Financial Position - First Wave BioPharma reported a stockholders' deficit of $(6,969,988) as of September 30, 2021, indicating non-compliance with Nasdaq's $2.5 million minimum stockholders' equity requirement[188]. - As of June 30, 2022, the company had cash and cash equivalents of approximately $1.2 million and cumulative losses attributable to common stockholders of approximately $168.9 million[204]. - The company anticipates needing to generate significant product revenues to achieve profitability and may never achieve profitability[204]. - The company recorded a net decrease in cash and cash equivalents of approximately $7.1 million for the six months ended June 30, 2022[233]. Clinical Trials and Development - The company initiated a Phase 2b monotherapy trial for adrulipase in the second half of 2022, focusing on treating exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients[177]. - The Phase 2 RESERVOIR COVID-19 GI clinical trial for niclosamide did not meet its efficacy endpoint, but demonstrated safety with no serious adverse events reported among over 150 participants[179]. - The company is evaluating further development of niclosamide therapies for additional inflammatory bowel disease indications, including ulcerative colitis and Crohn's disease[181]. - The FDA granted clearance for an investigational new drug application for a Phase 2 trial targeting immune checkpoint inhibitor-associated colitis, which is currently on hold due to financial constraints[181]. Financial Performance - For the three months ended June 30, 2022, total operating expenses were approximately $5.4 million, a decrease of approximately $3.9 million, or 42%, compared to approximately $9.3 million for the same period in 2021[221]. - Research and development expenses for the three months ended June 30, 2022, totaled approximately $2.9 million, a decrease of approximately $2.7 million, or 49%, compared to approximately $5.6 million for the same period in 2021[213]. - General and administrative expenses for the three months ended June 30, 2022, totaled approximately $2.5 million, a decrease of approximately $1.1 million, or 31%, compared to approximately $3.6 million for the same period in 2021[218]. - The net loss for the three months ended June 30, 2022, was approximately $5.4 million, a decrease of approximately $3.9 million, or 42%, compared to approximately $9.3 million for the same period in 2021[221]. - For the six months ended June 30, 2022, total operating expenses were approximately $14.8 million, a decrease of approximately $2.7 million, or 15%, compared to approximately $17.5 million for the same period in 2021[222]. - Research and development expenses for the six months ended June 30, 2022, totaled approximately $7.9 million, a decrease of approximately $0.3 million, or 3%, compared to approximately $8.2 million for the same period in 2021[223]. - General and administrative expenses for the six months ended June 30, 2022, totaled approximately $6.9 million, a decrease of approximately $2.4 million, or 26%, compared to approximately $9.3 million for the same period in 2021[228]. - The net loss for the six months ended June 30, 2022, was approximately $15.0 million, a decrease of 11% from the net loss of approximately $16.9 million for the same period in 2021[232]. Cost Management - The company has implemented cost-reduction measures, including headcount reduction and closure of facilities, to conserve capital amid ongoing volatility in the biotechnology sector[182]. - General and administrative expenses decreased by approximately $1.9 million, primarily due to reductions in public company costs, stock-based compensation, and advisory fees[229]. - The company expects general and administrative expenses to decrease for the remainder of the fiscal year due to capital conservation efforts[230]. Financing Activities - The company reached a settlement agreement on July 29, 2022, agreeing to pay $1.5 million in cash immediately, with additional payments totaling $3.0 million due by November 30, 2022, contingent on certain milestones[183]. - The company has entered into Temporary Waivers with holders of approximately $2.88 million of stated value of Series B Preferred Stock to waive certain rights related to subsequent financing[195]. - The Permanent Waiver was executed by holders of 81.3% of the outstanding shares of Series B Preferred Stock, waiving their exchange rights for any subsequent financing occurring on or after January 1, 2022[197]. - Net cash provided by financing activities for the six months ended June 30, 2022, was approximately $5.4 million, mainly from the net proceeds of approximately $8.0 million from a registered direct offering[237]. Other Financial Information - Other expenses for the six months ended June 30, 2022, totaled approximately $0.2 million, an increase of 147% compared to other income of approximately $(0.5) million for the same period in 2021[231]. - Cash flows from investing activities for the six months ended June 30, 2021, included approximately $9.0 million related to the FWB License Agreement[236]. - The net cash used in investing activities for the six months ended June 30, 2021, was approximately $9.1 million, primarily for the FWB License Agreement[236]. - There were no material changes in internal control over financial reporting during the period covered by the report[243].
First Wave BioPharma(FWBI) - 2022 Q2 - Quarterly Report