bridge Warrants pursuant to the Securities Purchase Agreement to the Purchasers. The $300,000 12% Secured Convertible Bridge Warrant have the same terms as described above and the $300,000 12% Secured Convertible Bridge Notes have the same terms as described above except the maturity date is January 29, 2024.

On October 19, 2022, all noteholders holding notes which do not mandatorily convert upon the closing of the IPO, executed note exchange agreements in which the holders agreed to exchange their notes for shares of Common Stock to be issued by the Company upon the effectiveness of the registration statement for the IPO. The notes shall be converted into an amount of shares of the Company’s common stock equal to the aggregate principal amount divided by the lower of either the price per share of the IPO or the conversion price set forth in the note. Interest due on these notes from June 30, 2022, to the date the closing of this offering will be paid in cash.

On November 17, 2022, the Company extended $17,000,917 in convertible notes which includes $140,761 of the $166,856 in convertible notes that were previously in default as of September 30, 2022. The notes were extended to February 17, 2023. The notes shall be converted into an amount of shares of the Company’s common stock equal to the aggregate principal amount divided by the lower of either the price per share of the IPO or the conversion price set forth in the note. The expiration date of the warrants related to these notes were extended to December 31, 2023. The Company also extended $388,455 in notes payable to February 17, 2023. As of the date of this filing, $585,568 in convertible notes are in default. As of the date of this filing, $76,560 in notes payable are in default.

On November 20, 2022, the Company issued a $14,357 12% Secured Convertible Note with 2,150 warrants. The note converts at $6.68 if no initial public offering has occurred as of the conversion date or 75% of either the offering price, the opening share price of the Company’s common stock on the date of the initial public offering, with a maximum of $24.28, or if any convertible securities are issued with a conversion price less than the conversion price of this note, then the conversion price will be equal to the conversion price of that convertible security. The notes are due in full on the maturity date of January 28, 2024.

December 2022 Bridge Financing – The 12% Secured Convertible Bridge Notes and Warrants

Our Board of Directors authorized purchasers to purchase for an aggregate price of up to $1,000,000 in subscription amount of convertible promissory notes (each a “December 2022 12% Secured Convertible Bridge Note” and collectively, the “December 2022 12% Secured Convertible Bridge Notes”) and warrants (each a “December 2022 12% Secured Convertible Bridge Warrant” and collectively, the “December 2022 12% Secured Convertible Bridge Warrants”) to purchase an aggregate of 200,000 shares of Common Stock pursuant to a securities purchase agreement dated December 1, 2022 (the “December 2022 Securities Purchase Agreement”). The Company issued $26,315 and $100,000 worth of December 2022 12% Secured Convertible Bridge Notes and December 2022 12% Secured Convertible Bridge Warrants on December 6, 2022 and December 30, 2022 respectively pursuant to the December 2022 Securities Purchase Agreement. The December 2022 12% Secured Convertible Bridge Notes accrue interest of twelve percent (12%), have a maturity date of June 1, 2023 and the conversion price is equal to 75% of the offering price of the Common Stock (or unit price, if units are offered in the initial public offering) on the date of such initial public offering. The December 2022 12% Secured Convertible Bridge Warrants are each five-year warrants to purchase shares of common stock, with a one warrant for every $5 in principal with an exercise price of, subject to adjustment as provided thereunder, 125% of the lower of either the offering price of the Common Stock (or unit price, if units are offered in the initial public offering) on the date of such initial public offering.

Results of Operations

Comparison of the three months ended December 31, 2022 and 2021

Revenues

During the three months ended December 31, 2022 and 2021, the Company’s revenue decreased to $475 from $1,093,004. This decrease was due to a decreased demand for COVID-19 Antigen (PCR) testing services through our UKAS accredited ISO 15189:2012 medical laboratory.

Cost of Sales 

During the three months ended December 31, 2022 and 2021, the Company’s cost of sales decreased to $40,505 from $484,077. This decrease was related to the decreased costs of reagents and consumables required to deliver COVID-19 testing services, which declined in the current period.

Research and Development

During the three months ended December 31, 2022 and 2021, the Company’s research and development expenses decreased to $100,629 from $535,225. This decrease was due to decreased research and development activities related to our candidate products.

General and Administrative Expenses

During the three months ended December 31, 2022 and 2021, the Company’s general and administrative expenses increased to $646,014 from $422,001. This increase was due to an increase in the use of contractors and consultants and reduced allocation of wages to cost of sales activity.

Interest Expense

During the three months ended December 31, 2022 and 2021, the Company’s interest expense related to debt decreased to $333,391 from $889,892. This decrease was due to finance costs incurred during the prior year three-month period, including Cantone fees and interest sweeteners.

During the three months ended December 31, 2022 and 2021, the Company’s interest expense related to related party debt increased to $107,545 from $97,466. This increase was due to the issuance of our additional 12% Secured Convertible Bridge Notes.

During the three months ended December 31, 2022 and 2021, the Company’s interest expense related to deferred compensation increased to $12,634 from $7,006. This increase was due to a reduction in deferred compensation.

During the three months ended December 31, 2022 and 2021, the Company’s amortization of debt discount decreased to $352,323 from $702,730. The decrease was due to the full amortization of some of the debt discounts within the prior fiscal year.

Net Loss

During the three months ended December 31, 2022 and 2021, the Company’s net loss decreased to $1,542,267 from $1,701,834. The decrease was primarily due to a decrease in Research & Development expenses and a decrease in interest expense.

Comparison of the years ended September 30, 2022 and 2021

Revenues

During the years ended September 30, 2022 and 2021, the Company’s revenue decreased to $1,554,697 from $3,602,296. This decrease was due to a decreased demand for COVID-19 Antigen (PCR) testing services through our UKAS accredited ISO 15189:2012 medical laboratory.

Cost of Sales 

During the years ended September 30, 2022 and 2021, the Company’s cost of sales decreased to $887,177 from $1,819,352. This decrease was related to the decreased costs of reagents and consumables required to deliver COVID-19 testing services, which declined in the current period.

Research and Development

During the years ended September 30, 2022 and 2021, the Company’s research and development expenses increased to $1,934,077 from $717,066. This increase was due to increased research and development activities related to our candidate products.

General and Administrative Expenses

During the years ended September 30, 2022 and 2021, the Company’s general and administrative expenses decreased to $1,906,523 from $2,084,864. This decrease was due to the implementation of cost cutting measures and a decrease in the use of contractors and consultants.

Interest Expense

During the years ended September 30, 2022 and 2021, the Company’s interest expense related to debt increased to $1,715,205 from $1,303,289. During the years ended September 30, 2022 and 2021, the Company’s interest expense related to related party debt increased to $423,884 from $344,688. This increase was due to the issuance of our additional 12% Secured Convertible Bridge Notes.

During the years ended September 30, 2022 and 2021, the Company’s interest expense related to deferred compensation decreased to $2,729 from $19,166. This decrease was due to a reduction in deferred compensation.

During the years ended September 30, 2022 and 2021, the Company’s amortization of debt discount increased to $1,016,034 from $206,693. The increase was due to the increase in debt discount due to the sweetener on the notes and the derivative liability leading to an increase in the amortization expense.

Net Loss

During the years ended September 30, 2022 and 2021, the Company’s net loss increased to $6,065,868 from $2,999,522. The increase was primarily due to a decrease in revenue resulting from COVID testing revenue and an increase in R&D expenses. 

Liquidity and Capital Resources

As of December 31, 2022, we had $219,536 in cash, and as of September 30, 2022, we had $38,239 in cash. We will require significant amounts of additional capital to continue to fund our operations and commence and complete our research and development activities. We currently have limited resources to continue to fund our operations and if we are not able to obtain additional cash resources, we will not be able to continue operations. We will continue seeking additional financing sources to meet our working capital requirements, make continued investment in research and development and make capital expenditures needed for us to maintain and expand our business. We may not be able to obtain additional financing on terms favorable to us, if at all. If we are unable to obtain adequate financing or financing on terms satisfactory to us when we require it, or if we expend capital on projects that are not successful, our ability to continue to support our business growth and to respond to business challenges could be significantly limited, or we may even have to cease our operations. If we raise additional funds through further issuances of equity or convertible debt securities, our existing shareholders could suffer significant dilution, and any new equity securities we issue could have rights, preferences and privileges superior to those of holders of our Common Stock, including shares of Common Stock sold in this offering.

Funding Requirements

Our primary use of cash is to fund operating expenses, which consist of research and development expenditures and various general and administrative expenses. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.

Because of the numerous risks and uncertainties associated with research, development and commercialization of diagnostic products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:

We will need additional funds to meet our operational needs and capital requirements for clinical validations, other research and development expenditures, and general and administrative expenses. We currently have no credit facility or committed sources of capital.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

 For the Three Months Ended December 31, 2022 and 2021

We have incurred substantial operating losses since inception and expect to continue to incur significant operating losses for the foreseeable future. As of December 31, 2022, we had an accumulated deficit of $54,053,503. The Company has incurred recurring losses and the Company expects to continue to incur losses as a result of costs and expenses related to the Company’s clinical development and corporate general and administrative activities. We had a working capital deficit of $26,311,952 as of December 31, 2022.

Our financial statements have been prepared assuming that we will continue as a going concern.

Operating activities provided $172,208 and used $373,291 in cash for three months ended December 31, 2022 and 2021, respectively. The use of cash in operating activities during the three months ended December 31, 2022, primarily comprised of $1,542,267 net loss, $88,396 in depreciation and amortization, $352,323 in amortization of debt discount, an increase in accrued interest of $263,692, an increase in related party accrued interest of $109,673, a $311,974 increase of deferred compensation, and an increase of $363,842 in research tax credit receivable. The use of cash in operating activities during the three months ended December 31, 2021, primarily comprised of $1,701,834 net loss, $105,568 in depreciation and amortization, an increase in accrued interest of $301,337, an increase in related party accrued interest of $155,612, a $784,239 increase of deferred compensation, and a decrease of $299,111 in accounts payable and accrued expenses.

Investing activities used $38,702 and $0 in cash for the three months ended December 31, 2022 and 2021, respectively. The use of cash in investing activities was due to the purchase of fixed assets for the three months ended December 31, 2022.

Financing activities provided $140,673 and $300,000 in cash three months ended December 31, 2022 and 2021. The cash provided by operations for the three months ended December 31, 2022 and 2021 came from proceeds from convertible notes payable.

For the Years Ended September 30, 2022 and 2021

We have incurred substantial operating losses since inception and expect to continue to incur significant operating losses for the foreseeable future. As of September 30, 2022, we had an accumulated deficit of $52,287,747. The Company has incurred recurring losses and the Company expects to continue to incur losses as a result of costs and expenses related to the Company’s clinical development and corporate general and administrative activities. We had a working capital deficit of $24,921,647 as of September 30, 2022.

Our financial statements have been prepared assuming that we will continue as a going concern.

Operating activities used $1,924,329 and $557,417 in cash for years ended September 30, 2022 and 2021, respectively. The use of cash in operating activities during the year ended September 30, 2022, primarily comprised of $6,065,868 net loss, $356,539 in depreciation and amortization, $1,016,034 in amortization of debt discount, an increase in accrued interest of $1,231,525, an increase in related party accrued interest of $369,496, a $671,433 increase of deferred compensation, and an increase of $363,842 in research tax credit receivable. The use of cash in operating activities during the year ended September 30, 2021, primarily comprised of $2,999,522 net loss, $348,139 in depreciation and amortization, $269,925 from interest expense related to the sweetener on capitalized interest, an increase in accrued interest of $1,010,372, an increase in related party accrued interest of $252,117, a $239,050 increase of deferred compensation, and a decrease of $232,420 in research tax credit receivable.

Investing activities used $26,781 and $63,932 in cash for the years ended September 30, 2022 and 2021, respectively. The use of cash in investing activities was due to the purchase of fixed assets for the years ended September 30, 2022 and 2021.

Financing activities provided $780,757 and $1,529,810 in cash years ended September 30, 2022 and 2021. The cash provided by operations for the year ended September 30, 2022 came from proceeds from convertible notes payable of $1,188,942, deferred offering costs of $292,749, and financing fees paid of $145,852. The cash provided by operations for the year ended September 30, 2021 came from proceeds from convertible notes payable of $1,222,341, proceeds from related party convertible notes payable of $629,894, and financing fees paid of $322,425.

Recent Accounting Pronouncements Not Yet Adopted

See Note 3 to our financial statements for the three months ended December 31, 2022 included elsewhere in this prospectus for more information.

Critical Accounting Policies and Estimates

Research and Development

We incur research and development costs during the process of researching and developing our technologies and future offerings. We expense these costs as incurred unless such costs qualify for capitalization under applicable guidance.

Foreign Currency Translation

The Company follows Section 830-10-45 of the FASB Accounting Standards Codification (“Section 830-10-45”) for foreign currency translation to translate the financial statements of the foreign subsidiary from the functional currency, generally the local currency, into U.S. Dollars. Section 830-10-45 sets out the guidance relating to how a reporting entity determines the functional currency of a foreign entity (including of a foreign entity in a highly inflationary economy), re-measures the books of record (if necessary), and characterizes transaction gains and losses. Pursuant to Section 830-10-45, the assets, liabilities, and operations of a foreign entity shall be measured using the functional currency of that entity. An entity’s functional currency is the currency of the primary economic environment in which the entity operates; normally, that is the currency of the environment, or local currency, in which an entity primarily generates and expends cash.

The functional currency of each foreign subsidiary is determined based on management’s judgment and involves consideration of all relevant economic facts and circumstances affecting the subsidiary. Generally, the currency in which the subsidiary transacts a majority of its transactions, including billings, financing, payroll and other expenditures, would be considered the functional currency, but any dependency upon the parent and the nature of the subsidiary’s operations must also be considered. If a subsidiary’s functional currency is deemed to be the local currency, then any gain or loss associated with the translation of that subsidiary’s financial statements is included in accumulated other comprehensive income. However, if the functional currency is deemed to be the U.S. Dollar, then any gain or loss associated with the re-measurement of these financial statements from the local currency to the functional currency would be included in the consolidated statements of operations and comprehensive income (loss). If the Company disposes of foreign subsidiaries, then any cumulative translation gains or losses would be recorded into the consolidated statements of operations and comprehensive income (loss). If the Company determines that there has been a change in the functional currency of a subsidiary to the U.S. Dollar, any translation gains or losses arising after the date of change would be included within the consolidated statements of operations and comprehensive income (loss).

Based on an assessment of the factors discussed above, the management of the Company determined its subsidiary’s local currency (the British Pound) to be the functional currency for its foreign subsidiary.

Stock-Based Compensation

The Company accounts for stock-based compensation costs under the provisions of ASC 718, Compensation—Stock Compensation, which requires the measurement and recognition of compensation expense related to the fair value of stock-based compensation awards that are ultimately expected to vest. Stock based compensation expense recognized includes the compensation cost for all stock-based payments granted to employees, officers, and directors based on the grant date fair value estimated in accordance with the provisions of ASC 718. ASC 718 is also applied to awards modified, repurchased, or cancelled during the periods reported. Stock-based compensation is recognized as expense over the employee’s requisite vesting period and over the nonemployee’s period of providing goods or services.

The Company utilizes the Black Scholes valuation model to value the issuance of options and warrants. Forfeitures of stock options and warrants are recognized as they occur.  The inputs used in the Black Scholes model are as follows:

Stock Price: The Company has conducted a 409A analysis to determine the fair value of its stock.

Risk-free interest rate: The Company uses the risk-free interest rate of a U.S. Treasury Note with a similar expected term on the date of measurement.

Expected term: The Company uses the simplified method to calculate the expected term of share options and similar instruments as the Company does not have sufficient historical data to provide a reasonable basis upon which to estimate the expected term.

Volatility: The Company calculates the expected volatility of the stock price based on the corresponding volatility of the Company’s peer group stock price for a period consistent with the instrument’s expected term.

Fair value of Common Stock

In order to determine the fair value of shares of our Common Stock, given the absence of a public trading market of our capital stock to date, the Company has exercised reasonable judgment and considered a number of objective and subjective factors to determine the best estimate of the fair value of our Common Stock, including:

In estimating the fair market value of our Common Stock, the Company first determined the equity value of our business using accepted valuation methods.

 Revenue Recognition

In accordance with ASC 606, revenue is recognized when a customer obtains control of promised services. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for these services. To achieve this core principle, the Company applies the following five steps:

Derivative Liability

The Company evaluates its financial instruments to determine if those contracts or embedded components of those contracts qualify as derivatives to be accounted for separately. In circumstances where the embedded conversion option in a convertible instrument is required to be bifurcated and there are also other bifurcated embedded derivative instruments in the convertible instrument, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument. The result of this accounting treatment is that the fair value of the embedded derivative is recorded as a liability and marked-to-market each balance sheet date, with the change in fair value recorded in the statements of operations as other income or expense.

Accounts Receivable and Allowance for Doubtful Accounts

Accounts receivable are stated at the amount management expects to collect from outstanding balances. The Company generally does not require collateral to support customer receivables. The Company determines if receivables are past due based on days outstanding, and amounts are written off when determined to be uncollectible by management. As of December 31, 2022 and September 30, 2022, there was no allowance for doubtful accounts deemed necessary.

Intangible Assets

Intangible assets consist of patents and are stated at cost less accumulated amortization. The patents are amortized using the straight-line method over the patents remaining life until the expiration date of the patent.

The Company incurs fees related to patents, consisting of costs to defend patents, acquire new patents, and renew or extend the term of existing patents, which are expensed as incurred.

The JOBS Act and Emerging Growth Company Status

Section 107 of the JOBS Act also 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 elected to avail ourselves of this extended transition period.

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

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,” including the extension of time to comply with new or revised financial accounting standards available under Section 102(b) of the JOBS Act. 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 you with 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.

BUSINESS

Overview

MDNA Life Sciences Inc. is pioneering the development of molecular tests based on the mitochondrial genome in order to improve clinical insight and therapeutic decisions that affect patients worldwide. Though further technical development and clinical validation is required to determine efficacy in multiple diseases and disease states, our management believes that the unique structural and functional characteristics of mitochondrial DNA (mtDNA), and more specifically mutated mtDNA, make mtDNA a biological system for biomarker identification, early disease detection, monitoring, risk assessment, and therapeutic targeting.

We acquired the assets of Mitomics Inc. on November 17, 2014. Through the acquisition of these assets, and in particular the Mitomic Technology platform, patents, and intellectual property, our management believes that the Company is well positioned for research and discovery of mitochondrial DNA based biomarkers, and though untested and requiring clinical validation, the development and commercial application of mitochondrial DNA based biomarkers for a wide spectrum of human diseases. This acquisition included a scientific team with expertise in the field of mitochondria and mitochondrial DNA.

We are continuing to leverage this scientific expertise to discover mitochondrial DNA based biomarkers. Though we have no commercially available FDA or foreign regulator approved products, the Company has two product candidates in develop and hopes to enter the cancer screening market with these two product candidates, and if proven successful continue to discover mitochondrial DNA based biomarkers and develop a pipeline of disease screening and diagnostics tests. The current in-development products include a potential product for prostate cancer diagnosis and a potential product for the detection of endometriosis. The Company has also discovered mitochondrial DNA based biomarkers, which it believes are associated with ovarian cancer and lung cancer; and the Company intends to pursue the biomarker identification phase of development for pancreatic, liver, breast, stomach, esophageal, and colorectal cancers.

We have licensed our intellectual property related to the Mitomic prostate cancer biomarker through a license and distribution agreement with Laboratory Corporation of America Holdings (“LabCorp”) a national US commercial Clinical Laboratory Improvement Amendments (“CLIA”) lab in the United States. The LabCorp Agreement was executed on December 22, 2017 and amended on May 20, 2019 and November 13, 2019 (the “LabCorp Agreement”), under the most recent amendment to the LabCorp Agreement, commencement is the date of commercial launch, upon such time, the LabCorp Agreement has a term of five years. The commencement date, defined as the commercial launch date (the “Commercial Launch Date”) means the date on which LabCorp makes licensed services generally available to its customers (excluding research and development, validation work, or testing performed in connection with clinical studies or clinical trials). The LabCorp Agreement’s term will not commence until LabCorp successfully validates an in vitro diagnostic test using the licensed intellectual property related to the Mitomic prostate cancer biomarker, classified as a Laboratory Developed Test (LDT) per the FDA and Centers for Medicare and Medicaid Services (CMS) guidance. The parties may agree to extend the term for one or more additional periods. Pursuant to the terms of the LabCorp Agreement, MDNA will grant LabCorp a license to use certain licensed patents to conduct research and development for commercial purposes, limited to testing in connection with clinical studies on prostate cancer. LabCorp will have exclusive rights to the licenses in certain areas. LabCorp shall make the following license and royalty payments for such licenses.

The upfront license fee for the LabCorp Agreement is $250,000 and additional license fee payable on the commencement date is $250,000. LabCorp shall pay minimum annual royalties for each contract year, which shall be $1,000,000 for year 1 and increase by $1,000,000 each year thereafter until reaching $5,000,000 on year 5. LabCorp will pay the Company running royalties equal to 10% of its net sales during the term of the LabCorp Agreement. Minimum annual royalties will be fully creditable towards the running royalties. The aggregate amount of all potential milestone payments is $8,500,000.

The LabCorp Agreement may be terminated upon written notice by (a) LabCorp at any time prior to the commercial launch date in the event LabCorp reasonably believes the preliminary studies did not achieve the desired outcomes as outlined in the LabCorp Agreement; (b) LabCorp at any time and for any reason upon 180 days’ notice; (c) either party because of a material breach; or (d) LabCorp upon a change of control. Payment under the LabCorp Agreement is not due until the commercial launch date as described more fully in the LabCorp Agreement. Our liquid biopsy portfolio covers many high-clinical need cancers, with potential applications outside oncology.

PRODUCT PORTFOLIO AND PIPELINE OVERVIEW

As noted herein, the Company has discovered mitochondrial DNA based biomarkers, which it believes are associated with ovarian cancer and lung cancer; and the Company hopes to be able to continue to discover mitochondrial DNA based biomarkers associated with other cancers. Our Company has created a database of proprietary mitochondrial DNA based biomarkers discovered by our internal scientific team. Given our internal scientific team’s experience in the discovery of proprietary mitochondrial DNA based biomarkers and their research relating to the molecular genetics of the mitochondrial genome and its potential application to disease detection, we believe we are positioned, if technically and clinically successful, to carry out the development of products that address well-defined clinical needs in a non-invasive cost-effective manner.

We are committed to providing improvement in clinical outcomes where current technologies do not allow for non-invasive or mildly invasive testing at an early stage of disease progression.

We have a deep pipeline of product candidates focused on high burden diseases, which is highlighted in the chart below. MDNA has identified that these diseases have a significant unmet clinical need and it is our intent to pursue the successful development of diagnostic tests based on proprietary biomarkers for these indications.

MDNA’s product development pathway includes four phases. The biomarker identification phase aims to determine whether mitochondrial genome mutations can be detected and correlated with the presence or absence of disease. This phase utilizes methodology capable of cataloguing the mitochondrial DNA mutations across multiple samples at high resolution. This methodology is ideal for discovery but differs from the planned detection method of the products which is capable of higher throughput and is far more cost effective. Where candidate biomarkers are identified, this phase includes the first transition of the detection method to the anticipated method of the product and a preliminary assessment of clinical performance. The selection of candidate biomarkers as an output of this phase relies on the totality of evidence. These candidate biomarkers are then further evaluated and validated during the phases of assay development and analytical validation, wherein the specification of the assay and methods are defined and measured, and clinical validation, where clinical performance is measured. Finally, where the final product form is device, design transfer is completed, and commercial lot manufacturing commences.

Biomarker identification studies generally rely upon clinical samples retrospectively selected by outcome from tissue banks as is the case for each of these proof of concept studies to identify candidate biomarkers of disease. These generally include 50-100 patient samples with known outcomes to mine for biomarkers. The candidate biomarkers identified for the Company’s Ovarian Cancer and Lung Cancer products followed this strategy. The biomarkers for endometriosis and prostate cancer, while later in development were first identified in the same manner.

The first prospective clinical study for MPT included 218 participants with a total PSA less than 10 ng/ml. This study met its primary endpoint of prediction of clinically significant prostate cancer which was defined as Gleason Score 7 or greater on prostate biopsy. Specifically, the assay was a good predictor of CS PCa in an image-guided re-biopsy population [Area Under the Curve (AUC) 0.84, (95% CI 0.73–0.95)]. The data points of the Receiver Operating Characteristic Curve (ROC) were used to identify an optimal threshold at which to separate the patient values into disease and non-disease group. At the selected threshold the sensitivity was 87% [95% CI, 70–96%], specificity of 68% [95% CI, 47–85%] and negative predictive value (NPV) of 97%. Applying this threshold to the second population of men who had not had a previous negative prostate biopsy (biopsy naïve at time of blood collection) showed this deletion to be a strong predictor of CS cancer [AUC 0.98, (95% CI 0.94–1.02)], [sensitivity 100% (95% CI, 93–100%), specificity 90% (95% CI 73–98%) and NPV 100%]. Confidence intervals and significance levels quantify the statistical uncertainty in these estimates due to the subject/sample selection process. This type of uncertainty decreases as the number of subjects in the study increases. Confidence intervals (CI) are used to test the hypothesis and are the range of values that you would expect your estimate to fall within if the test was repeated with a certain level of confidence, in this case, 95%. Mean differences between case and control groups were significant, p < 0.0001. A p value < 0.05 was considered statistically significant for all tests. The p value is the probability under a specified statistical model that a statistical summary of the data (for example, the sample mean difference between two compared groups) would be equal to or more extreme than its observed value. The lower the p value the greater the statistical significance of the observed data. A p value threshold of 0.05 is the standard recognized by FDA.

Receiver operating characteristic (ROC) curve is the plot that depicts the trade-off between the sensitivity and (1-specificity) across a series of cut-off points when the diagnostic test is continuous or on ordinal scale (minimum 5 categories).

The area under an ROC curve (AUC) is a measure of the usefulness of a test in general, where a greater area means a more useful test, the maximum AUC is 1.0.

A diagnostic threshold is the point objectively selected to correspond to the optimal clinical use of the test in an intended population. In diagnostics, this is frequently the point where the probability of classifying a patient into disease positive or disease negative is the highest.

Secondary endpoints included absence of correlation with total PSA and patient age, both of which were met. These data support the potential for MPT biomarkers detected in blood to guide the decision to biopsy for patients suspected of prostate cancer with a total PSA in the ‘grey zone’, and provide clinicians with a measure of an independent predictor of prostate cancer unrelated to PSA.

The first prospective study for MET included 182 participants with suspected endometriosis scheduled for first diagnostic laparoscopy. This study met is primary endpoint of prediction of surgical outcome of endometriosis. Discrimination between symptomatic control and all endometriosis specimens using the 8.7kb assay was achieved with an AUC of 0.80, (95% CI 0.7035–0.8979), p < 0.0001, where p < 0.05 was considered statistically significant. Secondary endpoints included correlation with different stages of disease (Stage 1-4, increasing in severity), stage groups (low stage – Stage 1 and 2, high stage – Stage 3 and 4), different disease subtypes (primary peritoneal, endometrioma, deep infiltrating endometriosis), phase of menstruation at time of blood collection, hormone status, and patient age. MET predicted low stage and peritoneal disease most accurately, and high stage and deep infiltrating endometriosis least accurately. No significant correlation was observed between phase of menstruation, hormone status nor patient age. These data support the potential for MET biomarkers detected in blood to provide a low risk, quantitative measure of a patient’s probability of an endometriosis diagnosis without immediately undergoing surgery. Patients could be more rapidly identified for interventions appropriate for earlier, lower risk treatment of endometriosis before the risk of an invasive procedure is warranted. The blood-based matrix for the test allows for use earlier in the clinical pathway where a greater proportion of affected patients can benefit.

Management believes the Company has a number of operational advantages that have the potential to support long term growth and competitive advantage.

Our operational advantages fall within a number of broad categories and include, but are not limited to:

We believe our Mitomic Technology may be a shift in the scientific approach to biomarker identification, which we also believe represents a potential, though unproven opportunity for new biomarker identification and molecular diagnostic development and commercialization.

Our core asset – the MDNA Mitomic Technology biomarker engine – is, in our opinion, an effective biomarker identification platform which is supported by published analytical biomarker data. Currently, the Mitomic Technology platform has an “in silico” database, which is an experiment that generates thousands of potential biomarkers (developed by using computer software and simulation). Critical to the success of the database is our internal science team’s previous discoveries of mitochondrial DNA biomarkers.

To date, the MDNA biomarker engine has identified mitochondrial DNA based biomarker targets from the in silico database; and the Company’s scientific team has used these targets to discover proprietary mitochondrial DNA based biomarkers that are currently under development within our product development program. Management believes that the Mitomic Technology platform is well-designed to identify proprietary mitochondrial DNA based biomarker targets, that can be used in future product candidates. Importantly, the previously discovered proprietary mitochondrial DNA based biomarkers have been developed into blood-based, liquid biopsy molecular assays, supported by published analytical data, for the identification of prostate cancer and for the identification of endometriosis. Further proof of concept work by the Company has shown the success of the Mitomic Technology platform for detecting proprietary mitochondrial DNA based biomarkers that we believe are associated with ovarian cancer and lung cancer.

The technology platform and biomarker identification program is based on the identification of a new class of molecules generated through a process associated specifically with mitochondria.

Mitochondrial DNA is a powerful biosensor of cell health and disease due to its unique biological features and advantages over nuclear DNA. Mitochondrial DNA is present in very high copy numbers per cell, mutates frequently in response to disease induced stress, lacks repair mechanisms, and its mutations accumulate without causing cell death. The resulting disease specific mutations are detectable using standard molecular laboratory techniques in bodily fluids and blood; and subject to further clinical validation, these disease specific mutations may occur before typical clinical evidence of disease is present. Though untested and subject to clinical study and validation, these biological features may enable sensitive and specific early detection of disease. A summary of these biological features and potential clinical benefits thereof is illustrated below:

A recent review article in the journal Radiology noted that emerging imaging techniques now enable more precise molecular characterization of tumors; however, multigenetic tumor profiling for diagnostic and therapeutic selection remains limited due to the tissue sample requirement. The authors note that an alternative to tissue acquisition is the collection of circulating tumor markers, such as cell-free nucleic acids and circulating tumor cells in the peripheral blood. Similarly, another review article notes that the minimally invasive nature of liquid biopsy for malignancy without the delay, cost, and risk associated with tissue biopsy, potentially at a microscopic stage before radiologic detectability, is a promising advantage for cancer screening.

Circulating biomarkers including cell free DNA, circulating tumor DNA, and circulating tumor cells can serve as non-invasive tests for screening, diagnosis, prognosis, and therapy guidance for many solid tumors. Of particular interest, circulating cell-free DNA can be found in plasma. The levels of cell free DNA can be elevated in a variety of settings including cancer. In the setting of cancer, a portion of the cell free DNA contains tumor specific characteristics which can be distinguished from normal cell-free DNA by the presence of mutations concordant with the tumor of origin. This is precisely how our Mitomic Technology designed to work. MicroRNA, tumor-educated platelets, and tumor-derived exosomes are additional biomarkers that show promise but remain early in development.

Importantly, a number of circulating biomarkers are being investigated, from cell-free DNA, CTCs, circulating microRNAs and other biomarkers, for the development of tests for early cancer detection. Cell free DNA of nuclear and mitochondrial origin seem to have an advantage in cancer screening compared to other biomarkers by showing better efficiency. In our opinion, circulating tumor DNA and cell free DNA offer the most developed utilities with little to no disadvantages.

A summary of the biomarkers for liquid biopsy and their advantages and disadvantages can be found below:

Techniques to analyze cell free DNA include several polymerase chain reaction (“PCR”)–based methods and next-generation sequencing (“NGS”). For the Company, following biomarker identification and selection, the MDNA biomarker engine reduces each biomarker to quantitative, real-time PCR (“rtPCR”) or digital PCR (“dPCR”) assays. This PCR technology has proven to be sensitive, specific and reliable, and historically has been used in clinical settings for the diagnosis of disease and monitoring disease progression during the course of therapy. PCR technology has formed the basis of many FDA-approved clinical diagnostic assays; these assays are less labor-intensive than other molecular testing procedures and they are highly amenable to automation. This saves time and money during the test development phase and in the operations of the research laboratory. Another advantage of PCR based assays over NGS is its lower cost and implementation. A summary and comparison of NGS and PCR techniques, as documented by Liquid Biopsy for Cancer: Review and Implications for the Radiologist, is found in the table below:

Mitochondrial genomics has potential, in our opinion, because readily obtained blood samples, , as supported by published analytical data, contain high quantities of disease associated biomarkers that can be quantified using quantitative real-time or digital PCR assays at a lower cost compared to traditional NGS genomic testing panels.

Commercialization Strategy

Our commercialization strategy in the US for all products anticipates first market entry via out-licensing of our intellectual property to a third-party laboratory to market an in vitro diagnostic test, classified as a Laboratory Developed Test (LDT) per Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) guidance. In the US, CMS regulates all laboratory testing except for research performed on humans through the Clinical Laboratory Improvement Amendments (CLIA), with the objective to ensure quality in laboratory testing. Where FDA regulates device manufacturers marketing in vitro diagnostic devices, CMS regulates laboratories that perform testing on patient specimens.

The LDT pathway shares many similarities with the FDA premarket clearance or approval pathway in that performance of the test must be demonstrated with sufficient evidence to support its validity. This performance must be documented within the laboratory’s quality system and available for review and audit. In contrast, the FDA premarket clearance pathway requires that the documentation is submitted, reviewed, and approved before marketing the product. For LDT’s, the documentation is not generally reviewed until the provider’s next biannual survey by CMS. Additionally, CMS does not review clinical performance, only analytical performance. The totality of test performance is the responsibility of the Laboratory Director.

Management may re-evaluate the suitability of the LDT regulatory pathway for any of its portfolio in consideration of but not limited to patient access, market conditions, regulatory guidance, and life span of the associated intellectual property, to pursue FDA clearance.

Similarly, outside of the US in many countries including the UK and Europe, clinical laboratories accredited to ISO 15189:2012 for Medical Laboratories may offer In-House In Vitro Diagnostic Devices (ID-IVD) as defined by the (EU) 2017/746 (IVDR), or by other country-specific regulation. Laboratories holding this accreditation may provide diagnostic testing using test systems developed within the laboratory in adherence with the requirements of the applicable regulation, the ISO standard, and the laboratory’s quality system. Test performance must be established and both analytical and clinical performance are typically reviewed by an external accreditation agency coincident with the first marketing of the test. The IH-IVD strategy is intended to provide patients access to the test once performance has been validated while the development of in vitro diagnostic kits, including CE-IVD marked, are pursued in parallel.

The marketing of in vitro diagnostic kits in the EU and other markets typically requires a conformity assessment by an external notified body prior to making a declaration of conformity and marketing the device. For the EU, this review process is currently anticipated to be lengthy as a result of the transition to the IVDR from IVDD in May of 2022 and the resultant excess of submissions to be reviewed by the few eligible Notified Bodies currently designated under IVDR.

Barriers to Entry

Though our industry, broadly speaking, has a number of competitors – large and small – with new entrants appearing regularly, in the Company’s opinion, there is one primary barrier to entry in our favor that is coupled with an important ancillary barrier to entry. These barriers to entry include:

Intellectual Property and Patents

We have an intellectual property portfolio related to the application of mitochondrial mutations to disease detection. This portfolio consists of multiple elements including: (i) issued and allowed patents; (ii) pending patent applications; plus (iii) trade secrets, proprietary databases, software and know-how.

We vigorously pursue a global intellectual property protection strategy for our biomarker innovations. This primarily involves obtaining or pursuing patent protection in several key jurisdictions, including but not limited to the US, Canada, Australia, Europe, China, India, Singapore, New Zealand, Japan, South Korea, and Hong Kong. In view of the subject matter being protected, the scope of each MDNA patent application is tailored to meet local patentability requirements. Thus, in Europe, for example, we protect diagnostic methods and diagnostic kits we have developed related to unique biomarkers. 

For patent protection of new intellectual property, we currently file initial provisional patent applications in the US Patent Office followed by PCT applications to preserve the ability to attempt to secure protection in jurisdictions outside the United States.

Patents in MDNA’s portfolio continue to age with remaining life span ranging from approximately 3 years to 17 years, seven of the nine patent families expire within the next 6 years. These seven patent families include claims relevant to the Mitomic® Prostate Test as well as composition of matter and methods claims for breast cancer assays. Our patent relating to endometriosis expires within 17 years. Expiration of patents negatively impacts the ability to license the patent rights directly as well as enforce our rights against competitors. Competitors may reverse-engineer our products and compete directly with us in any market where a patent is no longer in force. This may require MDNA to reduce the sales price of existing products to remain competitive, invest in further research and development to improve product performance and obtain new patent protection, and/or expend additional funds on marketing to promote brand loyalty. Where possible, MDNA endeavors to extend the patent life supporting each of its commercial products through subsequent patent applications. Commercial products will include intellectual property in the form of trade secret and know-how however this alone cannot protect against competitors designing new products directed to our patented composition of matter and/or diagnostic methods upon expiration of said patents.

List of Patent Matters: