in the fourth quarter of 2014 , we filed an maa with the european medicines agency ( ema ) for arikayce as a treatment for ntm lung disease in adult patients and for cystic fibrosis ( cf ) patients with pseudomonas lung infections . the filing was based on data from our phase 3 study in cf patients with pseudomonas and our phase 2 study in patients with ntm . in february 2015 , the ema validated our maa as complete for review . the ema subsequently requested additional information with respect to the cf indication regarding the similarity of arikayce to another product that has an orphan designation for the same pseudomonas indication . in the third quarter of 2015 , the ema adopted our request to withdraw the pseudomonas indication from our maa . in april 2016 , we submitted our written responses to the ema 's 180-day list of outstanding issues ( loi ) . in may 2016 , we participated in an oral explanation meeting with the chmp for the ntm indication to address the loi . after the oral explanation meeting , the chmp concluded that the data submitted did not provide enough evidence to support an approval . in june 2016 , we withdrew our maa . we intend to seek marketing approval for arikayce in the eu , japan and certain other countries outside the us when sufficient data are available . ins1007 ins1007 is a novel oral reversible inhibitor of dipeptidyl peptidase 1 ( dpp1 ) , an enzyme responsible for activating neutrophil serine proteases , which are implicated in the pathology of chronic inflammatory lung diseases , such as non-cystic fibrosis ( non-cf ) bronchiectasis . in october 2016 , we acquired the exclusive global rights to ins1007 ( formerly known as azd7986 ) from astrazeneca and we are finalizing our plans for a phase 2 study in our lead indication , non-cf bronchiectasis . in a phase 1 study of healthy volunteers , azd7986 was well tolerated and demonstrated inhibition of the activity of the neutrophil serine protease neutrophil elastase in a dose and concentration dependent manner . in preclinical studies , ins1007 was shown to reversibly inhibit dpp1 and the activation of neutrophil serine proteases within maturing neutrophils . we are defining our regulatory strategies to potentially secure us and eu orphan drug designations and expedite the development and regulatory review of ins1007 through programs such as us fast track designation and breakthrough therapy . we plan to submit an investigational new drug ( ind ) application to the us food and drug administration ( fda ) for non-cf bronchiectasis and subsequently commence a phase 2 clinical study of ins1007 . the study is expected to begin in 2017. in addition , we are evaluating ins1007 in other potential indications . ins1009 ins1009 is our inhaled nanoparticle formulation of a treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders , including pulmonary arterial hypertension ( pah ) . we have completed a phase 1 study of ins1009 in healthy subjects and the results were presented at the european respiratory society international congress in september 2016. this first-in-human study of ins1009 determined the maximum-tolerated dose of a single dose of ins1009 and characterized a pharmacokinetic profile that supports once- or twice-daily dosing . the longer 68 half-life of treprostinil associated with ins1009 was likely due to a sustained pulmonary release . we are currently evaluating our options to advance its development . other development activities our earlier-stage pipeline includes preclinical compounds that we are evaluating in multiple rare diseases of unmet medical need , including methicillin-resistant staph aureus ( mrsa ) and ntm . to complement our internal research and development , we actively evaluate in-licensing and acquisition opportunities for a broad range of rare diseases . key components of our results of operations research and development expenses research and development expenses consist primarily of salaries , benefits and other related costs , including stock-based compensation , for personnel serving in our research and development functions . expenses also include other internal operating expenses , the cost of manufacturing our drug candidate for clinical study , the cost of conducting clinical studies , and the cost of conducting preclinical and research activities . in addition , our research and development expenses include payments to third parties for the license rights to products in development ( prior to marketing approval ) , such as for ins1007 . our expenses related to manufacturing our drug candidate for clinical study are primarily related to activities at contract manufacturing organizations ( cmos ) that manufacture arikayce for our use . our expenses related to clinical trials are primarily related to activities at contract research organizations that conduct and manage clinical trials on our behalf . since 2011 , we have focused our development activities principally on our proprietary , advanced liposomal technology designed specifically for inhalation lung delivery . in 2015 , we commenced the convert study for arikayce for adult patients with treatment refractory ntm lung disease . in 2015 , we also completed an open-label extension study in which cf patients that completed our phase 3 trial received arikayce for a period of two years . the majority of our research and development expenses have been for our arikayce development programs . our development efforts in 2016 principally related to the development of arikayce in the ntm lung disease indication described above . general and administrative expenses general and administrative expenses consist primarily of salaries , benefits and other related costs , including stock-based compensation , for our non-management directors and personnel serving in our executive , finance and accounting , legal , pre-commercial , corporate development , information technology , program management and human resource functions . general and administrative expenses also include professional fees for legal , including patent-related expenses , consulting , insurance , board of director fees , tax and accounting services . story_separator_special_tag the az license agreement provides astrazeneca with the option to negotiate a future agreement with us for commercialization of ins1007 in chronic obstructive pulmonary disease or asthma . future funding requirements to date , we have not generated material revenue from arikayce , and we do not know when , or if , we will generate such revenue . we do not expect to generate such revenue unless or until we obtain marketing approval of , secure reimbursement for , and commercialize , arikayce . we will need to raise additional capital to fund our operations , to develop and commercialize arikayce , to develop ins1007 and ins1009 , and to develop , acquire , in-license or co-promote other products that address orphan or rare diseases . our future capital requirements may be substantial and will depend on many factors , including : · the timing and cost of our anticipated clinical trials of arikayce for the treatment of patients with ntm lung infections ; · the decisions of the fda and ema with respect to our applications for marketing approval of arikayce in the us and europe ; the costs of activities related to the regulatory approval process ; and the timing of approvals , if received ; · the cost of putting in place the sales and marketing capabilities necessary to be prepared for a potential commercial launch of arikayce , if approved ; · the cost of filing , prosecuting , defending , and enforcing patent claims ; · the timing and cost of our anticipated clinical trials , including ins1007 and the related milestone payments due to astrazeneca ; 78 · the costs of our manufacturing-related activities ; · the costs associated with commercializing arikayce , if we receive marketing approval ; and · subject to receipt of marketing approval , the levels , timing and collection of revenue received from sales of approved products , if any , in the future . in april 2015 , we generated net proceeds of $ 222.9 million from the issuance of 11.5 million shares of common stock . on september 30 , 2016 , the total committed amount under the a & r loan agreement with hercules was increased to $ 55.0 million , $ 25.0 million of which was previously outstanding . during the fourth quarter of 2016 , we drew down the remaining commitment . we believe we currently have sufficient funds to meet our financial needs for the next 12 months . however , our business strategy will require us to raise additional capital at any time through equity or debt financing ( s ) , strategic transactions or otherwise . such additional funding will be necessary to continue to develop our potential product candidates , to pursue the license or purchase of complementary technologies , to commercialize our product candidates or to purchase other products . if we are unable to obtain additional financing , we may be required to reduce the scope of our planned product development and commercialization or our plans to establish a sales and marketing force , any of which could harm our business , financial condition and results of operations . the source , timing and availability of any future financing will depend principally upon equity and debt market conditions , interest rates and , more specifically , our continued progress in our regulatory , development and commercial activities . we can not assure you that such capital funding will be available on favorable terms or at all . if we are unable to obtain sufficient additional funds when required , we may be forced to delay , restrict or eliminate all or a portion of our research or development programs , dispose of assets or technology or cease operations . off-balance sheet arrangements we do not have any off-balance sheet arrangements , other than operating leases , that have or are reasonably likely to have a current or future material effect on our financial condition , revenues or expenses , results of operations , liquidity , capital expenditures or capital resources . we do not have any interest in special purpose entities , structured finance entities or other variable interest entities . critical accounting policies preparation of financial statements in accordance with generally accepted accounting principles in the us requires us to make estimates and assumptions affecting the reported amounts of assets , liabilities , revenues and expenses and the disclosures of contingent assets and liabilities . we use our historical experience and other relevant factors when developing our estimates and assumptions . we continually evaluate these estimates and assumptions . the amounts of assets and liabilities reported in our consolidated balance sheets and the amounts of revenue reported in our consolidated statements of comprehensive loss are effected by estimates and assumptions , which are used for , but not limited to , the accounting for research and development , stock-based compensation , identifiable intangible assets , and accrued expenses . the accounting policies discussed below are considered critical to an understanding of our consolidated financial statements because their application places the most significant demands on our judgment . actual results could differ from our estimates . for additional accounting policies , see note 2 to our consolidated financial statements summary of significant accounting policies . 79 research and development research and development expenses consist primarily of salaries , benefits and other related costs , including stock-based compensation , for personnel serving our research and development functions , and other internal operating expenses , the cost of manufacturing our drug candidate for clinical study , including the medical devices for drug delivery , the cost of conducting clinical studies , and the cost of conducting preclinical and research activities . in addition , research and development expenses include payments to third parties for the license rights to products in development ( prior to marketing approval ) . our expenses related to manufacturing our drug candidate and medical devices

liquidity and capital resources overview there is considerable time and cost associated with developing a potential drug or pharmaceutical product to the point of regulatory approval and commercialization . in recent years , we have funded our operations through public offerings of equity securities and debt financings . we expect to continue to incur losses both in our us and certain international entities , as we plan to fund research and development activities and commercial launch activities . we will need to raise additional capital to fund our operations , to develop and commercialize arikayce , to develop ins1007 and ins1009 , and to develop , acquire , in-license or co-promote other products that address orphan or rare diseases . we believe we currently have sufficient funds to meet our financial needs for at least the next 12 months . we will opportunistically raise additional capital and may do so through equity or debt financing ( s ) , strategic transactions or otherwise . such additional funding will be necessary to continue to develop our potential product candidates , to pursue the license or purchase of other technologies , to commercialize our product candidates or to purchase other products . we can not assure you that adequate capital will be available on favorable terms , or at all , when needed . if we are unable to obtain sufficient additional funds when required , we may be forced to delay , restrict or eliminate all or a portion of our research or development programs , dispose of assets or technology or cease operations . during 2017 , we plan to continue to fund further clinical development of arikayce and ins1007 , support efforts to obtain regulatory approvals , and prepare for commercialization of arikayce . our cash requirements in 2017 will be impacted by a number of factors , the most significant of which , are expenses related to the convert study and 74 pre-commercialization efforts for arikayce , and to a lesser extent , research and clinical expenses related to ins1007 .


 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 overview there is considerable time and cost associated with developing a potential drug or pharmaceutical product to the point of regulatory approval and commercialization . in recent years , we have funded our operations through public offerings of equity securities and debt financings . we expect to continue to incur losses both in our us and certain international entities , as we plan to fund research and development activities and commercial launch activities . we will need to raise additional capital to fund our operations , to develop and commercialize arikayce , to develop ins1007 and ins1009 , and to develop , acquire , in-license or co-promote other products that address orphan or rare diseases . we believe we currently have sufficient funds to meet our financial needs for at least the next 12 months . we will opportunistically raise additional capital and may do so through equity or debt financing ( s ) , strategic transactions or otherwise . such additional funding will be necessary to continue to develop our potential product candidates , to pursue the license or purchase of other technologies , to commercialize our product candidates or to purchase other products . we can not assure you that adequate capital will be available on favorable terms , or at all , when needed . if we are unable to obtain sufficient additional funds when required , we may be forced to delay , restrict or eliminate all or a portion of our research or development programs , dispose of assets or technology or cease operations . during 2017 , we plan to continue to fund further clinical development of arikayce and ins1007 , support efforts to obtain regulatory approvals , and prepare for commercialization of arikayce . our cash requirements in 2017 will be impacted by a number of factors , the most significant of which , are expenses related to the convert study and 74 pre-commercialization efforts for arikayce , and to a lesser extent , research and clinical expenses related to ins1007 .
```    
 Suspicious Activity Report : in the fourth quarter of 2014 , we filed an maa with the european medicines agency ( ema ) for arikayce as a treatment for ntm lung disease in adult patients and for cystic fibrosis ( cf ) patients with pseudomonas lung infections . the filing was based on data from our phase 3 study in cf patients with pseudomonas and our phase 2 study in patients with ntm . in february 2015 , the ema validated our maa as complete for review . the ema subsequently requested additional information with respect to the cf indication regarding the similarity of arikayce to another product that has an orphan designation for the same pseudomonas indication . in the third quarter of 2015 , the ema adopted our request to withdraw the pseudomonas indication from our maa . in april 2016 , we submitted our written responses to the ema 's 180-day list of outstanding issues ( loi ) . in may 2016 , we participated in an oral explanation meeting with the chmp for the ntm indication to address the loi . after the oral explanation meeting , the chmp concluded that the data submitted did not provide enough evidence to support an approval . in june 2016 , we withdrew our maa . we intend to seek marketing approval for arikayce in the eu , japan and certain other countries outside the us when sufficient data are available . ins1007 ins1007 is a novel oral reversible inhibitor of dipeptidyl peptidase 1 ( dpp1 ) , an enzyme responsible for activating neutrophil serine proteases , which are implicated in the pathology of chronic inflammatory lung diseases , such as non-cystic fibrosis ( non-cf ) bronchiectasis . in october 2016 , we acquired the exclusive global rights to ins1007 ( formerly known as azd7986 ) from astrazeneca and we are finalizing our plans for a phase 2 study in our lead indication , non-cf bronchiectasis . in a phase 1 study of healthy volunteers , azd7986 was well tolerated and demonstrated inhibition of the activity of the neutrophil serine protease neutrophil elastase in a dose and concentration dependent manner . in preclinical studies , ins1007 was shown to reversibly inhibit dpp1 and the activation of neutrophil serine proteases within maturing neutrophils . we are defining our regulatory strategies to potentially secure us and eu orphan drug designations and expedite the development and regulatory review of ins1007 through programs such as us fast track designation and breakthrough therapy . we plan to submit an investigational new drug ( ind ) application to the us food and drug administration ( fda ) for non-cf bronchiectasis and subsequently commence a phase 2 clinical study of ins1007 . the study is expected to begin in 2017. in addition , we are evaluating ins1007 in other potential indications . ins1009 ins1009 is our inhaled nanoparticle formulation of a treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders , including pulmonary arterial hypertension ( pah ) . we have completed a phase 1 study of ins1009 in healthy subjects and the results were presented at the european respiratory society international congress in september 2016. this first-in-human study of ins1009 determined the maximum-tolerated dose of a single dose of ins1009 and characterized a pharmacokinetic profile that supports once- or twice-daily dosing . the longer 68 half-life of treprostinil associated with ins1009 was likely due to a sustained pulmonary release . we are currently evaluating our options to advance its development . other development activities our earlier-stage pipeline includes preclinical compounds that we are evaluating in multiple rare diseases of unmet medical need , including methicillin-resistant staph aureus ( mrsa ) and ntm . to complement our internal research and development , we actively evaluate in-licensing and acquisition opportunities for a broad range of rare diseases . key components of our results of operations research and development expenses research and development expenses consist primarily of salaries , benefits and other related costs , including stock-based compensation , for personnel serving in our research and development functions . expenses also include other internal operating expenses , the cost of manufacturing our drug candidate for clinical study , the cost of conducting clinical studies , and the cost of conducting preclinical and research activities . in addition , our research and development expenses include payments to third parties for the license rights to products in development ( prior to marketing approval ) , such as for ins1007 . our expenses related to manufacturing our drug candidate for clinical study are primarily related to activities at contract manufacturing organizations ( cmos ) that manufacture arikayce for our use . our expenses related to clinical trials are primarily related to activities at contract research organizations that conduct and manage clinical trials on our behalf . since 2011 , we have focused our development activities principally on our proprietary , advanced liposomal technology designed specifically for inhalation lung delivery . in 2015 , we commenced the convert study for arikayce for adult patients with treatment refractory ntm lung disease . in 2015 , we also completed an open-label extension study in which cf patients that completed our phase 3 trial received arikayce for a period of two years . the majority of our research and development expenses have been for our arikayce development programs . our development efforts in 2016 principally related to the development of arikayce in the ntm lung disease indication described above . general and administrative expenses general and administrative expenses consist primarily of salaries , benefits and other related costs , including stock-based compensation , for our non-management directors and personnel serving in our executive , finance and accounting , legal , pre-commercial , corporate development , information technology , program management and human resource functions . general and administrative expenses also include professional fees for legal , including patent-related expenses , consulting , insurance , board of director fees , tax and accounting services . story_separator_special_tag the az license agreement provides astrazeneca with the option to negotiate a future agreement with us for commercialization of ins1007 in chronic obstructive pulmonary disease or asthma . future funding requirements to date , we have not generated material revenue from arikayce , and we do not know when , or if , we will generate such revenue . we do not expect to generate such revenue unless or until we obtain marketing approval of , secure reimbursement for , and commercialize , arikayce . we will need to raise additional capital to fund our operations , to develop and commercialize arikayce , to develop ins1007 and ins1009 , and to develop , acquire , in-license or co-promote other products that address orphan or rare diseases . our future capital requirements may be substantial and will depend on many factors , including : · the timing and cost of our anticipated clinical trials of arikayce for the treatment of patients with ntm lung infections ; · the decisions of the fda and ema with respect to our applications for marketing approval of arikayce in the us and europe ; the costs of activities related to the regulatory approval process ; and the timing of approvals , if received ; · the cost of putting in place the sales and marketing capabilities necessary to be prepared for a potential commercial launch of arikayce , if approved ; · the cost of filing , prosecuting , defending , and enforcing patent claims ; · the timing and cost of our anticipated clinical trials , including ins1007 and the related milestone payments due to astrazeneca ; 78 · the costs of our manufacturing-related activities ; · the costs associated with commercializing arikayce , if we receive marketing approval ; and · subject to receipt of marketing approval , the levels , timing and collection of revenue received from sales of approved products , if any , in the future . in april 2015 , we generated net proceeds of $ 222.9 million from the issuance of 11.5 million shares of common stock . on september 30 , 2016 , the total committed amount under the a & r loan agreement with hercules was increased to $ 55.0 million , $ 25.0 million of which was previously outstanding . during the fourth quarter of 2016 , we drew down the remaining commitment . we believe we currently have sufficient funds to meet our financial needs for the next 12 months . however , our business strategy will require us to raise additional capital at any time through equity or debt financing ( s ) , strategic transactions or otherwise . such additional funding will be necessary to continue to develop our potential product candidates , to pursue the license or purchase of complementary technologies , to commercialize our product candidates or to purchase other products . if we are unable to obtain additional financing , we may be required to reduce the scope of our planned product development and commercialization or our plans to establish a sales and marketing force , any of which could harm our business , financial condition and results of operations . the source , timing and availability of any future financing will depend principally upon equity and debt market conditions , interest rates and , more specifically , our continued progress in our regulatory , development and commercial activities . we can not assure you that such capital funding will be available on favorable terms or at all . if we are unable to obtain sufficient additional funds when required , we may be forced to delay , restrict or eliminate all or a portion of our research or development programs , dispose of assets or technology or cease operations . off-balance sheet arrangements we do not have any off-balance sheet arrangements , other than operating leases , that have or are reasonably likely to have a current or future material effect on our financial condition , revenues or expenses , results of operations , liquidity , capital expenditures or capital resources . we do not have any interest in special purpose entities , structured finance entities or other variable interest entities . critical accounting policies preparation of financial statements in accordance with generally accepted accounting principles in the us requires us to make estimates and assumptions affecting the reported amounts of assets , liabilities , revenues and expenses and the disclosures of contingent assets and liabilities . we use our historical experience and other relevant factors when developing our estimates and assumptions . we continually evaluate these estimates and assumptions . the amounts of assets and liabilities reported in our consolidated balance sheets and the amounts of revenue reported in our consolidated statements of comprehensive loss are effected by estimates and assumptions , which are used for , but not limited to , the accounting for research and development , stock-based compensation , identifiable intangible assets , and accrued expenses . the accounting policies discussed below are considered critical to an understanding of our consolidated financial statements because their application places the most significant demands on our judgment . actual results could differ from our estimates . for additional accounting policies , see note 2 to our consolidated financial statements summary of significant accounting policies . 79 research and development research and development expenses consist primarily of salaries , benefits and other related costs , including stock-based compensation , for personnel serving our research and development functions , and other internal operating expenses , the cost of manufacturing our drug candidate for clinical study , including the medical devices for drug delivery , the cost of conducting clinical studies , and the cost of conducting preclinical and research activities . in addition , research and development expenses include payments to third parties for the license rights to products in development ( prior to marketing approval ) . our expenses related to manufacturing our drug candidate and medical devices

