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Item 1A. Risk Factors

2021-03-31 compared with 2020-03-16 · 284 added, 478 removed, 147 unchanged (84% of the section changed)

An investment in our common stock involves a high degree of risk.

You should carefully consider the risks described below and the other information before

deciding to invest in our common stock.

You should carefully consider the risks described below and the other information before deciding to invest in our common stock.

The risks described below are not the only ones facing our Company.

Additional risks not presently known to us or that we currently consider immaterial may also adversely affect our business.

We have attempted

to identify below the major factors that could cause differences between actual and planned or expected results, but we cannot assure you that we have identified all of those factors.

We have attempted to identify below the major factors that could cause differences between actual and planned or expected results, but we cannot assure you that we have identified all of those factors.

If any of the following risks actually happen, our business, financial condition and operating results could be materially adversely affected.

In this case,

the trading price of our common stock could decline, and you could lose all or part of your investment.

In this case, the trading price of our common stock could decline, and you could lose all or part of your investment.

Risks Related to Our Company

We have incurred net losses to date and must raise additional capital in order to continue to operate after September 30, 2021.

We have incurred net losses to date and must raise additional capital in order to continue to operate.

We have incurred net losses in each year of operation since our inception in July 2000 and have no revenues.

Our accumulated deficit as of December 31,

2019 was $216.4 million.

Our accumulated deficit as of December 31, 2020 was $240 million.

We had $27.1 million of unrestricted cash as of December 31, 2020.

In December 2018, the Company announced an extension of its $10 million unsecured line of credit facility with stockholder and director,

The Company believes there is sufficient cash, including availability of the line of credit, to fund currently planned operations at least through September 30, 2021.

We will require more cash to fund our operations

after September 30, 2021 and believe we will be able to obtain additional financing.

The currently planned operations include costs related to a planned adaptively designed Phase 2b/3 clinical trial.

While the costs of the trial and general

overhead during and through the interim efficacy analysis of the first stage of the trial are currently estimated to be approximately $125 million, the costs and timing of such trial are not yet finalized.

The Company has not made commitments

for such trial that cannot be covered with available cash, but we will require additional funding in order to complete the trial.

However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that

such financing will be on terms favorable to us.

We may raise capital through public or private equity financings, partnerships, debt financings, bank

borrowings, or other sources.

In December 2018, the Company announced an extension of its, as yet untapped, $10 million unsecured line of credit facility with stockholder and director, Richard E.

The Company believes there is sufficient cash, including availability of the line of credit, to fund currently planned operations at least through March 31, 2022.

We will require more cash to fund our operations after March 31, 2022 and believe we will be able to obtain additional financing.

However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.

We may raise capital through public or private equity financings, partnerships, debt financings, bank borrowings, or other sources.

Additional funding may not be available on favorable terms or at all.

Our most recent significant financing, a rights offering closing in 2019 in which the Company raised $44.9 million, was led by our Chairman,

Our most recent significant financing, a rights offering closing in 2019 in which the Company raised $44.9 million, was led by our Chairman, Richard E.

Uihlein, who invested $20 million in the offering.

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Uihlein exercised 500,000 common stock warrants for cash proceeds to the Company of $2.5 million.

There is no assurance as to the level of

future investments to be made in the Company by Mr.

Though his investments in the Company and the line of credit that he extended to the Company, Mr.

Uihlein has been a critical source of funding.

There is no assurance as to the level of future investments to be made in the Company by Mr.

If adequate funds are not otherwise available, we may need to significantly curtail operations.

To obtain additional funding, we may need to enter into arrangements that require us to

relinquish rights to certain technologies, products and/or potential markets.

To the extent that additional capital is raised through the sale of equity, or securities convertible into equity, our equity holders may experience dilution of their

proportionate ownership of the Company.

To obtain additional funding, we may need to enter into arrangements that require us to relinquish rights to certain technologies, products and/or potential markets.

To the extent that additional capital is raised through the sale of equity, or securities convertible into equity, our equity holders may experience dilution of their proportionate ownership of the Company.

We are a development stage company and have not yet generated any revenue.

We are a development stage company and have not generated any revenues to date.

There is no assurance that we will obtain FDA approval of GR-MD-02 or any other of our products in development and, even if we do so, that we will generate revenue sufficient to become profitable.

Our failure to generate revenue and

profit would likely lead to loss of your investment.

Our ability to generate revenue from product sales and achieve profitability will depend upon our

ability to successfully commercialize products, including any of our current product candidates, or other product

candidates that we may in-license or acquire in the future.

Even if we are able to successfully achieve regulatory approval for these product candidates,

we do not know when any of these products will generate revenue from product sales for us, if at all.

Our ability to generate revenue from product sales from our current or future product candidates also depends on a number of additional factors,

including our ability to:

There is no assurance that we will obtain FDA approval of belapectin or other products that we may develop, and, even if we do so, that we will generate revenue sufficient to become profitable.

Our failure to generate revenue and profit would likely lead to loss of your investment.

Our ability to generate revenue from product sales and achieve profitability will depend upon our ability to successfully commercialize products, including our lead product candidate, or other product candidates that we may in-license

or acquire in the future.

Even if we are able to successfully achieve regulatory approval for these product candidates, we do not know when any of these products will generate revenue from product sales for us, if at all.

Our ability to generate revenue from product sales from our current or future product candidates also depends on a number of additional factors, including our ability to:

successfully complete development activities, including the necessary clinical trials;

complete and submit new drug applications, or NDAs, to the U.S.

Food and Drug Administration, or FDA, and obtain

regulatory approval for indications for which there is a commercial market;

Food and Drug Administration, or FDA, and obtain regulatory approval for indications for which there is a commercial market;

complete and submit applications to, and obtain regulatory approval from, foreign regulatory authorities;

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obtain commercial quantities of our products at acceptable cost levels;

find suitable distribution partners to help us market, sell and distribute our approved products in other

find suitable distribution partners to help us market, sell and distribute our approved products in other markets;

obtain coverage and adequate reimbursement from third parties, including government and private payers.

In addition, because of the numerous risks and uncertainties associated with product development, including that our product candidates

may not advance through development or achieve the endpoints of applicable clinical trials, we are unable to predict the timing or amount of increased expenses, or when or if we will be able to achieve or maintain profitability.

Even if we are able

to complete the development and regulatory process for any product candidates, we anticipate incurring significant costs associated with commercializing these products.

If we are unable to generate revenues from the sale of our products, we may not become profitable and may need to obtain additional funding to continue

In addition, because of the numerous risks and uncertainties associated with product development, including that our product candidates may not advance through development or achieve the endpoints of applicable clinical trials, we are unable to predict the timing or amount of increased expenses, or when or if we will be able to achieve or maintain profitability.

Even if we are able to complete the development and regulatory process for any product candidates, we anticipate incurring significant costs associated with commercializing these products.

If we are unable to generate revenues from the sale of our products, we may not become profitable and may need to obtain additional funding to continue operations.

If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations.

We are dependent on the success of our lead product candidate, GR-MD-02,

and we cannot be certain that these product candidates will receive regulatory approval or be successfully commercialized.

We currently have no

products for sale, and we cannot guarantee that we will ever have any drug products approved for sale.

We and our product candidates are subject to extensive regulation by the FDA and comparable regulatory authorities in other countries governing,

among other things, research, testing, clinical trials, manufacturing, labeling, promotion, selling, adverse event reporting and recordkeeping.

We are not permitted to market any of our product candidates in or outside the United States until we

receive approval of a new drug application for a product candidate from the FDA or the equivalent approval from a foreign regulatory authority.

We are dependent on the success of our lead product candidate, belapectin, and we cannot be certain that these product candidates will receive regulatory approval or be successfully commercialized.

We currently have no products for sale, and we cannot guarantee that we will ever have any drug products approved for sale.

We and our product candidates are subject to extensive regulation by the FDA and comparable regulatory authorities in other countries governing, among other things, research, testing, clinical trials, manufacturing, labeling, promotion, selling, adverse event reporting and recordkeeping.

We are not permitted to market any of our product candidates in or outside the United States until we receive approval of a new drug application for a product candidate from the FDA or the equivalent approval from a foreign regulatory authority.

Obtaining FDA approval is a lengthy, expensive and uncertain process.

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studies and clinical trials to demonstrate the safety and efficacy of our product candidates in humans.

To obtain FDA approval, we will need to conduct

one or more Phase 3 clinical trial for GR-MD-02;

To obtain FDA approval, we will need to conduct one or more Phase 3 clinical trial for belapectin;

however, we cannot assure you that we will be able to finance Phase 3 trials.

Additionally, we cannot assure you that

future our trials will yield successful results, that they will lead to the generation of revenue, or that we will obtain regulatory approval in other countries.

Pre-clinical studies and clinical trials are expensive, time-consuming and ultimately may not be successful.

results of pre-clinical and initial clinical testing of these products may not necessarily indicate the results that will

be obtained from later or more extensive testing.

Additionally, we cannot assure you that future our trials will yield successful results, that they will lead to the generation of revenue, or that we will obtain regulatory approval in other countries.

studies and clinical trials are expensive, time-consuming and ultimately may not be successful.

The results of pre-clinical

and initial clinical testing of these products may not necessarily indicate the results that will be obtained from later or more extensive testing.

Also, it is possible to suffer significant setbacks in advanced clinical trials, even after obtaining promising results in earlier trials.

example, although there was positive data from our NASH-CX Phase 2 trial for GR-MD-02, which we believe will allow us to conduct

a Phase 3 trial, it did not meet its primary endpoint.

Similarly, our Phase 2a pilot trial NASH-FX for patients with advanced fibrosis, which explored three non-invasive

For example, although there was positive data from our NASH-CX

Phase 2 trial for belapectin it did not meet its primary endpoint.

Similarly, our Phase 2a pilot trial NASH-FX

for patients with advanced fibrosis, which explored three non-invasive

imaging technologies, did not meet its primary endpoint.

We may engage others to conduct our clinical trials, including clinical research organizations and, possibly, government-sponsored agencies.

Additional clinical trials may not start or be

completed as we forecast and may not achieve the desired results.

The time required to obtain FDA and other approvals is unpredictable but often can take years following the commencement of clinical trials, depending upon the complexity of the drug

Additional clinical trials may not start or be completed as we forecast and may not achieve the desired results.

The time required to obtain FDA and other approvals is unpredictable but often can take years following the commencement of clinical trials, depending upon the complexity of the drug candidate.

Difficulty and delays in enrolling patients and registering sites for conducting clinical trials may prevent or delay product development and strain our limited financial resources.

Other life sciences companies also conducting clinical trials in patients with the disease indications that our product candidates target.

As a result, we must compete with them for clinical sites, physicians and the limited number of patients who fulfill the stringent requirements for participation in clinical trials.

Also, due to the confidential nature of clinical trials, we do not know how many of the eligible patients may be enrolled in competing studies and who are consequently not available to us for our clinical trials.

In addition, our clinical trials have been affected by and may continue to be affected by the COVID-19

Clinical site initiation and patient enrollment as well as availability of certain required lab kits for our non-COVID-19

product candidates have been and may continue to be delayed due to prioritization of hospital resources toward the COVID-19

Some patients have not been and others may not want or be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services.

Similarly, any inability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19,

may adversely impact our clinical trial operations.

Patient enrollment depends on many factors, including the size of the patient population, the nature of the trial protocol, the proximity of patients to clinical sites, the eligibility criteria for the study and potential reduced enrollment due to the COVID-19

The delay or inability to meet planned patient enrollment may result in increased costs and delays or termination of the trial, which could have a harmful effect on our ability to develop products

Even if we receive regulatory approval, we may be unable to commercialize our product candidates.

Even if GR-MD-02 and other future product candidates achieve positive results

in clinical trials, we may be unable to commercialize them.

The availability of government and third-party payer reimbursement, and pricing, especially compared to competitor products, could affect our ability to commercialize our product

Even if belapectin and other future product candidates achieve positive results in clinical trials, we may be unable to commercialize them.

The availability of government and third-party payer reimbursement, and pricing, especially compared to competitor products, could affect our ability to commercialize our product candidates.

Our general inability to obtain necessary regulatory approvals and, if obtained, to commercialize our products would substantially impair our viability.

There are risks associated with our reliance on third parties to design trial protocols, arrange for and monitor the clinical trials, and collect and

analyze data.

As we develop products eligible for clinical trials, we will contract with independent parties to assist us in the design of the

trial protocols, arrange for and monitor the clinical trials, collect data and analyze data.

In addition, certain clinical trials for our products may be conducted by government-sponsored agencies and will be dependent on governmental participation

Additionally, GR-MD-02 is being studied by Providence Portland Medical Center in Investigator-sponsored INDs to conduct a Phase 1B studies to determine if GR-MD-02 enhances the probability of melanoma response with ipilimumab and pembrolizumab by inducing proliferation, activation and memory function of CD8+ T cells in human

This study represents a novel approach for patients with metastatic melanoma.

As with our Phase 2 trial, to undertake Phase 3 trials for GR-MD-02, we have

contracted with a third party, Covance, for assistance with the design and conduct of the trial.

We cannot be certain that the terms of any such agreement will be favorable to the company.

There are risks associated with our reliance on third parties to design trial protocols, arrange for and monitor the clinical trials, and collect and analyze data.

As we develop products eligible for clinical trials, we will contract with independent parties to assist us in the design of the trial protocols, arrange for and monitor the clinical trials, provide lab kits, collect data and analyze data and samples.

In addition, certain clinical trials for our products may be conducted by government-sponsored agencies and will be dependent on governmental participation and funding.

We have contracted with a third party, Covance, for assistance with the design and conduct of our NAVIGATE trial.

Our dependence on independent parties and clinical sites involves risks including reduced control over the timing and other aspects of our clinical trials.

There are risks associated with our reliance on third parties for manufacturing, marketing, sales, managed care and distribution infrastructure and

We do not have, and do not now intend to develop, facilities for the manufacture of any of our products for clinical or commercial

There are risks associated with our reliance on third parties for manufacturing belapectin.

We do not have, and do not now intend to develop, facilities for the manufacture of any of our products, including belapectin, for clinical or commercial production.

At this time, we are not a party to any long-term agreement with any of our suppliers, and accordingly, we have our products manufactured on a purchase-order basis from one of two primary suppliers.

We are developing relationships with

manufacturers and will enter into collaborative arrangements with licensees or have others manufacture our products on a contract basis.

We expect to depend on such collaborators to supply us with products manufactured in compliance with standards

imposed by the FDA and foreign regulators.

We have limited experience in marketing, sales or distribution, and we do not intend to develop a sales and

marketing infrastructure to commercialize our pharmaceutical products.

If we develop commercial products, we will need to rely on licensees, collaborators, joint venture partners or independent distributors to market and sell those products.

we expect that we will be required to enter into agreements with commercial partners to engage in sales, marketing and distribution efforts around our products in development.

We may be unable to establish or maintain third-party relationships on a

commercially reasonable basis, if at all.

In addition, these

third parties may have similar or more established relationships with our competitors.

If we do not enter into relationships with third parties for the sales and marketing of our proposed

products, we will need to develop our own sales and marketing capabilities.

Even if engaged, these distributors may:

fail to satisfy financial or contractual obligations to us;

fail to adequately market our products;

cease operations with little or no notice to us;

offer, design, manufacture or promote competing formulations or products.

If we fail to develop sales, managed care, marketing and distribution channels, we would experience delays in generating sales and incur increased costs,

which would harm our financial results.

We are exposed to product liability, pre-clinical and clinical

liability risks, which could place a financial burden upon us, should we be sued, because we do not currently have product liability insurance beyond our general insurance coverage.

Our business exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing and marketing of

pharmaceutical formulations and products;

We are developing relationships with manufacturers and will enter into collaborative arrangements with licensees or have others manufacture our products on a contract basis.

We expect to depend on such collaborators to supply us with products manufactured in compliance with standards imposed by the FDA and foreign regulators.

We are exposed to pre-clinical

and clinical liability risks which could place a financial burden upon us, should we be sued, because we do not currently have product liability insurance beyond our general insurance coverage.

Our business exposes us to potential pre-clinical,

clinical liability and other liability risks that are inherent in the testing pharmaceutical formulations and products;

accordingly, claims may be asserted against us.

In addition, the use in our clinical trials of pharmaceutical formulations and products that our potential collaborators may develop and the subsequent sale of

such formulations or products by us or our potential collaborators may cause us to assume a portion of or all of the product liability risks.

A successful liability claim or series of claims brought against us could have a material adverse effect on

our business, financial condition and results of operations.

In addition, the use in our clinical trials of pharmaceutical formulations and products that our potential collaborators may develop and the subsequent sale of such formulations or products by us or our potential collaborators may cause us to assume a portion of or all of the product liability risks.

A successful liability claim or series of claims brought against us could have a material adverse effect on our business, financial condition and results of operations.

Because we do not currently have any FDA-approved

products or formulations, we do not currently have any product liability insurance covering commercialized products.

We may not be able to obtain or maintain adequate product liability insurance on acceptable terms, if at all, or such insurance may

not provide adequate coverage against our potential liabilities.

Furthermore, our current and potential partners with whom we have collaborative agreements or our future licensees may not be willing to indemnify us against these types of liabilities

and may not, themselves, be sufficiently insured or have sufficient liquidity to satisfy any product liability claims.

Claims or losses in excess of any product liability insurance coverage that may be obtained by us could have a material adverse

effect on our business, financial condition and results of operations.

We face intense competition in the biotechnology and pharmaceutical

Our current and potential partners with whom we have collaborative agreements or our future licensees may not be willing to indemnify us against these types of liabilities and may not, themselves, be sufficiently insured or have sufficient liquidity to satisfy any product liability claims.

Claims or losses in excess of any insurance coverage that may be obtained by us could have a material adverse effect on our business, financial condition and results of operations.

We face intense competition in the biotechnology and pharmaceutical industries.

The biotechnology and pharmaceutical industries are intensely competitive.

We face direct competition from U.S.

and foreign companies

focusing on pharmaceutical products, which are rapidly evolving.

and foreign companies focusing on pharmaceutical products, which are rapidly evolving.

Our competitors include major multinational pharmaceutical and chemical companies, specialized biotechnology firms and universities and other research institutions.

Many of these

competitors possess greater financial and other resources, larger research and development staffs and more effective marketing and manufacturing organizations than we possess.

In addition, academic and government institutions are increasingly likely

to enter into exclusive licensing agreements with commercial enterprises, including our competitors, to market commercial products based on technology developed at such institutions.

Our competitors may succeed in developing or licensing

technologies and products that are more effective or succeed in obtaining FDA or other regulatory approvals for product candidates before we do.

Acquisitions of, or investments in, competing pharmaceutical or biotechnology companies by large

corporations could increase such competitors financial, marketing, manufacturing and other resources.

The market for our proposed products is rapidly changing and competitive, and new drugs and new

treatments which may be developed by others could impair our ability to maintain and grow our business and remain competitive.

The pharmaceutical

and biotechnology industries are subject to rapid and substantial technological change.

Developments by others may render our proposed products noncompetitive or obsolete, or we may be unable to keep pace with technological developments or other

market factors.

Many of these competitors possess greater financial and other resources, larger research and development staffs and more effective marketing and manufacturing organizations than we possess.

In addition, academic and government institutions are increasingly likely to enter into exclusive licensing agreements with commercial enterprises, including our competitors, to market commercial products based on technology developed at such institutions.

Our competitors may succeed in developing or licensing technologies and products that are more effective or succeed in obtaining FDA or other regulatory approvals for product candidates before we do.

Acquisitions of, or investments in, competing pharmaceutical or biotechnology companies by large corporations could increase such competitors’ financial, marketing, manufacturing and other resources.

The market for our proposed products is rapidly changing and competitive, and new drugs and new treatments that may be developed by others could impair our ability to maintain and grow our business and remain competitive.

The pharmaceutical and biotechnology industries are subject to rapid and substantial technological change.

Developments by others may render our proposed products noncompetitive or obsolete, or we may be unable to keep pace with technological developments or other market factors.

Technological competition from pharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the field is intense and is expected to increase.

As a pre-revenue company engaged in the development of drug technologies, our resources are limited and we may

experience technical challenges inherent in such technologies.

Competitors have developed or are in the process of developing technologies that are, or in the future may be, the basis for competition.

Some of these technologies may have an entirely

different approach or means of accomplishing similar therapeutic effects compared to our proposed products.

Our competitors may develop drugs that are safer, more effective and less costly than our proposed products and, therefore, present a serious

competitive threat to us.

The potential widespread acceptance of therapies that are alternatives to ours may limit market acceptance of our proposed

products, even if commercialized.

Our resources are limited and we may experience technical challenges inherent in such technologies.

Our competitors may develop drugs that are safer, more effective and less costly than our proposed products and, therefore, present a serious competitive threat to us.

The potential widespread acceptance of therapies that are alternatives to ours may limit market acceptance of our proposed products, even if commercialized.

Some of our targeted diseases and conditions may also be treated by other medications.

These treatments may be widely accepted in medical communities and have a longer history of use.

The established use of these

competitive drugs may limit the potential for our technologies, formulations and products to receive widespread acceptance even if commercialized.

The established use of these competitive drugs may limit the potential for our technologies, formulations and products to receive widespread acceptance even if commercialized.

Our lack of operating experience may cause us difficulty in managing our growth.

We have limited experience in manufacturing or procuring products in commercial quantities, conducting other later-stage phases of the regulatory approval

process, selling pharmaceutical products, and negotiating, establishing and maintaining strategic relationships.

Although we may engage consultants to assist us, any additional growth may require us to expand our management, operational and

financial systems and controls.

We have limited experience in manufacturing or procuring products in commercial quantities, conducting other later-stage phases of the regulatory approval process, selling pharmaceutical products, and negotiating, establishing and maintaining strategic relationships.

Although we may engage consultants to assist us, any additional growth may require us to expand our management, operational and financial systems and controls.

If we are unable to do so, our business and financial condition would be materially harmed.

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We depend on key individuals to develop our products and core technologies and pursue collaborative relationships.

We are highly dependent on our current base of employees and external hepatology consultants.

These individuals, among other things, design and lead our pre-clinical and clinical studies, as well as our U.S.

We are highly dependent on our current base of a few employees and external hepatology consultants.

These individuals, among other things, design and lead our pre-clinical

and clinical studies, as well as our U.S.

and European regulatory processes.

The loss of any personnel or failure to attract or retain other key personnel and consultants could prevent us from

developing our products and core technologies and pursuing collaborative relationships.

We may fail to comply with our reporting and other

requirements under federal securities laws.

With little or no redundancy in our personnel, the loss of any personnel or failure to attract or retain other key personnel and consultants could result in a loss of experience and accumulated knowledge and prevent us from developing our products and core technologies and pursuing collaborative relationships.

We may fail to comply with our reporting and other requirements under federal securities laws.

As a publicly traded company, we are subject to the reporting requirements of the Exchange Act.

Exchange Act requires that we file annual, quarterly and current reports.

Our failure to prepare and disclose this information in a timely manner could subject us to penalties under federal securities laws, expose us to lawsuits and restrict our

ability to access financing.

We may be required to implement additional and expensive finance and accounting systems, procedures and controls as we grow our business and organization to satisfy new reporting requirements, which will increase our

costs and require additional management resources.

Our long-term success is dependent not only upon the success of our trials but also upon us

being able to capitalize upon potential positive results of our trials, which is not assured.

To conduct Phase 3 clinical trials or other clinical

trials we will need sufficient cash resources to conduct those undertakings.

We will also need to obtain sufficient dosages of GR-MD-02 for such trials.

Manufacturing of

GR-MD-02 is performed by third parties on a contract basis and production is ongoing to generate what we believe

are sufficient quantities of GR-MD-02 for planned Phase 3 clinical trials.

Manufacturing could become delayed due to circumstances beyond our control which could delay

any planned Phase 3 clinical trials.

Further because of limited resources, we have curtailed most of our expenditures in research focused on the development of an oral galectin inhibitor to replace our current drug candidate that is delivered via

We have previously been a defendant in a shareholder derivative action, and any possible future such lawsuits may adversely affect

our business, financial condition, results of operations and cash flows.

We and certain of our officers and directors have previously been

defendants in a state court shareholder derivative action that concluded in our favor.

The Exchange Act requires that we file annual, quarterly and current reports.

Our failure to prepare and disclose this information in a timely manner could subject us to penalties under federal securities laws, expose us to lawsuits and restrict our ability to access financing.

Our long-term success is dependent not only upon the success of our trials but also upon us being able to capitalize upon potential positive results of our trials, which is not assured.

To conduct Phase 3 clinical trials or other clinical trials we will need sufficient cash resources to conduct those undertakings.

We will also need to obtain sufficient dosages of belapectin for such trials.

Manufacturing of belapectin is performed by third parties on a contract basis and production is ongoing to generate what we believe are sufficient quantities of belapectin for our NAVIGATE or other clinical trials.

Manufacturing could become delayed due to circumstances beyond our control which could delay any clinical trials.

We have previously been a defendant in a shareholder derivative action, and any possible future such lawsuits may adversely affect our business, financial condition, results of operations and cash flows.

We and certain of our officers and directors have previously been defendants in a state court shareholder derivative action that concluded in our favor.

In addition, there is the potential for other future shareholder litigation and for governmental investigations and/or enforcement actions.

Similar lawsuits in

the future may divert our attention from our ordinary business operations, and we may incur significant expenses associated with their defense (including, without limitation, substantial attorneys fees and other fees of professional advisors

and potential obligations to indemnify current and former officers and directors who are or may become parties to such actions).

If similar lawsuits do arise in the future, we may be required to pay material damages and fines, consent to injunctions

on future conduct and/or suffer other penalties, remedies or sanctions.

Accordingly, the ultimate resolution of these matters could have a material adverse effect on our business, results of operations, financial condition, liquidity and ability to

meet our debt obligations and, consequently, could negatively impact the trading price of our common stock.

Any existing or future shareholder lawsuits and any future governmental investigations and/or enforcement actions could adversely impact our

reputation, our relationships with our customers and our ability to generate revenue.

Similar lawsuits in the future may divert our attention from our ordinary business operations, and we may incur significant expenses associated with their defense (including, without limitation, substantial attorneys’ fees and other fees of professional advisors and potential obligations to indemnify current and former officers and directors who are or may become parties to such actions).

If similar lawsuits do arise in the future, we may be required to pay material damages and fines, consent to injunctions on future conduct and/or suffer other penalties, remedies or sanctions.

Accordingly, the ultimate resolution of these matters could have a material adverse effect on our business, results of operations, financial condition, liquidity and ability to meet any debt obligations and, consequently, could negatively impact the trading price of our common stock.

Any existing or future shareholder lawsuits and any future governmental investigations and/or enforcement actions could adversely impact our reputation, our relationships with our customers and our ability to generate revenue.

Risks Related to the Regulation of our Products

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We are required to obtain approval (i) from the FDA in order to sell our products in the U.S.

and (ii) from foreign regulatory authorities in order

to sell our products in other countries.

and (ii) from foreign regulatory authorities in order to sell our products in other countries.

The FDA’s review and approval process is lengthy, expensive and uncertain.

Extensive pre-clinical and clinical data and supporting information must be submitted to

the FDA for each indication for each product candidate in order to secure FDA approval.

Before receiving FDA clearance to market our proposed products, we will have to demonstrate that our products are safe on the patient population and effective

for the diseases that are to be treated.

Extensive pre-clinical

and clinical data and supporting information must be submitted to the FDA for each indication for each product candidate in order to secure FDA approval.

Before receiving FDA clearance to market our proposed products, we will have to demonstrate that our products are safe on the patient population and effective for the diseases that are to be treated.

Clinical trials, manufacturing and marketing of drugs are subject to the rigorous testing and approval process of the FDA and equivalent foreign regulatory authorities.

FDA may change, at any time, its

requirements for approval of new drugs based on information and data received from others and ourselves potentially resulting in product approval delays or non-approvals.

The Federal Food, Drug and Cosmetic

Act and other federal, state and foreign statutes and regulations govern and influence the testing, manufacture, labeling, advertising, distribution and promotion of drugs and medical devices.

As a result, regulatory approvals can take several years

to acquire and may further require the expenditure of substantial financial, managerial and other resources.

The FDA could reject an application or, in the alternative, require us to conduct additional clinical or other studies as part of the

regulatory review process.

FDA may change, at any time, its requirements for approval of new drugs based on information and data received from others and ourselves potentially resulting in product approval delays or non-approvals.

The Federal Food, Drug and Cosmetic Act and other federal, state and foreign statutes and regulations govern and influence the testing, manufacture, labeling, advertising, distribution and promotion of drugs and medical devices.

As a result, regulatory approvals can take several years to acquire and may further require the expenditure of substantial financial, managerial and other resources.

The FDA could reject an application or, in the alternative, require us to conduct additional clinical or other studies as part of the regulatory review process.

Delays in obtaining or failure to obtain FDA approvals would delay or prevent the commercialization of our product candidates, which would prevent, defer or decrease our receipt of revenues.

In addition, should we receive

initial regulatory approval, our product candidates will be subject to extensive and rigorous ongoing domestic and foreign government regulation.

In addition, should we receive initial regulatory approval, our product candidates will be subject to extensive and rigorous ongoing domestic and foreign government regulation.

Even if we obtain regulatory approvals, our marketed drugs will be subject to ongoing regulatory review.

If we fail to comply with ongoing regulatory

requirements, we could lose our approvals to market drugs, in which case our business would be materially adversely affected.

Following regulatory

approval in the United States of any drugs we may develop, we will remain subject to continuing regulatory review, including the review of adverse drug experiences and clinical results that are

reported after our drug products are made available to patients.

If we fail to comply with ongoing regulatory requirements, we could lose our approvals to market drugs, in which case our business would be materially adversely affected.

Following regulatory approval in the United States of any drugs we may develop, we will remain subject to continuing regulatory review, including the review of adverse drug experiences and clinical results that are reported after our drug products are made available to patients.

This would include results from any post marketing tests or vigilance required as a condition of approval.

The manufacturer and

manufacturing facilities we use to make any of our drug products will also be subject to periodic review and inspection by the FDA.

The discovery of any new or previously unknown problems with the product, manufacturer or facility may result in

restrictions on the drug, manufacturer or facility, including withdrawal of the drug from the market.

We would continue to be subject to the FDA requirements governing the labeling, packaging, storage, advertising, promotion, recordkeeping, and

submission of safety and other post-market information for all of our product candidates, even those that the FDA had approved.

If we fail to comply with applicable continuing regulatory requirements, we may be subject to fines, suspension or

withdrawal of regulatory approval, product recalls and seizures, operating restrictions and other adverse consequences.

The drug development

process to obtain FDA approval is very costly and time consuming, and if we cannot complete our clinical trials in a cost-effective manner, our results of operations may be adversely affected.

Costs and timing of clinical trials may vary significantly over the life of a project owing to the following

non-exclusive reasons:

The manufacturer and manufacturing facilities we use to make any of our drug products will also be subject to periodic review and inspection by the FDA.

The discovery of any new or previously unknown problems with the product, manufacturer or facility may result in restrictions on the drug, manufacturer or facility, including withdrawal of the drug from the market.

We would continue to be subject to the FDA requirements governing the labeling, packaging, storage, advertising, promotion, recordkeeping, and submission of safety and other post-market information for all of our product candidates, even those that the FDA had approved.

If we fail to comply with applicable continuing regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approval, product recalls and seizures, operating restrictions and other adverse consequences.

The drug development process to obtain FDA approval is very costly and time consuming, and if we cannot complete our clinical trials in a cost-effective manner, our results of operations may be adversely affected.

Costs and timing of clinical trials may vary significantly over the life of a project owing to the following non-exclusive

the duration of the clinical trials;

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the number of doses that patients receive;

the drop-out or discontinuation rates of patients;

or discontinuation rates of patients;

per patient trial costs;

third party contractors failing to comply with regulatory requirements or meet their contractual obligations to

us in a timely manner;

our drug product candidates having different chemical and pharmacological properties in humans than in lab

third party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner;

our drug product candidates having different chemical and pharmacological properties in humans than in lab testing;

the need to suspend or terminate our clinical trials;

insufficient or inadequate supply or quality of drug product candidates or other necessary materials to conduct

potential additional safety monitoring, or other conditions required by FDA or comparable foreign regulatory

authorities regarding the scope or design of our clinical trials, or other studies requested by regulatory agencies;

insufficient or inadequate supply or quality of drug product candidates or other necessary materials to conduct our trials;

potential additional safety monitoring, or other conditions required by FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials, or other studies requested by regulatory agencies;

problems engaging IRBs to oversee trials or in obtaining and maintaining IRB approval of studies;

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the costs involved in enforcing or defending patent claims or other intellectual property rights.

Each of the above factors and other unanticipated factors beyond our control could prevent us from gaining approval for our drugs in a

cost-effective and timely manner, which could have a material adverse impact on our business.

If users of our proposed products are unable to obtain adequate reimbursement from third-party payers,

market acceptance of our proposed products may be limited, and we may not achieve revenues or profits.

The continuing efforts of governments,

insurance companies, health maintenance organizations and other payers of healthcare costs to contain or reduce costs of health care may affect our future revenues and profitability as well as the future revenues and profitability of our potential

customers, suppliers and collaborative partners in addition to the availability of capital.

Our ability to commercialize our proposed products will depend in large part on the extent to which appropriate reimbursement levels for the cost of our

proposed formulations, products and related treatments are obtained by the health care providers of these products and treatments.

It is possible that the adoption new health care reform legislation or legislation to replace the current health care

reimbursement system could harm our business, financial condition and results of operations.

Data obtained from clinical trials are not necessarily

predictive of future results, may be negative or inconclusive, and are susceptible to varying interpretations, which could delay, limit or prevent regulatory clearances.

Data already obtained, or in the future obtained, from pre-clinical studies and clinical trials do not necessarily

predict the results that will be obtained from later pre-clinical studies and clinical trials.

Moreover, pre-clinical and clinical data may be negative or inconclusive.

Each of the above factors and other unanticipated factors beyond our control could prevent us from gaining approval for our drugs in a cost-effective and timely manner, which could have a material adverse impact on our business.

Data obtained from clinical trials are not necessarily predictive of future results, may be negative or inconclusive, and are susceptible to varying interpretations, which could delay, limit or prevent regulatory clearances.

Data already obtained, or in the future obtained, from pre-clinical

studies and clinical trials do not necessarily predict the results that will be obtained from later pre-clinical

studies and clinical trials.

Moreover, pre-clinical

and clinical data may be negative or inconclusive.

In addition, data is susceptible to varying interpretations.

Negative or inconclusive data, or data interpreted in various ways, could delay, limit or prevent regulatory approval.

A number of companies in the pharmaceutical industry have suffered

significant setbacks in advanced clinical trials, even after they obtained promising results in earlier trials.

Despite the results reported in some of our earlier clinical trials for

GR-MD-02, our clinical trials may not demonstrate sufficient levels of safety and efficacy necessary to obtain the requisite regulatory approvals for our drugs, and

thus, our proposed drugs may not be approved for marketing.

A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after they obtained promising results in earlier trials.

Despite the results reported in some of our earlier clinical trials for belapectin, our clinical trials may not demonstrate sufficient levels of safety and efficacy necessary to obtain the requisite regulatory approvals for our drugs, and thus, our proposed drugs may not be approved for marketing.

If later-stage clinical trials do not produce favorable results, our ability to achieve regulatory approval for any of our product candidates may be adversely impacted.

The failure to

adequately demonstrate the safety and effectiveness of a proposed formulation or product under development could delay or prevent regulatory clearance of the potential drug.

The resulting delays in commercialization could materially harm our

Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval,

limit the commercial profile of an approved label, or result in significant negative consequences following any marketing approval.

side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other

comparable foreign regulatory authority.

The failure to adequately demonstrate the safety and effectiveness of a proposed formulation or product under development could delay or prevent regulatory clearance of the potential drug.

The resulting delays in commercialization could materially harm our business.

Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any marketing approval.

Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authority.

Although we are not currently aware of any undesirable side effects caused by our product candidates, it is possible that they may be identified in the clinical trial process.

As a result of undesirable side effects or safety or toxicity issues that we may experience in our clinical trials, we may not receive approval to market any

product candidates, which could prevent us from ever generating revenues or achieving profitability.

As a result of undesirable side effects or safety or toxicity issues that we may experience in our clinical trials, we may not receive approval to market any product candidates, which could prevent us from ever generating revenues or achieving profitability.

Results of our trials could reveal an unacceptably high severity and prevalence of side effects.

In such an event, our trials could be suspended or

terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development or deny approval of our product candidates for any or all targeted indications.

These side effects could affect patient recruitment or

the ability of enrolled subjects to complete the trial or result in potential product liability claims.

Additionally, if any of our product candidates

receives marketing approval, and we or others later identify undesirable side effects caused by such product, a number of potentially significant negative consequences could result, including:

In such an event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development or deny approval of our product candidates for any or all targeted indications.

These side effects could affect patient recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims.

Additionally, if any of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such product, a number of potentially significant negative consequences could result, including:

we may be forced to suspend marketing of such product;

regulatory authorities may withdraw their approvals of such product;

regulatory authorities may require additional warnings on the label that could diminish the usage or otherwise

limit the commercial success of such products;

regulatory authorities may require additional warnings on the label that could diminish the usage or otherwise limit the commercial success of such products;

we may be required to conduct post-market studies;

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Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved.

We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our

A pharmaceutical product cannot be marketed in the U.S.

or other countries until it has completed rigorous and extensive regulatory

review processes, including approval of a brand name.

Any brand names we intend to use for our product candidates will require approval from the FDA regardless of whether we have secured a formal trademark registration from the U.S.

Trademark Office, or the PTO.

The FDA typically conducts a review of proposed product brand names, including an evaluation of potential for confusion with other product names.

The FDA may also object to a product brand name if it believes the name

inappropriately implies medical claims.

If the FDA objects to any of our proposed product brand names, we may be required to adopt an alternative brand name for our product candidates.

If we adopt an alternative brand name, we would lose the benefit

of our existing trademark applications for such product candidate and may be required to expend significant additional resources in an effort to identify a suitable product brand name that would qualify under applicable trademark laws, not infringe

the existing rights of third parties and be acceptable to the FDA.

We may be unable to build a successful brand identity for a new trademark in a timely manner or at all, which would limit our ability to commercialize our product candidates.

Failure to obtain regulatory approval in international jurisdictions would prevent our product candidates from being marketed abroad.

In order to market and sell our products in the European Union and many other jurisdictions, we must obtain separate marketing approvals and comply with

numerous and varying regulatory requirements.

In order to market and sell our products in the European Union and many other jurisdictions, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.

The approval procedure varies among countries and can involve additional testing.

The time required to obtain approval may differ substantially from that required to obtain FDA approval.

The regulatory

approval process outside the United States generally includes all of the risks associated with obtaining FDA approval.

In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the

product can be approved for sale in that country.

The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval.

In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved for sale in that country.

We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all.

Approval by the FDA does not ensure approval by regulatory authorities in other

countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.

We may not be able to file for marketing approvals

and may not receive necessary approvals to commercialize our products in any market.

If we are unable to obtain approval of any of our product candidates by regulatory authorities in the European Union or other countries, the commercial prospects of

that product candidate may be significantly diminished, and our business prospects could decline.

Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.

We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our products in any market.

If we are unable to obtain approval of any of our product candidates by regulatory authorities in the European Union or other countries, the commercial prospects of that product candidate may be significantly diminished, and our business prospects could decline.

Risks Related to Our Intellectual Property

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Development and protection of our intellectual property are critical to our business.

All of our intellectual property, patented or otherwise, has been

invented and/or developed by employees or former employees of the

All of our intellectual property, patented or otherwise, has been invented and/or developed by employees or former employees of the Company.

Our success depends, in part, on our ability to obtain patent protection for our products or processes in the U.S.

and other countries, protect trade secrets and prevent others from

infringing on our proprietary rights.

We will only be able to protect our product candidates from unauthorized making, using, selling, offering to sell or importation by third parties to the extent that we have rights under valid and enforceable

patents or trade secrets that cover these activities.

and other countries, protect trade secrets and prevent others from infringing on our proprietary rights.

If we do not adequately protect our intellectual property, competitors may be able to practice our technologies.

The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important

legal principles remain unresolved.

The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.

No consistent policy regarding the breadth of claims allowed in biotechnology patents has emerged to date in the United States.

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Changes in either the patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property.

Accordingly, we cannot predict the breadth of claims that may be allowed in our

pending patent applications or enforced in our issued patents or in third-party patents.

The degree of future protection for our proprietary rights is

uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.

others may be able to make compounds that are competitive with our product candidates but are not covered by the

claims of our patents;

Accordingly, we cannot predict the breadth of claims that may be allowed in our pending patent applications or enforced in our issued patents or in third-party patents.

The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.

others may be able to make compounds that are competitive with our product candidates but are not covered by the claims of our patents;

we might not have been the first to make the inventions covered by our pending patent applications;

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We also may rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable.

However, trade

secrets are difficult to protect.

proprietary information to enter into confidentiality agreements, these agreements may not be honored.

Enforcing a claim that a third party illegally obtained, and is using, our trade secrets is expensive and time consuming, and the outcome is

unpredictable.

However, trade secrets are difficult to protect.

Although we require our scientific and technical employees and consultants to enter into broad assignment of inventions agreements, and all of our employees, consultants and corporate partners with access to proprietary information to enter into confidentiality agreements, these agreements may not be honored.

Enforcing a claim that a third party illegally obtained, and is using, our trade secrets is expensive and time consuming, and the outcome is unpredictable.

In addition, courts outside the United States are sometimes less willing to protect trade secrets.

Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.

We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may

be unable to protect our rights to, or use of, our technology.

Some or all of our patent applications may not issue as patents, or the claims of

any issued patents may not afford meaningful protection for our technologies or products.

We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, and we may be unable to protect our rights to, or use of, our technology.

Some or all of our patent applications may not issue as patents, or the claims of any issued patents may not afford meaningful protection for our technologies or products.

In addition, patents issued to us or our licensors, if any, may be challenged and subsequently narrowed, invalidated or circumvented.

Patent litigation is

widespread in the biotechnology industry and could harm our business.

Patent litigation is widespread in the biotechnology industry and could harm our business.

Litigation might be necessary to protect our patent position or to determine the scope and validity of third-party proprietary rights.

If we choose to go to court to stop someone else from using the inventions claimed in our patents, that individual or company would have the right to ask the

court to rule that such patents are invalid and/or should not be enforced against that third party.

If we choose to go to court to stop someone else from using the inventions claimed in our patents, that individual or company would have the right to ask the court to rule that such patents are invalid and/or should not be enforced against that third party.

These lawsuits are expensive, and we may not have the required resources to pursue such litigation or to protect our patent rights.

there is a risk that the court will decide that these patents are not valid and that we do not have the right to stop the other party from using the inventions.

There is also the risk that, even if the validity of these patents is upheld, the court

will refuse to stop the other party on the ground that such other partys activities do not infringe our rights in these patents.

Furthermore, a third party may claim that we are using inventions covered by the third partys patent

rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates.

These lawsuits are costly and could affect our results of operations and divert the attention of

managerial and technical personnel.

In addition, there is a risk that the court will decide that these patents are not valid and that we do not have the right to stop the other party from using the inventions.

There is also the risk that, even if the validity of these patents is upheld, the court will refuse to stop the other party on the ground that such other party’s activities do not infringe our rights in these patents.

Furthermore, a third party may claim that we are using inventions covered by the third party’s patent rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates.

These lawsuits are costly and could affect our results of operations and divert the attention of managerial and technical personnel.

There is a risk that a court would decide that we are infringing the third party’s patents and would order us to stop the activities covered by the patents.

In addition, there is a risk that a court will

order us to pay the other party treble damages for having violated the other partys patents.

The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents

cover various types of products or methods of use.

In addition, there is a risk that a court will order us to pay the other party treble damages for having violated the other party’s patents.

The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use.

The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.

If we are sued for patent infringement, we would need to demonstrate that our

products or methods of use either do not infringe the claims of the relevant patent and/or that the patent claims are invalid, and we may not be able to do this.

Proving invalidity in the U.S., in particular, is difficult since it requires a showing

of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.

Because some patent applications in the United States

may be maintained in secrecy until the patents are issued, patent applications in the United States and many foreign jurisdictions are typically not published until eighteen months after filing, and publications in the scientific literature often

lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our issued patents or our pending applications or that we were the first to invent the technology.

Our competitors may have

filed, and may in the future file, patent applications covering technology similar to ours.

Any such patent application may have priority over our patent applications and could further require us to obtain rights to issued patents covering such

technologies.

If another party has filed a United States patent application on inventions similar to ours, we may have to participate in an interference or other proceeding in the PTO or a court to determine priority of invention in the United

If we are sued for patent infringement, we would need to demonstrate that our products or methods of use either do not infringe the claims of the relevant patent and/or that the patent claims are invalid, and we may not be able to do this.

Proving invalidity in the U.S., in particular, is difficult since it requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.

Because some patent applications in the United States may be maintained in secrecy until the patents are issued, patent applications in the United States and many foreign jurisdictions are typically not published until eighteen months after filing, and publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our issued patents or our pending applications or that we were the first to invent the technology.

Our competitors may have filed, and may in the future file, patent applications covering technology similar to ours.

Any such patent application may have priority over our patent applications and could further require us to obtain rights to issued patents covering such technologies.

The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our United States patent position with respect to such inventions.

Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater

Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources.

In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations.

Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other requirements

imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during

the patent process.

Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance

with these requirements.

The PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process.

There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

In such an event, competitors

might be able to enter the market earlier than would otherwise have been the case.

Our failure to secure trademark registration could adversely

affect our ability to market our product candidates and our business.

Our trademark applications in the United States, when filed, and any other

jurisdictions where we may file may not be allowed for registration, and our registered trademarks may not be maintained or enforced.

During trademark registration proceedings, we may receive rejections.

Although we are given an opportunity to

respond to those rejections, we may be unable to overcome such rejections.

In addition, in the PTO 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.

In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.

Our failure to secure trademark registration could adversely affect our ability to market our product candidates and our business.

Our trademark applications in the United States, when filed, and any other jurisdictions where we may file may not be allowed for registration, and our registered trademarks may not be maintained or enforced.

During trademark registration proceedings, we may

receive rejections.

Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections.

In addition, in the PTO 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 applications and/or registrations, and our applications and/or registrations may not survive such proceedings.

Failure to secure such trademark

registrations in the United States and in foreign jurisdictions could adversely affect our ability to market our product candidates and our business.

Confidentiality agreements with employees and others may not adequately prevent disclosure of our

trade secrets and other proprietary information and may not adequately protect our intellectual property, which could impede our ability to compete.

Because we operate in the highly technical field of biotechnology and pharmaceutical development, we rely in part on trade secret protection in order to

protect our proprietary trade secrets and unpatented know-how.

However, trade secrets are difficult to protect, and we cannot be certain that others will not develop the same or similar technologies on their

Failure to secure such trademark registrations in the United States and in foreign jurisdictions could adversely affect our ability to market our product candidates and our business.

Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could impede our ability to compete.

Because we operate in the highly technical field of biotechnology and pharmaceutical development, we rely in part on trade secret protection in order to protect our proprietary trade secrets and unpatented know-how.

However, trade secrets are difficult to protect, and we cannot be certain that others will not develop the same or similar technologies on their own.

We have taken steps, including entering into confidentiality agreements with all of our employees, consultants and corporate partners to protect our trade secrets and unpatented know-how.

These agreements

generally require that the other party keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party by us during the course of the partys relationship with us.

typically obtain agreements from these parties which provide that inventions conceived by the party in the course of rendering services to us will be our exclusive property.

However, these agreements may not be honored and may not effectively assign

intellectual property rights to us.

Enforcing a claim that a party illegally obtained and is using our trade secrets or know-how is difficult, expensive and time consuming, and the outcome is unpredictable.

addition, courts outside the United States may be less willing to protect trade secrets or know-how.

These agreements generally require that the other party keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party by us during the course of the party’s relationship with us.

We also typically obtain agreements from these parties that provide that inventions conceived by the party in the course of rendering services to us will be our exclusive property.

However, these agreements may not be honored and may not effectively assign intellectual property rights to us.

Enforcing a claim that a party illegally obtained and is using our trade secrets or know-how

is difficult, expensive and time consuming, and the outcome is unpredictable.

In addition, courts outside the United States may be less willing to protect trade secrets or know-how.

The failure to obtain or maintain trade secret protection could adversely affect our competitive position.

We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

As is common in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at other biotechnology or pharmaceutical

companies, including our competitors or potential competitors.

Although no claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other

proprietary information of their former employers.

As is common in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors.

Although no claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers.

Litigation may be necessary to defend against these claims.

Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to

Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

Risks Related to Our Common Stock

The market price of our common stock may be volatile and adversely affected by several factors.

This could subject us to securities class action

litigation and our stockholders could incur substantial losses.

The market price of our common stock could fluctuate significantly in response to

various factors and events, including but not limited to:

the results of our pre-clinical studies and clinical trials, including

interim results, as well as those of our competitors;

This could subject us to securities class action litigation, and our stockholders could incur substantial losses.

The market price of our common stock could fluctuate significantly in response to various factors and events, including but not limited to:

the results of our pre-clinical

studies and clinical trials, including interim results, as well as those of our competitors;

regulatory actions with respect to our products or our competitors’ products;

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operating results below expectations;

our issuance of additional securities, including debt or equity or a combination thereof, which may be necessary

to fund our operating expenses and the cost of our clinical trials;

our issuance of additional securities, including debt or equity or a combination thereof, which may be necessary to fund our operating expenses and the cost of our clinical trials;

announcements of technological innovations or new products by us or our competitors;

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loss of any strategic relationship;

industry developments, including, without limitation, changes in healthcare policies or practices or third-party

reimbursement policies;

industry developments, including, without limitation, changes in healthcare policies or practices or third-party reimbursement policies;

regulatory or legal developments in the United States and other countries;

the level of expenses related to any of our product candidates or clinical development programs;

disputes or other developments related to proprietary rights, including patents, litigation matters, and our

ability to obtain patent protection for our technologies;

disputes or other developments related to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies;

economic and other external factors;

period-to-period fluctuations in

our financial results;

period-to-period

fluctuations in our financial results;

sales of our common stock by us, our insiders or our other stockholders;

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engagement and retention of senior management needed for our clinical trials;

In addition, the market price for securities of pharmaceutical and biotechnology companies historically has been highly volatile, and the securities markets

have from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies.

These broad market fluctuations may cause the market price of our common stock to decline

substantially.

In the past, securities class action litigation has often been brought against a company, including us, following a decline in the market

price of its securities.

novel and unforeseen market forces and trading strategies, such as the massive short squeeze rally caused by retail investors on companies such as Gamestop.

In addition, the market price for securities of pharmaceutical and biotechnology companies historically has been highly volatile, and the securities markets have from time-to-time

experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies.

These broad market fluctuations may cause the market price of our common stock to decline substantially.

In the past, securities class action litigation has often been brought against a company, including us, following a decline in the market price of its securities.

This risk is especially relevant for us because biotechnology and biopharmaceutical companies have experienced significant stock price volatility in recent years.

As described above, we have recently defended a consolidated

federal securities class action lawsuit and a consolidated shareholder derivative actions, and we may become involved in additional instances of this type of litigation in the future.

Litigation often is expensive and diverts

managements attention and resources, which could materially and adversely affect our business.

Additionally, fluctuations in the trading price or

liquidity of our common stock may materially and adversely affect, among other things, the interest of investors to purchase our common stock on the open market and, generally, our ability to raise capital.

Our board of directors has the power to designate, without stockholder approval, additional series of preferred capital, the shares of which could be

senior to our common stock and be entitled to conversion or voting rights that adversely affect the holders of our common stock.

Our articles of

incorporation authorize the issuance of capital stock including 20,000,000 authorized undesignated shares (all have been designated as of December 31, 2019), and empowers our board of directors to

prescribe, by resolution and without stockholder approval, a class or series of undesignated shares, including the number of shares in the class or series and

the voting powers, designations, rights, preferences, restrictions and the relative rights in each such class or series.

Accordingly, we may designate and issue additional shares or series of preferred stock that would rank senior to the shares of

common stock as to dividend rights or rights upon our liquidation, winding-up, or dissolution.

and our charter documents could make it more difficult for a third party to acquire us and discourage a takeover, which could depress the trading price of our common stock.

Nevada corporate law and our articles of incorporation and bylaws contain provisions that could discourage, delay, or prevent a change in control of our

Company or changes in our management that our stockholders may deem advantageous.

For example, holders of our common stock do not have cumulative voting rights in the election of directors, meaning that stockholders owning a majority of our

outstanding shares of common stock will be able to elect all of our directors.

In addition, because we have more than 200 stockholders of record, we are subject to the business combinations provisions of the Nevada Revised Statutes, or

These provisions

could prohibit or delay a merger or other takeover or change in control attempt and, accordingly, may discourage attempts to acquire our Company even though such a transaction may be in our

stockholders best interest and offer our stockholders the opportunity to sell their stock at a price above the prevailing market price.

may issue additional common stock, which might dilute the net tangible book value per share of our common stock.

Our board of directors has the

authority, without action or vote of our stockholders, to issue all or a part of our authorized but unissued shares.

Such stock issuances could be made at a price that reflects a discount to, or a premium from, the then-current market price of our

common stock.

As described above, we have recently defended a consolidated federal securities class action lawsuit and a consolidated shareholder derivative actions, and we may become involved in additional instances of this type of litigation in the future.

Litigation often is expensive and diverts management’s attention and resources, which could materially and adversely affect our business.

Additionally, fluctuations in the trading price or liquidity of our common stock may materially and adversely affect, among other things, the interest of investors to purchase our common stock on the open market and, generally, our ability to raise capital.

Our board of directors has the power to designate, without stockholder approval, additional series of preferred capital, the shares of which could be senior to our common stock and be entitled to conversion or voting rights that adversely affect the holders of our common stock.

Our articles of incorporation authorize the issuance of capital stock including 20,000,000 authorized undesignated shares (all have been designated as of December 31, 2020), and empowers our board of directors to prescribe, by resolution and without stockholder approval, a class or series of undesignated shares, including the number of shares in the class or series and the voting powers, designations, rights, preferences, restrictions and the relative rights in each such class or series.

Accordingly, we may designate and issue additional shares or series of preferred stock that would rank senior to the shares of common stock as to dividend rights or rights upon our liquidation, winding-up,

or dissolution.

Nevada law and our charter documents could make it more difficult for a third party to acquire us and discourage a takeover, which could depress the trading price of our common stock.

Nevada corporate law and our articles of incorporation and bylaws contain provisions that could discourage, delay, or prevent a change in control of our Company or changes in our management that our stockholders may deem advantageous.

For example, holders of our common stock do not have cumulative voting rights in the election of directors, meaning that stockholders owning a majority of our outstanding shares of common stock will be able to elect all of our directors.

In addition, because if and when we have 200 or more stockholders of record, we are subject to the “business combinations” provisions of the Nevada Revised Statutes, or NRS.

These provisions could prohibit or delay a merger or other takeover or change in control attempt and, accordingly, may discourage attempts to acquire our Company even though such a transaction may be in our stockholders’ best interest and offer our stockholders the opportunity to sell their stock at a price above the prevailing market price.

We may issue additional common stock, which might dilute the net tangible book value per share of our common stock.

Our board of directors has the authority, without action or vote of our stockholders, to issue all or a part of our authorized but unissued shares.

Such stock issuances could be made at a price that reflects a discount to, or a premium from, the then-current market price of our common stock.

In addition, in order to raise capital, we may need to issue securities that are convertible into or exchangeable for a significant amount of our common stock.

We are currently contemplating additional capital raising transactions

within the next twelve months, which would likely result in issuances of additional shares which would be dilutive to current shareholders.

These issuances would dilute the percentage ownership interest, which would have the effect of reducing your

influence on matters on which our stockholders vote, and might dilute the net tangible book value per share of our common stock.

You may incur additional dilution if holders of stock options, whether currently outstanding or subsequently granted,

exercise their options, or if the holders of warrants, whether currently outstanding or subsequently granted, exercise their warrants to purchase shares of our common stock.

We may engage in additional capital raising transactions within the next twelve months, which would likely result in issuances of additional shares which would be dilutive to current shareholders.

These issuances would dilute the percentage ownership interest, which would have the effect of reducing your influence on matters on which our stockholders vote, and might dilute the net tangible book value per share of our common stock.

You may incur additional dilution if holders of stock options, whether currently outstanding or subsequently granted, exercise their options, or if the holders of warrants, whether currently outstanding or subsequently granted, exercise their warrants to purchase shares of our common stock.

A sale of a substantial number of shares of the common stock may cause the price of our common stock to decline.

Finance transactions resulting in a large amount of newly issued shares that become readily tradable, or other events that cause current stockholders to sell

shares, could place downward pressure on the trading price of our stock.

Finance transactions resulting in a large amount of newly issued shares that become readily tradable, or other events that cause current stockholders to sell shares, could place downward pressure on the trading price of our stock.

Some of our shareholders have registration rights to facilitate sales of large blocks of our common stock.

We have filed a shelf registration statement to allow registered

sales by us of up to $100 million.

We have filed a shelf registration statement to allow registered sales by us of up to $100 million, which includes the offer and sell shares of our common stock having an aggregate offering price of up to $40,000,000 from time to time pursuant to our At The Market Issuance Sales Agreement with H.C.

Wainwright & Co., LLC.

We may consider additional or other capital raising transactions within the next twelve months, which would likely result in issuances of additional shares that would be dilutive to current shareholders.

addition, the lack of a robust resale market may require a stockholder who desires to sell a large number of shares of common stock to sell the shares in increments over time to mitigate any adverse impact of the sales on the market price of our

If our stockholders sell, or the market perceives that our stockholders intend to sell for various reasons substantial amounts of our common stock

in the public market, including shares issued upon the exercise of outstanding options or warrants, the market price of our common stock could fall.

Sales of a substantial number of shares of our common stock may make it more difficult for us to

sell equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate.

In addition, the lack of a robust resale market may require a stockholder who desires to sell a large number of shares of common stock to sell the shares in increments over time to mitigate any adverse impact of the sales on the market price of our stock.

If our stockholders sell, or the market perceives that our stockholders intend to sell for various reasons substantial amounts of our common stock in the public market, including shares issued upon the exercise of outstanding options or warrants, the market price of our common stock could fall.

Sales of a substantial number of shares of our common stock may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate.

We may become involved in securities class action litigation that could divert management’s attention and harm our business.

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We have never paid cash dividends on our common stock and do not anticipate paying cash dividends on our common stock in the foreseeable future.

The payment of

dividends on our common stock will depend on our earnings, financial condition and other business and economic factors affecting us at such time as the board of directors may consider relevant.

If we do not pay dividends, our common stock may be

less valuable because a return on your investment will only occur if the market price of our common stock price appreciates.

At times, our shares

of common stock and warrants have been thinly traded, so you may be unable to sell at or near ask prices or even at all if you need to sell your shares to raise money or otherwise desire to liquidate your shares.

The payment of dividends on our common stock will depend on our earnings, financial condition and other business and economic factors affecting us at such time as the board of directors may consider relevant.

If we do not pay dividends, our common stock may be less valuable because a return on your investment will only occur if the market price of our common stock price appreciates.

At times, our shares of common stock and warrants have been thinly traded, so you may be unable to sell at or near ask prices or even at all if you need to sell your shares to raise money or otherwise desire to liquidate your shares.

We cannot predict the extent to which an active public market for our common stock will develop or be sustained.

Our common stock is currently traded on The

NASDAQ Capital Market and experiences periods when

it could be considered thinly-traded. This situation may be attributable to a number of factors, including the fact that we are a small company that is relatively unknown to stock

analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to be risk averse and would be reluctant to follow

an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable.

As a consequence, there may be periods of several days, weeks or months when trading activity in our shares

is minimal, as compared to a seasoned issuer that has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price.

We cannot give you any assurance that a broader or more active

public trading market for our common stock will be sustained, or that current trading levels will be sustained or not diminish.

Concentration of

ownership by our principal stockholders may limit your ability to influence the outcome of director elections and other transactions requiring stockholder approval.

Our common stock is currently traded on The NASDAQ Capital Market and experiences periods when it could be considered “thinly-traded.” This situation may be attributable to a number of factors, including the fact that we are a small company that is relatively unknown to stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to be risk averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable.

As a consequence, there may be periods of several days, weeks or months when trading activity in our shares is minimal, as compared to a seasoned issuer that has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price.

We cannot give you any assurance that a broader or more active public trading market for our common stock will be sustained, or that current trading levels will be sustained or not diminish.

Concentration of ownership by our principal stockholders may limit your ability to influence the outcome of director elections and other transactions requiring stockholder approval.

A significant percentage of our outstanding stock is held by a limited number of investors, including Richard E.

Uihlein, the chairman of our

board of directors, who beneficially owns approximately 13.9% of our outstanding common stock as of February 20, 2020 (which does not include any shares issuable upon exercise of options and warrants) and the 10X Fund, LP , which now owns 11.2%

of the issued and outstanding shares of common stock of the Company as of February 21, 2020 (which does not include any shares issuable upon exercise of options and warrants).

Uihlein is also an investor in the 10X Fund as a

limited partner but is not deemed to be a beneficial owner of, or have a reportable interest in, any shares owned by 10X Fund.

Uihlein, the chairman of our board of directors, who beneficially owns approximately 13.9% of our outstanding common stock as of February 28, 2021 (which does not include any shares issuable upon exercise of options and warrants) and the 10X Fund, LP , which now owns 11.1% of the issued and outstanding shares of common stock of the Company as of February 28, 2021 (which does not include any shares issuable upon exercise of options and warrants).

Uihlein is also an investor in the 10X Fund as a limited partner but is not deemed to be a beneficial owner of, or have a reportable interest in, any shares owned by 10X Fund.

As a result of their ownership of shares of common stock, Mr.

Uihlein and 10X Fund have and will have significant

influence over corporate actions requiring stockholder approval, including the following actions:

Uihlein and 10X Fund have and will have significant influence over corporate actions requiring stockholder approval, including the following actions:

to elect or defeat the election of our directors;

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to control the outcome of any other matter submitted to our stockholders for vote.

Such persons stock ownership may discourage a potential acquirer from making a tender offer or otherwise attempting to obtain control of our company,

which in turn could reduce our stock price or prevent our stockholders from realizing a premium over our stock price.

Uihleins and

10X Funds significant ownership positions may deter or prevent efforts by other companies to acquire us, which could prevent our stockholders from realizing a control premium.

Such persons’ stock ownership may discourage a potential acquirer from making a tender offer or otherwise attempting to obtain control of our company, which in turn could reduce our stock price or prevent our stockholders from realizing a premium over our stock price.

Uihlein’s and 10X Fund’s significant ownership positions may deter or prevent efforts by other companies to acquire us, which could prevent our stockholders from realizing a control premium.

As a result of Mr.

Uihlein’s and 10X Fund’s significant ownership and Mr.

Uihleins position as chairman of the board of directors,

other companies may be less inclined to pursue an acquisition of us or we may not have the opportunity to be acquired in a transaction that stockholders might otherwise deem favorable, including transactions in which our stockholders might realize a

substantial premium for their shares.

Uilhlein and/or 10X Fund could sell or transfer a substantial number of shares of our common

stock, which could depress the price of our securities or result in a change in control of our company.

Uihlein has held common

stock of the Company since 2012 and has not sold any of the shares of common stock that he has acquired during this time period, and although 10X Fund has been a long-time investor in the Company, neither Mr.

Uihlein nor 10X Fund are subject to

any contractual restrictions with us on their ability to sell or transfer our common stock on the open market, in privately negotiated transactions or otherwise, and these sales or transfers could create substantial declines in the price of our

securities or, if these sales or transfers were made to a single buyer or group of buyers, could contribute to a transfer of control of our company to a third party.

Uihlein or 10X Fund of a substantial number of shares, or the

expectation of such sales, could cause a significant reduction in the market price of our common stock.

Uihlein’s position as chairman of the board of directors, other companies may be less inclined to pursue an acquisition of us or we may not have the opportunity to be acquired in a transaction that stockholders might otherwise deem favorable, including transactions in which our stockholders might realize a substantial premium for their shares.

Uilhlein and/or 10X Fund could sell or transfer a substantial number of shares of our common stock, which could depress the price of our securities or result in a change in control of our company.

Uihlein has held common stock of the Company since 2012 and has not sold any of the shares of common stock that he has acquired during this time period, and although 10X Fund has been a long-time investor in the Company, neither Mr.

Uihlein nor 10X Fund are subject to any contractual restrictions with us on their ability to sell or transfer our common stock on the open market, in privately negotiated transactions or otherwise, and these sales or transfers could create substantial declines in the price of our securities or, if these sales or transfers were made to a single buyer or group of buyers, could contribute to a transfer of control of our company to a third party.

Uihlein or 10X Fund of a substantial number of shares, or the expectation of such sales, could cause a significant reduction in the market price of our common stock.

The outbreak of the novel strain of coronavirus, SARS-CoV-2,

which causes COVID-19,

could adversely impact our business, including our preclinical studies and clinical trials.

In response to the spread of COVID-19,

we have closed our executive offices with our administrative employees continuing their work outside of our offices, restricted on-site

staff to only those required to execute their job responsibilities and limited the number of staff in any given research and development laboratory.

As a result of the COVID-19

outbreak, or similar future pandemics, we have and may in the future experience disruptions that could severely impact our business and our anticipated rollout and/or continuation of our NAVIGATE trial, including:

delays or difficulties in enrolling patients in our clinical trials;

delays or disruptions in non-clinical

experiments due to unforeseen circumstances at contract research organizations and vendors along their supply chain;

increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19,

being forced to quarantine, or not accepting in office or home health visits;

diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as sites for our NAVIGATE trial and hospital staff supporting the conduct of such trials;

interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures (particularly any procedures that may be deemed non-essential),

which may impact the integrity of subject data and clinical study endpoints;

interruption or delays in the operations of the FDA and comparable foreign regulatory agencies, which may impact review and approval timelines;

interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;

limitations on employee resources that would otherwise be focused on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families, the desire of employees to avoid contact with large groups of people, an increased reliance on working from home or mass transit disruptions.

These and other factors arising from the COVID-19

pandemic could worsen in countries that are already afflicted with COVID-19,

could continue to spread to additional countries, or could return to countries where the pandemic has been partially contained, each of which could further adversely impact our ability to conduct clinical trials and our business generally, and could have a material adverse impact on our operations and financial condition and results.

In addition, the trading prices for our common stock and other biopharmaceutical companies have been highly volatile as a result of the COVID-19

As a result, we may face difficulties raising capital through sales of our common stock or such sales may be on unfavorable terms.

outbreak continues to rapidly evolve.

The extent to which the outbreak may impact our business, preclinical studies and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and actions to contain the outbreak or treat its impact, such as social distancing and quarantines or lock-downs in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

Unresolved Staff Comments

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors