Clinical Development - The company is focused on developing gut-restricted GI clinical drug candidates, including adrulipase and niclosamide [340]. - 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 [342]. - 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 [344]. - The company expects research and development expenses to increase in the foreseeable future as it focuses on clinical development efforts for product candidates [369]. - The company anticipates general and administrative expenses to increase to support expanded research and development activities and business development efforts [373]. Financial Performance - The company reported a stockholders' deficit of $(6,969,988) as of September 30, 2021, failing to meet Nasdaq's minimum stockholders' equity requirement of $2.5 million [351]. - The net loss for the year ended December 31, 2022, totaled approximately $14.6 million, a decrease of approximately $43.9 million, or 75%, compared to the net loss of approximately $58.5 million for the year ended December 31, 2021 [394]. - The total operating expenses for the year ended December 31, 2022, were approximately $12.7 million, a decrease of approximately $46.4 million compared to $59.1 million for the year ended December 31, 2021 [384]. - The company has not generated any revenues and has experienced net losses and negative cash flows from its activities [374]. - The company raised approximately $4.0 million from a private placement in March 2023, following cumulative losses of approximately $168.5 million as of December 31, 2022 [375]. Cash Flow and Funding - Net cash used in operating activities for the year ended December 31, 2022, was approximately $22.3 million, primarily due to a net loss of approximately $14.6 million and a decrease in payables related to the FWB acquisition of approximately $8.1 million [396]. - Net cash provided by financing activities for the year ended December 31, 2022, was approximately $15.7 million, mainly from the issuance of common stock under the ATM Agreement for net proceeds of approximately $7.7 million [400]. - The company is dependent on obtaining additional funding from outside sources to continue operations and may face substantial doubt about its ability to continue as a going concern [375]. Expenses and Impairments - Research and development expenses for the year ended December 31, 2022, totaled approximately $8.8 million, a decrease of approximately $8.2 million, or 48%, compared to $17.0 million for the year ended December 31, 2021 [386]. - General and administrative expenses for the year ended December 31, 2022, totaled approximately $12.0 million, a decrease of approximately $6.4 million, or 35%, compared to $18.4 million for the year ended December 31, 2021 [389]. - 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 [405]. - Non-cash expenses for the year ended December 31, 2022, included approximately $2.8 million, mainly related to the dissolution of a foreign subsidiary [396]. 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 [354]. - The carrying value of goodwill was approximately $1.7 million and $1.9 million at December 31, 2022, and 2021, respectively, with a loss of approximately $1.7 million recognized related to foreign translation adjustments [408]. - The company performed its review of goodwill on its one reporting unit, with estimates impacting the carrying value of assets and liabilities [407].
First Wave BioPharma(FWBI) - 2022 Q4 - Annual Report