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Entero Therapeutics, Inc.(ENTO) - 2022 Q4 - Annual Report
ENTOEntero Therapeutics, Inc.(ENTO)2023-03-20 20:10

Clinical Development - The company is focused on developing gut-restricted GI clinical drug candidates, including adrulipase and niclosamide [333]. - Adrulipase is designed to treat exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients, with topline data from a Phase 2b trial expected in Q3 2023 [334]. - The company completed enrollment in the FW-COV trial for COVID-19 GI infections in January 2022, but decided to discontinue this program due to mixed results [336]. - The company expects research and development expenses to increase as it focuses on late-stage clinical trials for product candidates niclosamide and adrulipase [357]. - The company anticipates general and administrative expenses to increase to support expanded research and development activities and business development efforts [361]. Financial Performance - The company reported a stockholders' deficit of (6,969,988)asofSeptember30,2021,failingtomeetNasdaq′sminimumstockholders′equityrequirementof(6,969,988) as of September 30, 2021, failing to meet Nasdaq's minimum stockholders' equity requirement of 2.5 million [342]. - The net loss for the year ended December 31, 2022 totaled approximately 14.6million,adecreaseofapproximately14.6 million, a decrease of approximately 43.9 million, or 75%, compared to the net loss of approximately 58.5millionfortheyearendedDecember31,2021[380].−Thecompanyhasnotgeneratedanyrevenuesandhasexperiencednetlossesandnegativecashflowsfromitsactivitiestodate[362].−ThetotaloperatingexpensesfortheyearendedDecember31,2022wereapproximately58.5 million for the year ended December 31, 2021 [380]. - The company has not generated any revenues and has experienced net losses and negative cash flows from its activities to date [362]. - The total operating expenses for the year ended December 31, 2022 were approximately 12.7 million, a decrease of approximately 46.4millioncomparedto46.4 million compared to 59.1 million for the year ended December 31, 2021 [372]. Cash Flow and Funding - As of December 31, 2022, the company had cash and cash equivalents of approximately 1.4millionandworkingcapitalofapproximately1.4 million and working capital of approximately 0.8 million [363]. - The company raised approximately 4.0millionfromaprivateplacementinMarch2023tosupportitsoperations[363].−Thecompanyisdependentonobtainingadditionalfundingfromoutsidesourcestocontinueitsoperationsandmaynotachieveprofitability[363].−NetcashusedinoperatingactivitiesfortheyearendedDecember31,2021wasapproximately4.0 million from a private placement in March 2023 to support its operations [363]. - The company is dependent on obtaining additional funding from outside sources to continue its operations and may not achieve profitability [363]. - Net cash used in operating activities for the year ended December 31, 2021 was approximately 32.3 million, primarily due to a net loss of approximately 58.5million,adjustedfornon−cashexpensesofapproximately58.5 million, adjusted for non-cash expenses of approximately 9.7 million [382]. - Net cash provided by financing activities for the year ended December 31, 2022 was approximately 15.7million,primarilyfromtheissuanceofcommonstockundertheATMAgreementfornetproceedsofapproximately15.7 million, primarily from the issuance of common stock under the ATM Agreement for net proceeds of approximately 7.7 million [385]. Expenses Overview - Research and development expenses for the year ended December 31, 2022 totaled approximately 8.8million,adecreaseofapproximately8.8 million, a decrease of approximately 8.2 million, or 48%, compared to 17.0millionfortheyearendedDecember31,2021[374].−GeneralandadministrativeexpensesfortheyearendedDecember31,2022totaledapproximately17.0 million for the year ended December 31, 2021 [374]. - General and administrative expenses for the year ended December 31, 2022 totaled approximately 12.0 million, a decrease of approximately 6.4million,or356.4 million, or 35%, compared to 18.4 million for the year ended December 31, 2021 [376]. Stock and Goodwill - A 1-for-30 reverse stock split was completed on August 26, 2022, to regain compliance with Nasdaq's bid price rule [344]. - The carrying value of goodwill was approximately 1.7millionand1.7 million and 1.9 million at December 31, 2022 and 2021, respectively, with a loss of approximately 1.7millionrecognizedrelatedtoforeigntranslationadjustmentsduringtheyearendedDecember31,2022[393].−Thecompanyrecognizedanimpairmentchargeofapproximately1.7 million recognized related to foreign translation adjustments during the year ended December 31, 2022 [393]. - The company recognized an impairment charge of approximately 2.4 million on patents acquired in the Mayoly APA during the year ended December 31, 2021 [390].