6 unchanged sentences
Risks Related to Our Business
−Removed: We are a development stage company and may never earn a profit.
−Removed: We are a development stage company and have incurred losses since our formation.
+Added: We are a clinical stage company and may never earn a profit.
+Added: We are a clinical stage company and have incurred losses since our formation.
As of December 31, 2020, we have an accumulated total deficit of approximately $231.5 million.
−Removed: For the fiscal years ended December 31, 2019 and 2018 , we
−Removed: had a net loss attributable to common stockholders of approximately $16.7 million and $19.3 million , respectively.
+Added: For the fiscal years ended December 31, 2020 and 2019, we had a net loss attributable to common stockholders of approximately $22.6 million and $16.7 million, respectively.
To date, we have experienced negative cash flow from development of our product candidate, onvansertib.
14 unchanged sentences
Failure to obtain additional capital at acceptable terms would result in a material and adverse impact on our operations.
−Removed: Our financial statements include an explanatory paragraph that expresses substantial doubt about our ability to continue as a going concern, indicating the possibility that we may not be able to operate in the future.
−Removed: Primarily as a result of our losses incurred to date, our expected continued future losses, and limited cash balances, we have included an explanatory paragraph in our financial statements expressing substantial doubt about our ability to continue as a going concern.
−Removed: Our ability to continue as a going concern is contingent upon, among other factors, the sale of the shares of our common stock or obtaining alternate financing.
−Removed: Our product candidate, onvansertib, is in the early stages of development and its commercial viability remains subject to current and future preclinical studies, clinical trials, regulatory approvals and the risks generally inherent in the development of a pharmaceutical product candidate.
+Added: Our product candidate, onvansertib, is in the early stages of clinical development and its commercial viability remains subject to current and future preclinical studies, clinical trials, regulatory approvals and the risks generally inherent in the development of a pharmaceutical product candidate.
If we are unable to successfully advance or develop our product candidate, our business will be materially harmed.
61 unchanged sentences
The regulatory review and approval process can take many years, is dependent upon the type, complexity, novelty of, and medical need for the product candidate, requires the expenditure of substantial resources, and involves post-marketing surveillance and vigilance and ongoing requirements for post-marketing studies or Phase 4 clinical trials.
−Removed: In addition, we or our collaborators may encounter delays in, or fail to gain, regulatory approval for our product candidate based upon additional governmental regulation resulting from future legislative, administrative action or changes in FDA’s or other similar foreign regulatory authorities’ policy or interpretation during the period of product development.
+Added: In addition, we or our collaborators may encounter delays in, or fail to gain, regulatory approval for our product candidate based upon additional governmental
+Added: regulation resulting from future legislative, administrative action or changes in FDA’s or other similar foreign regulatory authorities’ policy or interpretation during the period of product development.
Delays or failures in obtaining regulatory approval to advance our product candidate through clinical development, and ultimately commercialize them, may:
22 unchanged sentences
In order to develop our product candidate, we need to retain or attract certain personnel, consultants or advisors with experience in drug development activities that include a number of disciplines, including research and development, clinical trials, medical matters, government regulation of pharmaceuticals, manufacturing, formulation and chemistry, business development, accounting, finance, regulatory affairs, human resources and information systems.
−Removed: We are highly dependent upon our senior management and scientific staff, particularly Thomas H.
−Removed: Adams, Ph.D., our Chairman and Chief Executive Officer (“CEO”).
+Added: We are highly dependent upon our senior management and scientific staff, particularly Mark Erlander, our Chief Executive Officer (“CEO”).
The loss of services of Dr.
−Removed: Adams or one or more of our other members of senior management could delay or prevent the successful completion of our planned clinical trials or the commercialization of our product candidate.
+Added: Erlander or one or more of our other members of senior management could delay or prevent the successful completion of our planned clinical trials or the commercialization of our product candidate.
Our success depends in part on our continued ability to attract, retain and motivate highly qualified management, clinical and scientific personnel and on our ability to develop and maintain important relationships with leading academic institutions, clinicians and scientists.
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We do not know whether planned clinical trials will begin on time, will need to be redesigned or will be completed on schedule, if at all.
−Removed: Clinical trials can be delayed for a variety of reasons, including delays in obtaining regulatory approval to commence a clinical trial, in securing clinical trial agreements with prospective sites with acceptable terms, in obtaining institutional review board approval to conduct a clinical
−Removed: trial at a prospective site, in recruiting patients to participate in a clinical trial or in obtaining sufficient supplies of clinical trial materials.
+Added: Clinical trials can be delayed for a variety of reasons, including delays in obtaining regulatory approval to commence a clinical trial, in securing clinical trial agreements with prospective sites with acceptable terms, in obtaining institutional review board approval to conduct a clinical trial at a prospective site, in recruiting patients to participate in a clinical trial or in obtaining sufficient supplies of clinical trial materials.
Many factors affect patient enrollment, including the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial, competing clinical trials and new drugs approved for the conditions we are investigating.
19 unchanged sentences
Further, our product candidate may not receive regulatory approval even if it is successful in clinical trials.
−Removed: If we do not receive regulatory approvals for our product candidate, we may not be able to continue our
+Added: If we do not receive regulatory approvals for our product candidate, we may not be able to continue our operations.
Even if we successfully obtain regulatory approvals to market one or more of our product candidates, our revenues will be dependent, in part, upon our collaborators’ ability to obtain regulatory approval of the companion diagnostics to be used with our product candidates, as well as the size of the markets in the territories for which we gain regulatory approval and have commercial rights.
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To receive approval, we must, among other things, demonstrate with substantial evidence from well-designed and well-controlled pre- clinical testing and clinical trials that the product candidate is both safe and effective for each indication for which approval is sought.
−Removed: Satisfaction of these requirements typically takes several years and the time needed to satisfy them may vary substantially, based on the type, complexity and novelty of the pharmaceutical product.
+Added: Satisfaction of these requirements typically takes several years and the time needed to satisfy them may vary
+Added: substantially, based on the type, complexity and novelty of the pharmaceutical product.
We cannot predict if or when we will submit an NDA for approval for our product candidate currently under development.
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Our commercial opportunity will be reduced or eliminated if our competitors develop and commercialize any drugs that are safer, more effective, have fewer side effects or are less expensive than our product candidate.
−Removed: These potential competitors compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical
−Removed: trial sites and patient enrollment for clinical trials, as well as in acquiring technologies and technology licenses complementary to our programs or advantageous to our business.
+Added: These potential competitors compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient enrollment for clinical trials, as well as in acquiring technologies and technology licenses complementary to our programs or advantageous to our business.
If approved and commercialized, onvansertib would compete with several currently approved prescription therapies for the treatment of AML.
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We will be responsible for ensuring that each of our future contract manufacturers comply with the GMP requirements of the FDA and other regulatory authorities from which we seek to obtain product approval.
−Removed: These requirements include,
−Removed: among other things, quality control, quality assurance and the maintenance of records and documentation.
+Added: These requirements include, among other things, quality control, quality assurance and the maintenance of records and documentation.
The approval process for NDAs includes a review of the manufacturer’s compliance with GMP requirements.
8 unchanged sentences
To date, our product candidate has been manufactured in small quantities for preclinical studies and clinical trials.
−Removed: If our product candidate is approved by the FDA or comparable regulatory authorities in other countries for commercial sale, we will need to manufacture such product candidate in larger quantities.
+Added: If our product candidate is approved by the FDA or comparable regulatory authorities in other countries for commercial sale, we
+Added: will need to manufacture such product candidate in larger quantities.
We may not be able to increase successfully the manufacturing capacity for our product candidate in a timely or economic manner, or at all.
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If any product candidate is approved but does not achieve an adequate level of acceptance by physicians, patients and third-party payors, our ability to generate revenues from that product would be substantially reduced.
−Removed: In addition, our efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources, may be constrained by FDA rules and policies on product promotion, and may never be successful.
+Added: In addition, our efforts to educate the
+Added: medical community and third-party payors on the benefits of our product candidates may require significant resources, may be constrained by FDA rules and policies on product promotion, and may never be successful.
Guidelines and recommendations published by various organizations can impact the use of our product.
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Due to regulatory restrictions inherent in an IND, NDA or BLA, various steps in the manufacture of our product candidate may need to be sole-sourced.
−Removed: In accordance with cGMPs, changing manufacturers may require the re-validation of manufacturing processes and procedures, and may require further preclinical studies or clinical trials to show comparability between the materials produced by different manufacturers.
+Added: In accordance with CGMPs, changing manufacturers may require the re-validation of
+Added: manufacturing processes and procedures, and may require further preclinical studies or clinical trials to show comparability between the materials produced by different manufacturers.
Changing our current or future contract manufacturers may be difficult for us and could be costly, which could result in our inability to manufacture our product candidate for an extended period of time and therefore a delay in the development of our product candidate.
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We may delay or terminate the development of our product candidate at any time if we believe the perceived market or commercial opportunity does not justify further investment, which could materially harm our business.
−Removed: Even though the results of preclinical studies and clinical trials that have been conducted or may conduct in the future may support further development of our product candidate, we may delay, suspend or terminate the future development of a product candidate at any time for strategic, business, financial or other reasons, including the determination or belief that the emerging profile of the product candidate is such that it may not receive FDA approval, gain meaningful market acceptance, generate a significant return to shareholders, or otherwise provide any competitive advantages in its intended indication or market.
+Added: Even though the results of preclinical studies and clinical trials that have been conducted or may conduct in the future may support further development of our product candidate, we may delay, suspend or terminate the future development of a product candidate at any time for strategic, business, financial or other reasons, including the determination or belief that the
+Added: emerging profile of the product candidate is such that it may not receive FDA approval, gain meaningful market acceptance, generate a significant return to shareholders, or otherwise provide any competitive advantages in its intended indication or market.
We will need to increase the size of our organization, and we may experience difficulties in managing growth.
14 unchanged sentences
These and other natural disasters could severely disrupt our operations, and have a material adverse effect on our business, results of operations, financial condition and prospects.
−Removed: If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as the manufacturing facilities of
−Removed: our third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time.
+Added: If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time.
Any disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event.
8 unchanged sentences
It is essential to our business strategy that our technology and network infrastructure and our physical buildings remain secure and are perceived by our customers and corporate partners to be secure.
−Removed: Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security threats.
+Added: Despite security measures, however, any
+Added: network infrastructure may be vulnerable to cyber-attacks by hackers and other security threats.
We may face cyber-attacks that attempt to penetrate our network security, sabotage or otherwise disable our research, products and services, misappropriate our or our customers’ and partners’ proprietary information, which may include personally identifiable information, or cause interruptions of our internal systems and services.
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and other countries have contributed to increased volatility and diminished expectations for the global economy.
−Removed: If the economic climate does not improve, or if it deteriorates, our business, including our access to patient samples and the addressable market for tests that we may successfully develop, as well as the
−Removed: financial condition of our suppliers and our third-party payors, could be negatively impacted, which could materially adversely affect our business, prospects and financial condition.
−Removed: We incur significant costs as a result of operating as a public company and our management expects to continue to devote substantial time to public company compliance programs.
−Removed: As a public company, we incur significant legal, accounting and other expenses due to our compliance with regulations and disclosure obligations applicable to us, including compliance with the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, as well as rules implemented by the SEC, and the Nasdaq Stock Market LLC (“Nasdaq”).
−Removed: The SEC and other regulators have continued to adopt new rules and regulations and make additional changes to existing regulations that require our compliance.
−Removed: For example, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”) was enacted.
−Removed: There is significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that have required the SEC to adopt additional rules and regulations in these areas.
−Removed: Stockholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact (in ways we cannot currently anticipate) the manner in which we operate our business.
−Removed: Our management and other personnel devote a substantial amount of time to these compliance programs and monitoring of public company reporting obligations and, as a result of the new corporate governance and executive compensation related rules, regulations and guidelines prompted by the Dodd-Frank Act and further regulations and disclosure obligations expected in the future, we will likely need to devote additional time and costs to comply with such compliance programs and rules.
−Removed: These rules and regulations will continue to cause us to incur significant legal and financial compliance costs and will make some activities more time-consuming and costly.
−Removed: We may become subject to federal and state tax assessments, penalties and interest with respect to past compensation paid to certain of our executives.
−Removed: During our internal review process, contingencies were identified regarding various federal and state tax exposures with respect to past compensation paid to certain of our executives.
−Removed: We have not recorded any accrued liabilities related to the potential federal and state tax exposure.
−Removed: If we become subject to any material tax assessment, penalties and interest by federal and state tax authorities in the future, our results of operations, financial performance and cash flows could be materially adversely affected.
+Added: If the economic climate does not improve, or if it deteriorates, our business, including our access to patient samples and the addressable market for tests that we may successfully develop, as well as the financial condition of our suppliers and our third-party payors, could be negatively impacted, which could materially adversely affect our business, prospects and financial condition.
If we use biological and hazardous materials in a manner that causes injury, we could be liable for damages.
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Some of the provisions of the PPACA have yet to be implemented, and there have been legal and political challenges to certain aspects of the PPACA.
−Removed: Since January 2017, President Trump has signed two executive orders and other directives designed to delay, circumvent, or loosen certain requirements mandated by the PPACA.
+Added: During President Trump's administration, he signed two executive orders and other directives designed to delay, circumvent, or loosen certain requirements mandated by the PPACA.
Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the PPACA.
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A biosimilar is a biological product that is highly similar to an approved drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the approved drug in terms of the safety, purity, and potency of the product.
−Removed: Individual states have become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and to encourage importation from other countries and bulk purchasing.
+Added: Individual states have become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and to encourage importation
+Added: from other countries and bulk purchasing.
Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition and prospects.
In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.
−Removed: This could reduce ultimate demand
−Removed: for our products or put pressure on our product pricing, which could negatively affect our business, results of operations, financial condition and prospects.
+Added: This could reduce ultimate demand for our products or put pressure on our product pricing, which could negatively affect our business, results of operations, financial condition and prospects.
In addition, given recent federal and state government initiatives directed at lowering the total cost of healthcare, Congress and state legislatures will likely continue to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs.
7 unchanged sentences
For example, average review times at the FDA for marketing approval applications can be affected by a variety of factors, including budget and funding levels and statutory, regulatory and policy changes.
+Added: The outbreak of the novel coronavirus disease, COVID-19, could materially adversely impact our business, results of operations and financial condition, including our clinical trials.
+Added: In January 2020, the World Health Organization declared the outbreak of COVID-19 as a “Public Health Emergency of International Concern,” which continues to spread throughout the world and has adversely impacted global commercial activity and contributed to significant declines and volatility in financial markets.
+Added: The COVID-19 outbreak and government responses are creating disruption in global supply chains and adversely impacting many industries.
+Added: The outbreak could have a continued material adverse impact on economic and market conditions and trigger a period of global economic slowdown.
+Added: We continue to monitor the impact of the COVID-19 outbreak closely.
+Added: The extent to which the COVID-19 outbreak will impact our operations or financial results is uncertain.
+Added: The outbreak and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred;
+Added: supply chains have been disrupted;
+Added: facilities and production have been suspended;
+Added: and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen.
+Added: While the extent of the impact of the COVID-19 pandemic on our business and financial results is uncertain, a continued and prolonged public health crisis such as the COVID-19 pandemic could have a material adverse effect on our business, financial condition and results of operations.
+Added: As a result of the COVID-19 pandemic, we may experience disruptions that could severely impact our business and clinical trials, including:
+Added: • delays or difficulties in enrolling and retaining patients in our clinical trials;
+Added: • delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
+Added: • diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;
+Added: • 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 (such as endoscopies that are deemed non-essential), which may impact the integrity of subject data and clinical study endpoints;
+Added: • interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;
+Added: • interruption of, or delays in receiving, supplies of our product candidate from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;
+Added: • limitations on employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;
+Added: • interruption or delays to our sourced clinical activities;
+Added: • changes in clinical site procedures and requirements as well as regulatory requirements for conducting clinical trials during the pandemic.
+Added: We may be required to develop and implement additional clinical trial policies and procedures designed to help protect subjects from the COVID-19 virus.
+Added: For example, in March 2020, the FDA issued guidance, which FDA subsequently updated, on conducting clinical trials during the pandemic, which describes a number of considerations for sponsors of clinical trials impacted by the pandemic, including the requirement to include in the clinical trial report contingency measures implemented to manage the trial, and any disruption of the trial as a result of the COVID-19 pandemic;
+Added: a list of all subjects affected by the COVID-19 pandemic related study disruption by unique subject identifier and by investigational site and a description of how the individual’s participation was altered;
+Added: and analyses and corresponding discussions that address the impact of implemented contingency measures (e.g., participant discontinuation from investigational product and/or study, alternative procedures used to collect critical safety and/or efficacy data) on the safety and efficacy results reported for the trial.
+Added: The COVID-19 pandemic continues to evolve rapidly, with the status of operations and government restrictions evolving weekly.
+Added: The extent to which the outbreak impacts our business and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the pandemic, travel restrictions and social distancing 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.
+Added: The ultimate impact of the COVID-19 pandemic on our business operations is highly uncertain and subject to change and will depend on future developments, which cannot be accurately predicted, including the duration of the pandemic, the ultimate geographic spread of the disease, additional or modified government actions, new information that will emerge concerning the severity and impact of COVID-19 and the actions taken to contain COVID-19 or address its impact in the short and long term, among others.
+Added: We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems or the global economy.
+Added: We will continue to monitor the situation closely.
+Added: In addition, our business could be materially adversely affected by other business disruptions to us or our third-party providers that could materially adversely affect our potential future revenue and financial condition and increase our costs and expenses.
+Added: Our operations, and those of our contract research organizations ("CROs"), contract manufacturing organizations ("CMOs"), and other contractors, consultants and third parties could be subject to other global pandemics, earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics and other natural or man-made disasters or business interruptions, for which we are predominantly self-insured.
+Added: The occurrence of any of these business disruptions could materially adversely affect our operations and financial condition and increase our costs and expenses.
+Added: We rely on third-party manufacturers to produce and process our product candidate.
+Added: Our ability to obtain clinical supplies of our product candidate could be disrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business interruption.
Risks Related to Our Intellectual Property
38 unchanged sentences
Our competitors may have filed, and may in the future file, patent applications covering technology similar to ours.
−Removed: 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.
+Added: Any such patent application may have priority over our patent applications and could further require us to obtain rights to
+Added: issued patents covering such technologies.
There may be third-party patents, patent applications and other intellectual property relevant to our potential products that may block or compete with our potential products or processes.
15 unchanged sentences
Risks Related to Ownership of Our Common Stock
−Removed: If we discover material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult.
−Removed: If we fail to comply with the rules under the Sarbanes-Oxley Act, related to disclosure controls and procedures, or if we discover additional material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult.
−Removed: Moreover, effective internal controls are necessary for us to produce reliable financial reports and are important in helping prevent financial fraud.
−Removed: If we cannot provide reliable financial reports or prevent fraud, our business and operating results could be harmed, investors could lose confidence in our reported financial information, and the trading price of our common stock could drop significantly.
−Removed: We previously identified a material weakness in our internal control over financial reporting, which was subsequently remedied.
−Removed: We cannot be certain that additional material weaknesses or significant deficiencies in our internal controls will not be discovered in the future.
Our ability to use our net operating loss carryforwards and certain other tax attributes is limited by Sections 382 and 383 of the Internal Revenue Code.
37 unchanged sentences
• economic and other external factors;
+Added: • catastrophic weather and/or global disease outbreaks, such as the recent COVID-19 pandemic;
• period-to-period fluctuations in our financial results.
14 unchanged sentences
If one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline.
−Removed: In addition, if our operating results fail to meet
−Removed: the forecast of analysts, our stock price would likely decline.
+Added: In addition, if our operating results fail to meet the forecast of analysts, our stock price would likely decline.
If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
6 unchanged sentences
A sale of a substantial number of shares of our common stock may cause the price of our common stock to decline and may impair our ability to raise capital in the future.
−Removed: Our common stock is traded on The Nasdaq Capital Market and could be considered “thinly-traded,” meaning that the number of investors interested in purchasing our common stock at or near bid prices at any given time may be relatively small or non-existent.
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 common stock.
11 unchanged sentences
If we fail to comply with the continued minimum closing bid requirements of the Nasdaq or other requirements for continued listing, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
−Removed: On September 7, 2018, we received a letter from Nasdaq indicating that, based upon our continued non-compliance with the Minimum Bid Price Rule, our common stock would be subject to delisting unless we requested a hearing before a Nasdaq Hearings Panel.
−Removed: We timely requested a hearing before the Panel which was held on November 8, 2018.
−Removed: On November 15, 2018, we announced that the Panel granted our request for continued listing on The Nasdaq Capital Market, subject to effecting a reverse stock split of our common stock and evidencing a closing bid price of over $1.00 for at least 10
−Removed: consecutive trading days.
−Removed: On February 12, 2019, we announced that our stockholders approved a reverse stock split of our issued and outstanding shares of common stock and on February 19, 2019, we effected a six for one reverse stock split of our issued and outstanding shares of common stock.
−Removed: On March 11, 2019 we received a letter from Nasdaq, informing us that we had regained compliance with the minimum bid price requirement.
−Removed: We remain subject to a Nasdaq Panel Monitor until March 10, 2020.
If we do not maintain compliance with Nasdaq requirements for continued listing or fail to comply with other requirements for continued listing, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
1 unchanged sentence
In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, employees and fewer business development opportunities.
+Added: General Risk Factors
+Added: If we discover material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult.
+Added: If we fail to comply with the rules under the Sarbanes-Oxley Act, related to disclosure controls and procedures, or if we discover additional material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult.
+Added: Moreover, effective internal controls are necessary for us to produce reliable financial reports and are important in helping prevent financial fraud.
+Added: If we cannot provide reliable financial reports or prevent fraud, our business and operating results could be harmed, investors could lose confidence in our reported financial information, and the trading price of our common stock could drop significantly.
+Added: We previously identified a material weakness in our internal control over financial reporting, which was subsequently remedied.
+Added: We cannot be certain that additional material weaknesses or significant deficiencies in our internal controls will not be discovered in the future.
+Added: We incur significant costs as a result of operating as a public company and our management expects to continue to devote substantial time to public company compliance programs.
+Added: As a public company, we incur significant legal, accounting and other expenses due to our compliance with regulations and disclosure obligations applicable to us, including compliance with the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, as well as rules implemented by the SEC, and the Nasdaq Stock Market LLC (“Nasdaq”).
+Added: The SEC and other regulators have continued to adopt new rules and regulations and make additional changes to existing regulations that require our compliance.
+Added: For example, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”) was enacted.
+Added: There is significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that have required the SEC to adopt additional rules and regulations in these areas.
+Added: Stockholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact (in ways we cannot currently anticipate) the manner in which we operate our business.
+Added: Our management and other personnel devote a substantial amount of time to these compliance programs and monitoring of public company reporting obligations and, as a result of the new corporate governance and executive compensation related rules, regulations and guidelines prompted by the Dodd-Frank Act and further regulations and disclosure obligations expected in the future, we will likely need to devote additional time and costs to comply with such compliance programs and rules.
+Added: These rules and regulations will continue to cause us to incur significant legal and financial compliance costs and will make some activities more time-consuming and costly.
UNRESOLVED STAFF COMMENTS
+Added: We currently lease laboratory and office space for our headquarters in San Diego, California under a lease agreement, as amended from time to time, that expires in December 2021.
+Added: We (as a sublessor) also sublease portions of our facility to third parties under three separate subleases.
+Added: We believe that our facilities are adequate for our current and near-term needs.
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.