we have announced results of two phase 3 clinical trials for the prevention of cisplatin induced hearing loss , or ototoxicity in children including the pivotal phase 3 study siopel 6 , “ a multicentre open label randomised phase 3 trial of the efficacy of sodium thiosulfate in reducing ototoxicity in patients receiving cisplatin chemotherapy for standard risk hepatoblastoma , ” and the proof of concept phase 3 study “ a randomized phase 3 study of sodium thiosulfate for the prevention of cisplatin-induced ototoxicity in children ” . we have announced results of two phase 3 clinical trials for the prevention of cisplatin induced hearing loss , or ototoxicity in children including the pivotal phase 3 study siopel 6 , “ a multicentre open label randomised phase 3 trial of the efficacy of sodium thiosulfate in reducing ototoxicity in patients receiving cisplatin chemotherapy for standard risk hepatoblastoma , ” and the proof of concept phase 3 study “ a randomized phase 3 study of sodium thiosulfate for the prevention of cisplatin-induced ototoxicity in children ” . we continue to focus our resources on the development of pedmark tm . we have licensed from ohsu intellectual property rights for the use of pedmark tm as a chemoprotectant and are developing pedmark tm as a protectant against the hearing loss often caused by platinum-based anti-cancer agents in children . preclinical and clinical studies conducted by ohsu and others have indicated that pedmark tm can effectively reduce the incidence of hearing loss caused by platinum-based anti-cancer agents . hearing loss among children receiving platinum-based chemotherapy is frequent , permanent and often severely disabling . the incidence of hearing loss in these children depends upon the dose and duration of chemotherapy , and many of these children require lifelong hearing aids . in addition , adults undergoing chemotherapy for several common malignancies , including ovarian cancer , testicular cancer , and particularly head and neck cancer and brain cancer , often receive intensive platinum-based therapy and may experience severe , irreversible hearing loss , particularly in the high frequencies . we estimate in the u.s. and europe that annually over 10,000 children with solid tumors are treated with platinum agents . the vast majority of these newly diagnosed tumors are localized and classified as low to intermediate risk in nature . these localized cancers may have overall survival rates of greater than 80 % , further emphasizing the importance of quality of life after treatment . the incidence of hearing loss in these children depends upon the dose and duration of chemotherapy , and many of these children require lifelong hearing aids . there is currently no established preventive agent for this hearing loss and only expensive , technically difficult and sub-optimal cochlear ( inner ear ) implants have been shown to provide some benefit . infants and young children at critical stages of development lack speech language development and literacy , and older children and adolescents lack speech language development and literacy , and older children and adolescents lack social-emotional development and educational achievement . in march 2018 , pedmark tm received breakthrough therapy and fast track designations from the fda . further , pedmark tm has received orphan drug designation in the u.s. in this setting . we initiated our rolling new drug application ( “ nda ” ) for pedmark tm for the prevention of ototoxicity induced by cisplatin chemotherapy patients 1 month to < 18 years of age with localized , non-metastatic , solid tumors with the fda in december 2018. we announced that we had submitted full completion of the nda in february 2020. on april 13 , 2020 , we announced that the fda had accepted for filing and granted priority review for our nda . the fda set a prescription drug fee act ( “ pdufa ” ) target action date of august 10 , 2020 for the completion of the fda 's review . on august 10 , 2020 , we announced that we received a crl from the fda regarding our nda for pedmark tm , which identified deficiencies in the third-party manufacturing facility that manufactures pedmark tm on our behalf . importantly , no clinical safety or efficacy issues were identified during the review and there is no requirement for further clinical data . in the fourth quarter of 2020 , we engaged in a type a meeting with the fda concerning the crl that we believe was constructive and collaborative . we are working closely with our third-party drug manufacturer and the fda to fully address the crl , and we plan to resubmit our nda for pedmark tm in the second quarter of 2021 . 47 in august 2018 , the pediatric committee ( “ pdco ” ) of the european medicines agency ( “ ema ” ) accepted our pediatric investigation plan ( pip ) for sodium thiosulfate with the trade name pedmarqsi for the condition of the prevention of platinum-induced hearing loss . an accepted pip is a prerequisite for filing a marketing authorization application ( “ maa ” ) for any new medicinal product in europe . the indication targeted by our pip is for the prevention of platinum-induced ototoxic hearing loss for standard risk hepatoblastoma ( sr-hb ) . additional tumor types of the proposed indication will be subject to the committee for medicinal products for human use ( “ chmp ” ) assessment at the time of the maa . no deferred clinical studies were required in the positive opinion given by pdco . we were also advised that sodium thiosulfate ( tradename to be determined ) is eligible for submission of an application for a pediatric use marketing authorization ( “ puma ” ) . story_separator_special_tag 48 results of operations fiscal 2020 versus fiscal 2019 replace_table_token_2_th · revenues reported represent royalties related to elion deal with processa pharmaceuticals , inc. fennec received $ 0.005 million in cash and 41,250 in restricted shares of processa pharmaceuticals , inc. · research and development expense decreased by $ 0.5 million in fiscal 2020 as compared to fiscal 2019 , primarily due to the shift from research and development to pre-commercialization efforts for pedmark tm which took place in the first nine months of 2020 . · the $ 5.5 million increase in general and administrative expenses is attributed to the increase in pre-commercialization expenses . further there was a small rise in compensation to officers , directors and key contract employees in fiscal 2020 as compared to fiscal 2019 . · amortization expense relates to the bridge bank loan facility as the loan origination fees were capitalized in fiscal 2019 and 2020. after receiving the crl from the fda in august 2020 , management decided to amortize the remaining amounts associated with the loan facility . the facility expired on december 31 , 2020 . · interest income decreased in fiscal 2020 as compared to 2019 , due to lower interest rates on money market accounts for the comparable periods . · there was an unrealized gain of $ 0.1 million on the processa shares between the date acquired , october 30 , 2020 , and december 31 , 2020. going forward , the processa shares will be marked to market at each balance sheet date . the resulting change in value will result in an unrealized gain or loss . quarterly information the following table presents selected consolidated financial data for each of the last eight quarters through december 31 , 2020 , as prepared under generally accepted accounting principles within the united states , or u.s. gaap ( dollars in thousands , except per share information ) . replace_table_token_3_th quarter ended december 31 , 2020 versus 2019 replace_table_token_4_th 49 revenues reported represent royalties related to elion deal with processa pharmaceuticals , inc. fennec received $ 0.005 million in cash and 41,250 in restricted shares of processa pharmaceuticals , inc. we reported a loss from operations of $ 3.3 million for the three months ended december 31 , 2020 , compared to a loss from operations of $ 3.7 million for the same period in 2019. research and development expenses totaled $ 1.2 million for the three months ended december 31 , 2020 , which was the same for the same period in 2019. general and administrative expenses decreased by $ 0.2 million in the three months ended december 31 , 2020 , as compared to the same period in 2019. the decrease arises from our reduced pre-commercialization activities for pedmark tm as we focus on preparing to resubmit our nda application to the fda . there was an unrealized gain of $ 0.1 million on the processa shares between the date acquired , october 30 , 2020 , and december 31 , 2020. going forward , the processa shares will be marked to market at each balance sheet date . the resulting change in value will result in an unrealized gain or loss . replace_table_token_5_th story_separator_special_tag margin : 0pt 0 `` > none . critical accounting policies and estimates the preparation of financial statements in conformity with u.s. gaap requires management to make estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expense during the reporting period . these estimates are based on assumptions and judgments that may be affected by commercial , economic and other factors . actual results could differ from these estimates . an accounting policy is considered to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made , and if different estimates reasonably could have been used , or changes in the accounting estimates that are reasonably likely to occur periodically , could materially impact the financial statements . the following description of critical accounting policies , judgments and estimates should be read in conjunction with our december 31 , 2020 consolidated financial statements . stock-based compensation the calculation of the fair values of our stock-based compensation plans requires estimates that require management 's judgments . under asc 718 , the fair value of each stock option is estimated on the grant date using the black-scholes option-pricing model . the valuation models require assumptions and estimates to determine expected volatility , expected life , expected dividends and expected risk-free interest rates . the expected volatility was determined using historical volatility of our stock based on the contractual life of the award . the risk-free interest rate assumption was based on the yield on zero-coupon u.s. treasury strips at the award grant date . we also used historical data to estimate forfeiture experience . in valuing options granted in the fiscal years ended december 31 , 2020 and 2019 , we used the following weighted average assumptions : 51 replace_table_token_7_th common shares and warrants common shares are recorded as the net proceeds received on issuance after deducting all share issuance costs and the relative fair value of investor warrants . warrants are recorded at relative fair value and are deducted from the proceeds of common shares and recorded on the consolidated statements of shareholders ' equity as additional paid-in capital . outstanding share information our outstanding comparative share data at december 31 , 2020 and december 31 , 2019 is as follows ( in thousands ) : replace_table_token_8_th newly adopted and recent accounting pronouncements in august 2018 , the fasb issued asu 2018-13 , fair value measurement ( topic 820 ) : disclosure framework-changes to the disclosure requirements for fair value measurement . asu 2018-13 removes certain disclosures , modifies certain disclosures and

liquidity and capital resources · there was a $ 16.7 million increase in cash and cash equivalents between december 31 , 2020 and december 31 , 2019. the net increase was the result of our may 2020 public offering of common shares , which raised net proceeds of $ 32.0 million , as well as $ 0.5 million from various stock option exercises , offset by cash used for operating activities . during the period ended december 31 , 2020 , cash for operations was used mainly on the pre-commercialization activities of pedmark tm and regulatory submission activities relating to the nda . · the increase in other current assets between december 31 , 2020 and december 31 , 2019 primarily relates to the value of the processa shares and an increase in the prepaid amount for director and officer insurance premiums and costs associated with our at the market offering agreement , which was disclosed on october 20 , 2020 . · current liabilities at december 31 , 2020 increased $ 0.076 million compared to december 31 , 2019 primarily due to a minor rise in accounts payable associated with our commercialization and manufacturing activities for the production of pedmark tm and related regulatory expenses at year-end 2020 . · working capital increased between december 31 , 2020 and december 31 , 2019 by $ 17.5 million . the increase was a result of cash used in operations offset by $ 32.0 million from our may 2020 public offering of common shares , $ 0.5 million from stock option exercises and $ 0.1 million in interest income . cash outflows related to the regulatory and pre-commercial development activities of pedmark tm and general and administrative expenses .


 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 · there was a $ 16.7 million increase in cash and cash equivalents between december 31 , 2020 and december 31 , 2019. the net increase was the result of our may 2020 public offering of common shares , which raised net proceeds of $ 32.0 million , as well as $ 0.5 million from various stock option exercises , offset by cash used for operating activities . during the period ended december 31 , 2020 , cash for operations was used mainly on the pre-commercialization activities of pedmark tm and regulatory submission activities relating to the nda . · the increase in other current assets between december 31 , 2020 and december 31 , 2019 primarily relates to the value of the processa shares and an increase in the prepaid amount for director and officer insurance premiums and costs associated with our at the market offering agreement , which was disclosed on october 20 , 2020 . · current liabilities at december 31 , 2020 increased $ 0.076 million compared to december 31 , 2019 primarily due to a minor rise in accounts payable associated with our commercialization and manufacturing activities for the production of pedmark tm and related regulatory expenses at year-end 2020 . · working capital increased between december 31 , 2020 and december 31 , 2019 by $ 17.5 million . the increase was a result of cash used in operations offset by $ 32.0 million from our may 2020 public offering of common shares , $ 0.5 million from stock option exercises and $ 0.1 million in interest income . cash outflows related to the regulatory and pre-commercial development activities of pedmark tm and general and administrative expenses .
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 Suspicious Activity Report : we have announced results of two phase 3 clinical trials for the prevention of cisplatin induced hearing loss , or ototoxicity in children including the pivotal phase 3 study siopel 6 , “ a multicentre open label randomised phase 3 trial of the efficacy of sodium thiosulfate in reducing ototoxicity in patients receiving cisplatin chemotherapy for standard risk hepatoblastoma , ” and the proof of concept phase 3 study “ a randomized phase 3 study of sodium thiosulfate for the prevention of cisplatin-induced ototoxicity in children ” . we have announced results of two phase 3 clinical trials for the prevention of cisplatin induced hearing loss , or ototoxicity in children including the pivotal phase 3 study siopel 6 , “ a multicentre open label randomised phase 3 trial of the efficacy of sodium thiosulfate in reducing ototoxicity in patients receiving cisplatin chemotherapy for standard risk hepatoblastoma , ” and the proof of concept phase 3 study “ a randomized phase 3 study of sodium thiosulfate for the prevention of cisplatin-induced ototoxicity in children ” . we continue to focus our resources on the development of pedmark tm . we have licensed from ohsu intellectual property rights for the use of pedmark tm as a chemoprotectant and are developing pedmark tm as a protectant against the hearing loss often caused by platinum-based anti-cancer agents in children . preclinical and clinical studies conducted by ohsu and others have indicated that pedmark tm can effectively reduce the incidence of hearing loss caused by platinum-based anti-cancer agents . hearing loss among children receiving platinum-based chemotherapy is frequent , permanent and often severely disabling . the incidence of hearing loss in these children depends upon the dose and duration of chemotherapy , and many of these children require lifelong hearing aids . in addition , adults undergoing chemotherapy for several common malignancies , including ovarian cancer , testicular cancer , and particularly head and neck cancer and brain cancer , often receive intensive platinum-based therapy and may experience severe , irreversible hearing loss , particularly in the high frequencies . we estimate in the u.s. and europe that annually over 10,000 children with solid tumors are treated with platinum agents . the vast majority of these newly diagnosed tumors are localized and classified as low to intermediate risk in nature . these localized cancers may have overall survival rates of greater than 80 % , further emphasizing the importance of quality of life after treatment . the incidence of hearing loss in these children depends upon the dose and duration of chemotherapy , and many of these children require lifelong hearing aids . there is currently no established preventive agent for this hearing loss and only expensive , technically difficult and sub-optimal cochlear ( inner ear ) implants have been shown to provide some benefit . infants and young children at critical stages of development lack speech language development and literacy , and older children and adolescents lack speech language development and literacy , and older children and adolescents lack social-emotional development and educational achievement . in march 2018 , pedmark tm received breakthrough therapy and fast track designations from the fda . further , pedmark tm has received orphan drug designation in the u.s. in this setting . we initiated our rolling new drug application ( “ nda ” ) for pedmark tm for the prevention of ototoxicity induced by cisplatin chemotherapy patients 1 month to < 18 years of age with localized , non-metastatic , solid tumors with the fda in december 2018. we announced that we had submitted full completion of the nda in february 2020. on april 13 , 2020 , we announced that the fda had accepted for filing and granted priority review for our nda . the fda set a prescription drug fee act ( “ pdufa ” ) target action date of august 10 , 2020 for the completion of the fda 's review . on august 10 , 2020 , we announced that we received a crl from the fda regarding our nda for pedmark tm , which identified deficiencies in the third-party manufacturing facility that manufactures pedmark tm on our behalf . importantly , no clinical safety or efficacy issues were identified during the review and there is no requirement for further clinical data . in the fourth quarter of 2020 , we engaged in a type a meeting with the fda concerning the crl that we believe was constructive and collaborative . we are working closely with our third-party drug manufacturer and the fda to fully address the crl , and we plan to resubmit our nda for pedmark tm in the second quarter of 2021 . 47 in august 2018 , the pediatric committee ( “ pdco ” ) of the european medicines agency ( “ ema ” ) accepted our pediatric investigation plan ( pip ) for sodium thiosulfate with the trade name pedmarqsi for the condition of the prevention of platinum-induced hearing loss . an accepted pip is a prerequisite for filing a marketing authorization application ( “ maa ” ) for any new medicinal product in europe . the indication targeted by our pip is for the prevention of platinum-induced ototoxic hearing loss for standard risk hepatoblastoma ( sr-hb ) . additional tumor types of the proposed indication will be subject to the committee for medicinal products for human use ( “ chmp ” ) assessment at the time of the maa . no deferred clinical studies were required in the positive opinion given by pdco . we were also advised that sodium thiosulfate ( tradename to be determined ) is eligible for submission of an application for a pediatric use marketing authorization ( “ puma ” ) . story_separator_special_tag 48 results of operations fiscal 2020 versus fiscal 2019 replace_table_token_2_th · revenues reported represent royalties related to elion deal with processa pharmaceuticals , inc. fennec received $ 0.005 million in cash and 41,250 in restricted shares of processa pharmaceuticals , inc. · research and development expense decreased by $ 0.5 million in fiscal 2020 as compared to fiscal 2019 , primarily due to the shift from research and development to pre-commercialization efforts for pedmark tm which took place in the first nine months of 2020 . · the $ 5.5 million increase in general and administrative expenses is attributed to the increase in pre-commercialization expenses . further there was a small rise in compensation to officers , directors and key contract employees in fiscal 2020 as compared to fiscal 2019 . · amortization expense relates to the bridge bank loan facility as the loan origination fees were capitalized in fiscal 2019 and 2020. after receiving the crl from the fda in august 2020 , management decided to amortize the remaining amounts associated with the loan facility . the facility expired on december 31 , 2020 . · interest income decreased in fiscal 2020 as compared to 2019 , due to lower interest rates on money market accounts for the comparable periods . · there was an unrealized gain of $ 0.1 million on the processa shares between the date acquired , october 30 , 2020 , and december 31 , 2020. going forward , the processa shares will be marked to market at each balance sheet date . the resulting change in value will result in an unrealized gain or loss . quarterly information the following table presents selected consolidated financial data for each of the last eight quarters through december 31 , 2020 , as prepared under generally accepted accounting principles within the united states , or u.s. gaap ( dollars in thousands , except per share information ) . replace_table_token_3_th quarter ended december 31 , 2020 versus 2019 replace_table_token_4_th 49 revenues reported represent royalties related to elion deal with processa pharmaceuticals , inc. fennec received $ 0.005 million in cash and 41,250 in restricted shares of processa pharmaceuticals , inc. we reported a loss from operations of $ 3.3 million for the three months ended december 31 , 2020 , compared to a loss from operations of $ 3.7 million for the same period in 2019. research and development expenses totaled $ 1.2 million for the three months ended december 31 , 2020 , which was the same for the same period in 2019. general and administrative expenses decreased by $ 0.2 million in the three months ended december 31 , 2020 , as compared to the same period in 2019. the decrease arises from our reduced pre-commercialization activities for pedmark tm as we focus on preparing to resubmit our nda application to the fda . there was an unrealized gain of $ 0.1 million on the processa shares between the date acquired , october 30 , 2020 , and december 31 , 2020. going forward , the processa shares will be marked to market at each balance sheet date . the resulting change in value will result in an unrealized gain or loss . replace_table_token_5_th story_separator_special_tag margin : 0pt 0 `` > none . critical accounting policies and estimates the preparation of financial statements in conformity with u.s. gaap requires management to make estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expense during the reporting period . these estimates are based on assumptions and judgments that may be affected by commercial , economic and other factors . actual results could differ from these estimates . an accounting policy is considered to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made , and if different estimates reasonably could have been used , or changes in the accounting estimates that are reasonably likely to occur periodically , could materially impact the financial statements . the following description of critical accounting policies , judgments and estimates should be read in conjunction with our december 31 , 2020 consolidated financial statements . stock-based compensation the calculation of the fair values of our stock-based compensation plans requires estimates that require management 's judgments . under asc 718 , the fair value of each stock option is estimated on the grant date using the black-scholes option-pricing model . the valuation models require assumptions and estimates to determine expected volatility , expected life , expected dividends and expected risk-free interest rates . the expected volatility was determined using historical volatility of our stock based on the contractual life of the award . the risk-free interest rate assumption was based on the yield on zero-coupon u.s. treasury strips at the award grant date . we also used historical data to estimate forfeiture experience . in valuing options granted in the fiscal years ended december 31 , 2020 and 2019 , we used the following weighted average assumptions : 51 replace_table_token_7_th common shares and warrants common shares are recorded as the net proceeds received on issuance after deducting all share issuance costs and the relative fair value of investor warrants . warrants are recorded at relative fair value and are deducted from the proceeds of common shares and recorded on the consolidated statements of shareholders ' equity as additional paid-in capital . outstanding share information our outstanding comparative share data at december 31 , 2020 and december 31 , 2019 is as follows ( in thousands ) : replace_table_token_8_th newly adopted and recent accounting pronouncements in august 2018 , the fasb issued asu 2018-13 , fair value measurement ( topic 820 ) : disclosure framework-changes to the disclosure requirements for fair value measurement . asu 2018-13 removes certain disclosures , modifies certain disclosures and

