Financial Position - As of March 31, 2022, the company had cash and cash equivalents of approximately $5.7 million and cumulative losses attributable to common stockholders of approximately $163.5 million[168]. - The company anticipates having sufficient cash to fund planned operations into June 2022, but may need to raise additional capital depending on cash outflows[168]. - The company entered into waivers with holders of approximately $2.88 million of stated value of its Series B Preferred Stock to manage its financial obligations[164]. - The company is subject to potential delisting from Nasdaq due to non-compliance with minimum stockholders' equity requirements[161]. Operational Changes - The company has initiated a 20% reduction in headcount and closed its California office to conserve capital due to financial constraints[160]. - The company is implementing capital conservation measures, including headcount reductions, to manage expenses[179]. - The company is seeking to renegotiate obligations to former FWB stockholders to conserve capital, with no assurance of successful restructuring[175]. Clinical Development - The company received FDA clearance for an IND application for a Phase 2 trial for Immune Checkpoint Inhibitor-associated colitis, but the program is currently on hold[160]. - The company is focused on developing adrulipase and niclosamide, with ongoing Phase 2 clinical trials for both drug candidates[156][170]. - The company has been impacted by the COVID-19 pandemic, which has caused delays in clinical trial patient enrollment[165]. Financial Performance - For the three months ended March 31, 2022, total operating expenses were approximately $9.4 million, an increase of $1.2 million, or 14% compared to $8.2 million for the same period in 2021[176]. - Research and development expenses for the three months ended March 31, 2022 totaled approximately $5.0 million, an increase of approximately $2.5 million, or 98% over the approximately $2.5 million recorded for the same period in 2021[177]. - The increase in research and development expenses was primarily due to a $2.2 million rise in clinical-related expenses for the Phase 2 RESERVOIR COVID-19 GI clinical trial compared to two Phase 2 clinical trials related to adrulipase in the prior year[178]. - General and administrative expenses for the three months ended March 31, 2022 totaled approximately $4.4 million, a decrease of approximately $1.3 million, or 23% from $5.7 million in the same period in 2021[181]. - The net loss for the three months ended March 31, 2022 was approximately $9.6 million, an increase of approximately $1.9 million, or 25% compared to the net loss of approximately $7.7 million for the same period in 2021[185]. - Net cash used in operating activities for the three months ended March 31, 2022 was approximately $7.9 million, compared to $5.1 million for the same period in 2021[186]. - Net cash provided by financing activities for the three months ended March 31, 2022 was approximately $5.4 million, primarily due to net proceeds of approximately $8.0 million from a registered direct offering[189]. - The company expects research and development expenses to decrease as it nears completion of two clinical trials for niclosamide[179]. Going Concern - The company has not generated any revenues to date and continues to incur net losses, raising substantial doubt about its ability to continue as a going concern[167][170]. - The company is evaluating potential asset acquisitions and partnerships to expand its product pipeline[171].
First Wave BioPharma(FWBI) - 2022 Q1 - Quarterly Report