overview we are a clinical stage pharmaceutical company focused on developing and commercializing innovative therapeutics to treat patients suffering from rare seizure disorders . our clinical stage product candidate , ganaxolone , is a positive allosteric modulator of gaba a that is being developed in formulations for two different routes of administration : intravenous ( iv ) and oral . ganaxolone is a synthetic analog of allopregnanolone , an endogenous neurosteroid . the different formulations are intended to maximize potential therapeutic applications of ganaxolone for adult and pediatric patient populations , in both acute and chronic care , and for both in-patient and self-administered settings . ganaxolone acts at both synaptic and extrasynaptic gaba a receptors , a target known for its anti-seizure , antidepressant and anxiolytic potential . our operations to date have consisted primarily of organizing and staffing our company , developing ganaxolone , including conducting preclinical studies and clinical trials , and raising capital . we have funded our operations primarily through sales of equity and debt securities . at december 31 , 2020 , we had cash , cash equivalents and investment balances of $ 140.0 million . we have no products currently available for sale , have incurred operating losses since inception , have not generated any product sales revenue and have not achieved profitable operations . we incurred a net loss of $ 67.5 million for the year ended december 31 , 2020. our accumulated deficit as of december 31 , 2020 was $ 311.9 million , and we expect to continue to incur substantial losses in future periods . we anticipate that our operating expenses will increase substantially as we continue to advance our clinical-stage product candidate , ganaxolone . we anticipate that our expenses will increase substantially as we : · conduct later stage clinical trials in targeted indications , which could include se , cdd , tsc , pcdh19-re and possibly other indications ; ● continue the research , development and scale-up manufacturing capabilities to optimize ganaxolone and dose forms for which we may obtain regulatory approval ; ● conduct other preclinical studies and clinical trials to support the filing of ndas with the fda , maas with the ema and other marketing authorization filings with regulatory agencies in other countries ; ● acquire the rights to other product candidates and fund their development ; ● maintain , expand and protect our global intellectual property portfolio ; ● hire additional clinical , manufacturing and scientific personnel ; and ● add operational , financial and management information systems and personnel , including personnel to support our drug development efforts . 78 we believe that our cash , cash equivalents and investment balances as of december 31 , 2020 will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2022. however , we will need to secure additional funding in the future , from one or more equity or debt financings , government funding , collaborations , licensing transactions , other commercial transactions or other sources , in order to carry out all of our planned research and development activities with respect to ganaxolone . covid-19 in december 2019 , an outbreak of a novel strain of coronavirus ( covid-19 ) was identified in wuhan , china . this virus was declared a pandemic by the world health organization in march 2020 and has spread to nearly every country in the world , including the u.s. efforts to contain the spread of covid-19 have intensified and many countries , including the u.s. , have implemented severe travel restrictions , business shutdowns and social distancing measures that have impacted clinical development through supply chain shortages and clinical trial enrollment difficulties as hospitals reduce and redeploy staff , divert resources to patients suffering covid-19 and limit hospital access for non-patients . the pandemic poses the risk that we , our contractors , suppliers , or other partners may be prevented from conducting normal business activities for an indefinite period of time , including those due to shutdowns that may be requested or mandated by governmental authorities . the continued global spread of covid-19 has affected our operations but did not had a material impact on our business , operating results , financial condition or cash flows as of and for the year ended december 31 , 2020. for example , several of our phase 1 trials of oral ganaxolone to support the cdd indication have continued enrollment and are expected to be completed by the end of the second quarter of 2021 , despite experiencing delays in enrollment due to covid-19 . further , in response to covid-19 , for our ongoing clinical trials , we have implemented multiple measures consistent with guidance of the fda on the conduct of clinical trials of medical products during the covid-19 pandemic , including implementing remote site monitoring and remote visits using telemedicine where needed . however , covid-19 may still adversely impact our clinical trials . for example , our raise trial in rse is being conducted in hospitals , and resources related to the covid-19 pandemic may divert staffing in hospitals , taking resources away from our clinical trial . our ganaxolone clinical trials in the outpatient setting may be negatively impacted if patients and their caregivers do not want to participate in a clinical trial while the covid-19 pandemic continues to severely affect the world . story_separator_special_tag further , the continued spread of covid-19 has also led to severe disruption and volatility in the global capital markets , which could increase our cost of capital and adversely affect our ability to access the capital markets in the future . our failure to obtain sufficient funds on acceptable terms when needed could have a negative impact on our business , results of operations , and financial condition . our future capital requirements will depend on many factors , including : ● the effects of the covid-19 pandemic on our business , the medical community and the global economy ; ● the results of our preclinical studies and clinical trials ; ● the development , formulation and commercialization activities related to ganaxolone ; ● the scope , progress , results and costs of researching and developing ganaxolone or any other future product candidates , and conducting preclinical studies and clinical trials ; ● the timing of , and the costs involved in , obtaining regulatory approvals for ganaxolone or any other future product candidates ; ● the cost of commercialization activities if ganaxolone or any other future product candidates are approved for sale , including marketing , sales and distribution costs ; ● the cost of manufacturing and formulating ganaxolone , or any other future product candidates , to internal and regulatory standards for use in preclinical studies , clinical trials and , if approved , commercial sale ; ● our ability to establish and maintain strategic collaborations , licensing or other arrangements and the financial terms of such agreements ; ● our ability to receive funding under the barda contract ; ● any product liability , infringement or other lawsuits related to our product candidates and , if approved , products ; ● capital needed to attract and retain skilled personnel ; ● the costs involved in preparing , filing , prosecuting , maintaining , defending and enforcing patent claims , including litigation costs and the outcome of such litigation ; and ● the timing , receipt and amount of sales of , or royalties on , future approved products , if any . please see “ risk factors ” for additional risks associated with our substantial capital requirements . off-balance sheet arrangements we do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition , changes in financial condition , revenues or expenses , results of operations , liquidity , capital expenditures or capital resources that are material to investors . 84 discussion of critical accounting policies and significant judgments and estimates we base this management 's discussion and analysis of our financial condition and results of operations on our financial statements , which we have prepared in accordance with accounting principles generally accepted in the united states ( gaap ) . the preparation of our financial statements requires us to make estimates and judgments that affect the reported amounts of assets , liabilities , revenue and expenses and the disclosure of contingent assets and liabilities in our financial statements . we evaluate our estimates and judgments , including those related to accrued clinical trial expenses on an ongoing basis . we base our estimates on historical experience , known trends and events and various other factors that we believe to be reasonable under the circumstances , the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources . actual results may differ from these estimates under different assumptions or conditions . you should consider your evaluation of our financial condition and results of operations with these policies , judgments and estimates in mind . while we describe our significant accounting policies in the notes to our financial statements appearing elsewhere in this annual report on form 10-k , we believe the following accounting policies are the most critical to the judgments and estimates we use in the preparation of our financial statements . clinical trial expenses as part of the process of preparing our financial statements , we are required to estimate our clinical trial expenses . our clinical trial accrual process seeks to account for expenses resulting from our obligations under contracts with vendors , consultants and cros and clinical site agreements in connection with conducting clinical trials . the financial terms of these contracts are subject to negotiations , which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts . our objective is to reflect the appropriate clinical trial expenses in our financial statements by matching the appropriate expenses with the period in which services and efforts are expended . we account for these expenses according to the progress of the trial as measured by subject progression and the timing of various aspects of the trial . we determine accrual estimates based on estimates of the services received and efforts expended that take into account discussion with applicable personnel and outside service providers as to the progress or state of completion of trials . during the course of a clinical trial , we adjust our clinical expense recognition if actual results differ from our estimates . we make estimates of our accrued expenses and prepaid assets as of each balance sheet date in our financial statements based on the facts and circumstances known to us at that time . our clinical trial accrual and prepaid assets are dependent , in part , upon the receipt of timely and accurate reporting from cros and other third-party vendors . although we do not expect our estimates to differ materially from amounts we actually incur , our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high

sources of liquidity since inception , we have incurred net losses and negative cash flows from our operations . we incurred a net loss of $ 67.5 million for the year ended december 31 , 2020. our cash used in operating activities was $ 60.9 million for year ended december 31 , 2020 compared to $ 48.6 million for the same period a year ago . historically , we have financed our operations principally through the sale of common stock , notes payable , preferred stock and convertible debt . at december 31 , 2020 , we had cash , cash equivalents and investment balances of $ 140.0 million . in september 2020 , we entered into the barda contract . under the barda contract , we receive d an award of up to an estimated $ 51 million for development of iv- administered ganaxolone for the treatment of rse . the barda contract provides for f unding to support , on a cost-sharing basis , the completion of the raise trial , funding of pre-clinical studies to provide support that iv-administered ganaxolone could be an effective treatment for rse due to chemical nerve gas agent exposure , and funding of certain manufacturing scale-up and regulatory activities . the barda contract consists of an approximately two-year base period-during which barda will provide approximately $ 21 million of funding for the raise trial on a cost share basis and funding of additional preclinical studies of ganaxolone in nerve agent exposure models . following successful completion of the raise trial and preclinical studies in the base period , the barda contract provides for approximately $ 30 million of additional barda funding for three options in support of manufacturing , supply chain , clinical , regulatory and toxicology activities . under the barda contract , we will be responsible for cost sharing in the amount of approximately $ 33 million and barda will be responsible for approximately $ 51 million , if all development options are completed .


 Write a concise suspicious activity report of the following text delimited by triple backquotes. Return your response as a formal report which covers the key points highlighting the location,dates,entity names and account holder information in chronological order of the text.
     ```sources of liquidity since inception , we have incurred net losses and negative cash flows from our operations . we incurred a net loss of $ 67.5 million for the year ended december 31 , 2020. our cash used in operating activities was $ 60.9 million for year ended december 31 , 2020 compared to $ 48.6 million for the same period a year ago . historically , we have financed our operations principally through the sale of common stock , notes payable , preferred stock and convertible debt . at december 31 , 2020 , we had cash , cash equivalents and investment balances of $ 140.0 million . in september 2020 , we entered into the barda contract . under the barda contract , we receive d an award of up to an estimated $ 51 million for development of iv- administered ganaxolone for the treatment of rse . the barda contract provides for f unding to support , on a cost-sharing basis , the completion of the raise trial , funding of pre-clinical studies to provide support that iv-administered ganaxolone could be an effective treatment for rse due to chemical nerve gas agent exposure , and funding of certain manufacturing scale-up and regulatory activities . the barda contract consists of an approximately two-year base period-during which barda will provide approximately $ 21 million of funding for the raise trial on a cost share basis and funding of additional preclinical studies of ganaxolone in nerve agent exposure models . following successful completion of the raise trial and preclinical studies in the base period , the barda contract provides for approximately $ 30 million of additional barda funding for three options in support of manufacturing , supply chain , clinical , regulatory and toxicology activities . under the barda contract , we will be responsible for cost sharing in the amount of approximately $ 33 million and barda will be responsible for approximately $ 51 million , if all development options are completed .
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 Suspicious Activity Report : overview we are a clinical stage pharmaceutical company focused on developing and commercializing innovative therapeutics to treat patients suffering from rare seizure disorders . our clinical stage product candidate , ganaxolone , is a positive allosteric modulator of gaba a that is being developed in formulations for two different routes of administration : intravenous ( iv ) and oral . ganaxolone is a synthetic analog of allopregnanolone , an endogenous neurosteroid . the different formulations are intended to maximize potential therapeutic applications of ganaxolone for adult and pediatric patient populations , in both acute and chronic care , and for both in-patient and self-administered settings . ganaxolone acts at both synaptic and extrasynaptic gaba a receptors , a target known for its anti-seizure , antidepressant and anxiolytic potential . our operations to date have consisted primarily of organizing and staffing our company , developing ganaxolone , including conducting preclinical studies and clinical trials , and raising capital . we have funded our operations primarily through sales of equity and debt securities . at december 31 , 2020 , we had cash , cash equivalents and investment balances of $ 140.0 million . we have no products currently available for sale , have incurred operating losses since inception , have not generated any product sales revenue and have not achieved profitable operations . we incurred a net loss of $ 67.5 million for the year ended december 31 , 2020. our accumulated deficit as of december 31 , 2020 was $ 311.9 million , and we expect to continue to incur substantial losses in future periods . we anticipate that our operating expenses will increase substantially as we continue to advance our clinical-stage product candidate , ganaxolone . we anticipate that our expenses will increase substantially as we : · conduct later stage clinical trials in targeted indications , which could include se , cdd , tsc , pcdh19-re and possibly other indications ; ● continue the research , development and scale-up manufacturing capabilities to optimize ganaxolone and dose forms for which we may obtain regulatory approval ; ● conduct other preclinical studies and clinical trials to support the filing of ndas with the fda , maas with the ema and other marketing authorization filings with regulatory agencies in other countries ; ● acquire the rights to other product candidates and fund their development ; ● maintain , expand and protect our global intellectual property portfolio ; ● hire additional clinical , manufacturing and scientific personnel ; and ● add operational , financial and management information systems and personnel , including personnel to support our drug development efforts . 78 we believe that our cash , cash equivalents and investment balances as of december 31 , 2020 will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2022. however , we will need to secure additional funding in the future , from one or more equity or debt financings , government funding , collaborations , licensing transactions , other commercial transactions or other sources , in order to carry out all of our planned research and development activities with respect to ganaxolone . covid-19 in december 2019 , an outbreak of a novel strain of coronavirus ( covid-19 ) was identified in wuhan , china . this virus was declared a pandemic by the world health organization in march 2020 and has spread to nearly every country in the world , including the u.s. efforts to contain the spread of covid-19 have intensified and many countries , including the u.s. , have implemented severe travel restrictions , business shutdowns and social distancing measures that have impacted clinical development through supply chain shortages and clinical trial enrollment difficulties as hospitals reduce and redeploy staff , divert resources to patients suffering covid-19 and limit hospital access for non-patients . the pandemic poses the risk that we , our contractors , suppliers , or other partners may be prevented from conducting normal business activities for an indefinite period of time , including those due to shutdowns that may be requested or mandated by governmental authorities . the continued global spread of covid-19 has affected our operations but did not had a material impact on our business , operating results , financial condition or cash flows as of and for the year ended december 31 , 2020. for example , several of our phase 1 trials of oral ganaxolone to support the cdd indication have continued enrollment and are expected to be completed by the end of the second quarter of 2021 , despite experiencing delays in enrollment due to covid-19 . further , in response to covid-19 , for our ongoing clinical trials , we have implemented multiple measures consistent with guidance of the fda on the conduct of clinical trials of medical products during the covid-19 pandemic , including implementing remote site monitoring and remote visits using telemedicine where needed . however , covid-19 may still adversely impact our clinical trials . for example , our raise trial in rse is being conducted in hospitals , and resources related to the covid-19 pandemic may divert staffing in hospitals , taking resources away from our clinical trial . our ganaxolone clinical trials in the outpatient setting may be negatively impacted if patients and their caregivers do not want to participate in a clinical trial while the covid-19 pandemic continues to severely affect the world . story_separator_special_tag further , the continued spread of covid-19 has also led to severe disruption and volatility in the global capital markets , which could increase our cost of capital and adversely affect our ability to access the capital markets in the future . our failure to obtain sufficient funds on acceptable terms when needed could have a negative impact on our business , results of operations , and financial condition . our future capital requirements will depend on many factors , including : ● the effects of the covid-19 pandemic on our business , the medical community and the global economy ; ● the results of our preclinical studies and clinical trials ; ● the development , formulation and commercialization activities related to ganaxolone ; ● the scope , progress , results and costs of researching and developing ganaxolone or any other future product candidates , and conducting preclinical studies and clinical trials ; ● the timing of , and the costs involved in , obtaining regulatory approvals for ganaxolone or any other future product candidates ; ● the cost of commercialization activities if ganaxolone or any other future product candidates are approved for sale , including marketing , sales and distribution costs ; ● the cost of manufacturing and formulating ganaxolone , or any other future product candidates , to internal and regulatory standards for use in preclinical studies , clinical trials and , if approved , commercial sale ; ● our ability to establish and maintain strategic collaborations , licensing or other arrangements and the financial terms of such agreements ; ● our ability to receive funding under the barda contract ; ● any product liability , infringement or other lawsuits related to our product candidates and , if approved , products ; ● capital needed to attract and retain skilled personnel ; ● the costs involved in preparing , filing , prosecuting , maintaining , defending and enforcing patent claims , including litigation costs and the outcome of such litigation ; and ● the timing , receipt and amount of sales of , or royalties on , future approved products , if any . please see “ risk factors ” for additional risks associated with our substantial capital requirements . off-balance sheet arrangements we do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition , changes in financial condition , revenues or expenses , results of operations , liquidity , capital expenditures or capital resources that are material to investors . 84 discussion of critical accounting policies and significant judgments and estimates we base this management 's discussion and analysis of our financial condition and results of operations on our financial statements , which we have prepared in accordance with accounting principles generally accepted in the united states ( gaap ) . the preparation of our financial statements requires us to make estimates and judgments that affect the reported amounts of assets , liabilities , revenue and expenses and the disclosure of contingent assets and liabilities in our financial statements . we evaluate our estimates and judgments , including those related to accrued clinical trial expenses on an ongoing basis . we base our estimates on historical experience , known trends and events and various other factors that we believe to be reasonable under the circumstances , the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources . actual results may differ from these estimates under different assumptions or conditions . you should consider your evaluation of our financial condition and results of operations with these policies , judgments and estimates in mind . while we describe our significant accounting policies in the notes to our financial statements appearing elsewhere in this annual report on form 10-k , we believe the following accounting policies are the most critical to the judgments and estimates we use in the preparation of our financial statements . clinical trial expenses as part of the process of preparing our financial statements , we are required to estimate our clinical trial expenses . our clinical trial accrual process seeks to account for expenses resulting from our obligations under contracts with vendors , consultants and cros and clinical site agreements in connection with conducting clinical trials . the financial terms of these contracts are subject to negotiations , which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts . our objective is to reflect the appropriate clinical trial expenses in our financial statements by matching the appropriate expenses with the period in which services and efforts are expended . we account for these expenses according to the progress of the trial as measured by subject progression and the timing of various aspects of the trial . we determine accrual estimates based on estimates of the services received and efforts expended that take into account discussion with applicable personnel and outside service providers as to the progress or state of completion of trials . during the course of a clinical trial , we adjust our clinical expense recognition if actual results differ from our estimates . we make estimates of our accrued expenses and prepaid assets as of each balance sheet date in our financial statements based on the facts and circumstances known to us at that time . our clinical trial accrual and prepaid assets are dependent , in part , upon the receipt of timely and accurate reporting from cros and other third-party vendors . although we do not expect our estimates to differ materially from amounts we actually incur , our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high

