study 404 also met its key secondary endpoint , clinical global impression scale for bipolar for severity of illness ( cgi-bp-s ) total score ( p < 0.001 ; effect size = 0.46 ) . study 401 tested two doses of lumateperone , 42 mg and 28mg along with placebo . in this trial , neither dose of lumateperone met the primary endpoint of statistical separation from placebo as measured by change 58 from baseline on the madrs total score . there was a high placebo response in this trial . lumateperone was generally well-tolerated in all three bipolar depression studies , with a favorable safety profile . in addition , while our phase 3 bipolar depression trials were powered for the overall patient population and not powered for subpopulation analyses , statistically significant benefit versus placebo was seen in the subgroup of patients with bipolar i and bipolar ii disorder in study 404 and in patients with bipolar i disorder in study 402 , but the bipolar ii subgroup was not statistically significant in study 402. in february 2021 , we submitted supplemental new drug applications , or sndas , to the fda for potential regulatory approval of lumateperone for the treatment of bipolar depression in patients with bipolar i or ii disorder as monotherapy and adjunctive therapy . assuming the snda submissions are accepted by the fda , we anticipate an fda target action date for the sndas in the second half of 2021. we are also pursuing clinical development of lumateperone for the treatment of additional cns diseases and disorders . at a dose of 42 mg , lumateperone has been shown effective in treating the symptoms associated with schizophrenia , and we believe lumateperone may represent a potential treatment for mood disorders including mdd , post-traumatic stress disorder and intermittent explosive disorder . we have commenced our program of lumateperone in mdd evaluating lumateperone as an adjunctive therapy to antidepressants for the treatment of mdd and we expect to initiate clinical conduct in two phase 3 trials in 2021. within the lumateperone portfolio , we are also developing a long-acting injectable formulation to provide more treatment options to patients suffering from mental illness . we have completed the preclinical development of a long-acting injectable formulation and in december 2020 we initiated a phase 1 single ascending dose study of lumateperone lai , a formulation of lumateperone designed to be administered subcutaneously and to maintain therapeutic levels of lumateperone for at least one month . this study will evaluate the pharmacokinetics , safety and tolerability of lumateperone lai in patients with stable symptoms of schizophrenia . we anticipate topline results from this study will be available in the second half of 2021. results from this study will inform the dosing strategy for future studies . given the encouraging tolerability data to date with oral lumateperone , we believe that a long-acting injectable option , in particular , may lend itself to being an important formulation choice for certain patients . we hold exclusive , worldwide commercialization rights to lumateperone and a family of compounds from bristol-myers squibb company pursuant to an exclusive license . we are developing iti-1284 for the treatment of behavioral disturbances in patients with dementia , the treatment of dementia-related psychosis and for the treatment of certain depressive disorders in the elderly . iti-1284 is a deuterated form of lumateperone , a new molecular entity formulated as an oral disintegrating tabl et for sublingual administration . iti-1284 is formulated as an oral solid dosage form that dissolves almost instantly when placed under the tongue , allowing for ease of use in the elderly and may be particularly beneficial for patients who have difficulty swallowing conventional tablets . phase 1 single and multiple ascending dose studies in healthy volunteers and healthy elderly volunteers ( > than 65 years of age ) evaluated the safety , tolerability and pharmacokinetics of iti-1284 . in these studies , there were no reported serious adverse events in either age group . in the elderly cohort , reported adverse events were infrequent with the most common adverse event being transient dry mouth ( mild ) . based on these studies , we plan to initiate phase 2 studies evaluating iti-1284 for the treatment of behavioral disturbances in dementia , dementia-related psychosis , and certain depressive disorders in the elderly . we have another major program called iti-002 that has yielded a portfolio of compounds that selectively inhibit the enzyme phosphodiesterase type 1 , or pde1 . pde1 enzymes are highly active in multiple disease states and our pde1 inhibitors are designed to reestablish normal function in these disease states . abnormal pde1 activity is associated with cellular proliferation and activation of inflammatory cells . our pde1 inhibitors ameliorate both of these effects in animal models . we intend to pursue the development of our phosphodiesterase , or pde , program , for the treatment aberrant immune system activation in several cns and non-cns conditions with a focus on diseases where excessive pde1 activity has been demonstrated and increased inflammation is an important contributor to disease pathogenesis . our potential disease targets include 59 heart failure , immune system regulation , neurodegenerative diseases , cancers and other non-cns disorders . iti-214 is our lead compound in this program . we believe iti-214 is the first compound in its class to successfully advance into phase 1 clinical trials . following the favorable safety and tolerability results in our phase 1 program , we initiated our development program for iti-214 for parkinson 's disease and commenced patient enrollment in the third quarter of 2017 in a phase 1/2 clinical trial of iti-214 in patients with parkinson 's disease to evaluate safety and tolerability in this patient population , as well as motor and non-motor exploratory endpoints . story_separator_special_tag cost of product sales cost of product sales was approximately $ 1.9 million for the year ended december 31 , 2020. cost of product sales consisted primarily of product royalty fees , overhead and minimal direct costs . product sold during the year ended december 31 , 2020 generally consisted of drug product that was previously charged to research and development expense prior to fda approval of caplyta . this minimal cost drug product had a positive impact on our cost of product sales and related product gross margins for the year ended december 31 , 2020. no similar cost of product sales was recognized during the year ended december 31 , 2019. we will continue to have a lower cost of product sales that excludes the cost of the drug product that was incurred prior to fda approval until our sales of caplyta include drug product that is manufactured after the fda approval . we expect that this will be the case for the near-term and as a result , our cost of product sales will be less than we anticipate it will be in future periods . research and development expenses replace_table_token_2_th 64 replace_table_token_3_th research and development expenses decreased to $ 65.8 million for the year ended december 31 , 2020 as compared to $ 89.1 million for the year ended december 31 , 2019 , representing a decrease of approximately $ 23.3 million , or 26 % . this decrease is due primarily to a decrease of approximately $ 15.1 million in manufacturing expense , which is due to expensing manufacturing costs related to caplyta prior to fda approval in prior years and capitalizing a significant portion as inventory in the current year , a decrease of approximately $ 4.2 million of lumateperone clinical and non-clinical expenses , a decrease of approximately $ 3.0 million relating to other projects and overhead , and a decrease of approximately $ 1.0 million of share-based compensation expense . internal costs decreased by approximately $ 3.0 million for the period due to lower labor related expenses , stock compensation expense , travel and other operating costs . as development of lumateperone progresses , we anticipate costs for lumateperone to increase due primarily to ongoing and planned clinical trials relating to our lumateperone programs in the next several years as we conduct phase 3 and other clinical trials . we are also required to complete non-clinical testing to obtain fda approval and manufacture material needed for clinical trial use , which includes non-clinical testing of the drug product and the creation of an inventory of drug product in anticipation of possible fda approval . we received fda approval on december 20 , 2019 for caplyta ( lumateperone ) for the treatment for schizophrenia in adults . there was no lumateperone inventory purchased , received , or produced from the date of approval through december 31 , 2019 and therefore no inventory costs are reflected on our balance sheet through december 31 , 2019. as of december 31 , 2020 , we employed 43 full time personnel in our research and development group as compared to 56 full time personnel in our research and development group at december 31 , 2019. the decrease is due primarily to personnel transitioning from research-related activities to commercial efforts in 2020. we expect to hire additional staff as we increase our development efforts and grow our business in the upcoming years . we currently have several projects , in addition to lumateperone , that are in the research and development stages , including in the areas of cognitive dysfunction and the treatment of neurodegenerative diseases , including ad , among others . we have used internal resources and incurred expenses not only in relation to the development of lumateperone , but also in connection with these additional projects as well , including our pde program . we have not , however , reported these costs on a project by project basis , as these costs are broadly spread among these projects . the external costs for these projects have been modest and are reflected in the amounts discussed in this section “ —research and development expenses . ” the research and development process necessary to develop a pharmaceutical product for commercialization is subject to extensive regulation by numerous governmental authorities in the united states and other countries . this process typically takes years to complete and requires the expenditure of substantial resources . the steps required before a drug may be marketed in the united states generally include the following : completion of extensive pre-clinical laboratory tests , animal studies , and formulation studies in accordance with the fda 's good laboratory practice , or glp , regulations ; submission to the fda of an investigational new drug application , or ind , for human clinical testing , which must become effective before human clinical trials may begin ; 65 performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug for each proposed indication ; submission to the fda of a new drug application , or nda , after completion of all clinical trials ; satisfactory completion of an fda pre-approval inspection of the manufacturing facility or facilities at which the active pharmaceutical ingredient , or api , and finished drug product are produced and tested to assess compliance with current good manufacturing practices , or cgmps ; satisfactory completion of fda inspections of clinical trial sites to assure that data supporting the safety and effectiveness of product candidates has been generated in compliance with good clinical practices ; and fda review and approval of the nda prior to any commercial marketing or sale of the drug in the united states . the successful development of our product candidates and the approval process requires substantial time , effort and financial resources , and is uncertain and subject to a number of risks . we can not be certain that any

liquidity and capital resources through december 31 , 2020 , we provided funds for our operations by obtaining a total of approximately $ 1.6 billion of cash primarily through public and private offerings of our common stock and other securities , grants from government agencies and foundations and payments received under a terminated license and collaboration agreement . in the year ended december 31 , 2020 , we have collected approximately $ 16.8 million from product sales , which we believe will increase going forward . we do not believe that grant revenue will be a significant source of funding in the near future . on january 10 , 2020 , we completed a public offering of 10,000,000 shares of our common stock . all of the shares in the offering were sold by the company , with gross proceeds to the company of $ 295.0 million and net proceeds of approximately $ 277.0 million , after deducting underwriting discounts , commissions and offering expenses . in june 2020 , we sold 230,000 shares of common stock under our at-the-market equity program generating $ 5.6 million in net proceeds which was received in july 2020. in the third quarter of 2020 , we sold an additional 512,791 shares of common stock utilizing our at-the-market program and received $ 12.3 million of net proceeds . in september 2020 we completed a public offering of common stock in which we sold 12,666,667 shares of common stock at a public offering price of $ 30.00 per share for aggregate gross proceeds of $ 380.0 million . after deducting underwriting discounts , commissions and offering expenses , the net proceeds to the company were approximately $ 357.8 million .


 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.
     ```liquidity and capital resources through december 31 , 2020 , we provided funds for our operations by obtaining a total of approximately $ 1.6 billion of cash primarily through public and private offerings of our common stock and other securities , grants from government agencies and foundations and payments received under a terminated license and collaboration agreement . in the year ended december 31 , 2020 , we have collected approximately $ 16.8 million from product sales , which we believe will increase going forward . we do not believe that grant revenue will be a significant source of funding in the near future . on january 10 , 2020 , we completed a public offering of 10,000,000 shares of our common stock . all of the shares in the offering were sold by the company , with gross proceeds to the company of $ 295.0 million and net proceeds of approximately $ 277.0 million , after deducting underwriting discounts , commissions and offering expenses . in june 2020 , we sold 230,000 shares of common stock under our at-the-market equity program generating $ 5.6 million in net proceeds which was received in july 2020. in the third quarter of 2020 , we sold an additional 512,791 shares of common stock utilizing our at-the-market program and received $ 12.3 million of net proceeds . in september 2020 we completed a public offering of common stock in which we sold 12,666,667 shares of common stock at a public offering price of $ 30.00 per share for aggregate gross proceeds of $ 380.0 million . after deducting underwriting discounts , commissions and offering expenses , the net proceeds to the company were approximately $ 357.8 million .
```    
 Suspicious Activity Report : study 404 also met its key secondary endpoint , clinical global impression scale for bipolar for severity of illness ( cgi-bp-s ) total score ( p < 0.001 ; effect size = 0.46 ) . study 401 tested two doses of lumateperone , 42 mg and 28mg along with placebo . in this trial , neither dose of lumateperone met the primary endpoint of statistical separation from placebo as measured by change 58 from baseline on the madrs total score . there was a high placebo response in this trial . lumateperone was generally well-tolerated in all three bipolar depression studies , with a favorable safety profile . in addition , while our phase 3 bipolar depression trials were powered for the overall patient population and not powered for subpopulation analyses , statistically significant benefit versus placebo was seen in the subgroup of patients with bipolar i and bipolar ii disorder in study 404 and in patients with bipolar i disorder in study 402 , but the bipolar ii subgroup was not statistically significant in study 402. in february 2021 , we submitted supplemental new drug applications , or sndas , to the fda for potential regulatory approval of lumateperone for the treatment of bipolar depression in patients with bipolar i or ii disorder as monotherapy and adjunctive therapy . assuming the snda submissions are accepted by the fda , we anticipate an fda target action date for the sndas in the second half of 2021. we are also pursuing clinical development of lumateperone for the treatment of additional cns diseases and disorders . at a dose of 42 mg , lumateperone has been shown effective in treating the symptoms associated with schizophrenia , and we believe lumateperone may represent a potential treatment for mood disorders including mdd , post-traumatic stress disorder and intermittent explosive disorder . we have commenced our program of lumateperone in mdd evaluating lumateperone as an adjunctive therapy to antidepressants for the treatment of mdd and we expect to initiate clinical conduct in two phase 3 trials in 2021. within the lumateperone portfolio , we are also developing a long-acting injectable formulation to provide more treatment options to patients suffering from mental illness . we have completed the preclinical development of a long-acting injectable formulation and in december 2020 we initiated a phase 1 single ascending dose study of lumateperone lai , a formulation of lumateperone designed to be administered subcutaneously and to maintain therapeutic levels of lumateperone for at least one month . this study will evaluate the pharmacokinetics , safety and tolerability of lumateperone lai in patients with stable symptoms of schizophrenia . we anticipate topline results from this study will be available in the second half of 2021. results from this study will inform the dosing strategy for future studies . given the encouraging tolerability data to date with oral lumateperone , we believe that a long-acting injectable option , in particular , may lend itself to being an important formulation choice for certain patients . we hold exclusive , worldwide commercialization rights to lumateperone and a family of compounds from bristol-myers squibb company pursuant to an exclusive license . we are developing iti-1284 for the treatment of behavioral disturbances in patients with dementia , the treatment of dementia-related psychosis and for the treatment of certain depressive disorders in the elderly . iti-1284 is a deuterated form of lumateperone , a new molecular entity formulated as an oral disintegrating tabl et for sublingual administration . iti-1284 is formulated as an oral solid dosage form that dissolves almost instantly when placed under the tongue , allowing for ease of use in the elderly and may be particularly beneficial for patients who have difficulty swallowing conventional tablets . phase 1 single and multiple ascending dose studies in healthy volunteers and healthy elderly volunteers ( > than 65 years of age ) evaluated the safety , tolerability and pharmacokinetics of iti-1284 . in these studies , there were no reported serious adverse events in either age group . in the elderly cohort , reported adverse events were infrequent with the most common adverse event being transient dry mouth ( mild ) . based on these studies , we plan to initiate phase 2 studies evaluating iti-1284 for the treatment of behavioral disturbances in dementia , dementia-related psychosis , and certain depressive disorders in the elderly . we have another major program called iti-002 that has yielded a portfolio of compounds that selectively inhibit the enzyme phosphodiesterase type 1 , or pde1 . pde1 enzymes are highly active in multiple disease states and our pde1 inhibitors are designed to reestablish normal function in these disease states . abnormal pde1 activity is associated with cellular proliferation and activation of inflammatory cells . our pde1 inhibitors ameliorate both of these effects in animal models . we intend to pursue the development of our phosphodiesterase , or pde , program , for the treatment aberrant immune system activation in several cns and non-cns conditions with a focus on diseases where excessive pde1 activity has been demonstrated and increased inflammation is an important contributor to disease pathogenesis . our potential disease targets include 59 heart failure , immune system regulation , neurodegenerative diseases , cancers and other non-cns disorders . iti-214 is our lead compound in this program . we believe iti-214 is the first compound in its class to successfully advance into phase 1 clinical trials . following the favorable safety and tolerability results in our phase 1 program , we initiated our development program for iti-214 for parkinson 's disease and commenced patient enrollment in the third quarter of 2017 in a phase 1/2 clinical trial of iti-214 in patients with parkinson 's disease to evaluate safety and tolerability in this patient population , as well as motor and non-motor exploratory endpoints . story_separator_special_tag cost of product sales cost of product sales was approximately $ 1.9 million for the year ended december 31 , 2020. cost of product sales consisted primarily of product royalty fees , overhead and minimal direct costs . product sold during the year ended december 31 , 2020 generally consisted of drug product that was previously charged to research and development expense prior to fda approval of caplyta . this minimal cost drug product had a positive impact on our cost of product sales and related product gross margins for the year ended december 31 , 2020. no similar cost of product sales was recognized during the year ended december 31 , 2019. we will continue to have a lower cost of product sales that excludes the cost of the drug product that was incurred prior to fda approval until our sales of caplyta include drug product that is manufactured after the fda approval . we expect that this will be the case for the near-term and as a result , our cost of product sales will be less than we anticipate it will be in future periods . research and development expenses replace_table_token_2_th 64 replace_table_token_3_th research and development expenses decreased to $ 65.8 million for the year ended december 31 , 2020 as compared to $ 89.1 million for the year ended december 31 , 2019 , representing a decrease of approximately $ 23.3 million , or 26 % . this decrease is due primarily to a decrease of approximately $ 15.1 million in manufacturing expense , which is due to expensing manufacturing costs related to caplyta prior to fda approval in prior years and capitalizing a significant portion as inventory in the current year , a decrease of approximately $ 4.2 million of lumateperone clinical and non-clinical expenses , a decrease of approximately $ 3.0 million relating to other projects and overhead , and a decrease of approximately $ 1.0 million of share-based compensation expense . internal costs decreased by approximately $ 3.0 million for the period due to lower labor related expenses , stock compensation expense , travel and other operating costs . as development of lumateperone progresses , we anticipate costs for lumateperone to increase due primarily to ongoing and planned clinical trials relating to our lumateperone programs in the next several years as we conduct phase 3 and other clinical trials . we are also required to complete non-clinical testing to obtain fda approval and manufacture material needed for clinical trial use , which includes non-clinical testing of the drug product and the creation of an inventory of drug product in anticipation of possible fda approval . we received fda approval on december 20 , 2019 for caplyta ( lumateperone ) for the treatment for schizophrenia in adults . there was no lumateperone inventory purchased , received , or produced from the date of approval through december 31 , 2019 and therefore no inventory costs are reflected on our balance sheet through december 31 , 2019. as of december 31 , 2020 , we employed 43 full time personnel in our research and development group as compared to 56 full time personnel in our research and development group at december 31 , 2019. the decrease is due primarily to personnel transitioning from research-related activities to commercial efforts in 2020. we expect to hire additional staff as we increase our development efforts and grow our business in the upcoming years . we currently have several projects , in addition to lumateperone , that are in the research and development stages , including in the areas of cognitive dysfunction and the treatment of neurodegenerative diseases , including ad , among others . we have used internal resources and incurred expenses not only in relation to the development of lumateperone , but also in connection with these additional projects as well , including our pde program . we have not , however , reported these costs on a project by project basis , as these costs are broadly spread among these projects . the external costs for these projects have been modest and are reflected in the amounts discussed in this section “ —research and development expenses . ” the research and development process necessary to develop a pharmaceutical product for commercialization is subject to extensive regulation by numerous governmental authorities in the united states and other countries . this process typically takes years to complete and requires the expenditure of substantial resources . the steps required before a drug may be marketed in the united states generally include the following : completion of extensive pre-clinical laboratory tests , animal studies , and formulation studies in accordance with the fda 's good laboratory practice , or glp , regulations ; submission to the fda of an investigational new drug application , or ind , for human clinical testing , which must become effective before human clinical trials may begin ; 65 performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug for each proposed indication ; submission to the fda of a new drug application , or nda , after completion of all clinical trials ; satisfactory completion of an fda pre-approval inspection of the manufacturing facility or facilities at which the active pharmaceutical ingredient , or api , and finished drug product are produced and tested to assess compliance with current good manufacturing practices , or cgmps ; satisfactory completion of fda inspections of clinical trial sites to assure that data supporting the safety and effectiveness of product candidates has been generated in compliance with good clinical practices ; and fda review and approval of the nda prior to any commercial marketing or sale of the drug in the united states . the successful development of our product candidates and the approval process requires substantial time , effort and financial resources , and is uncertain and subject to a number of risks . we can not be certain that any

