First Wave BioPharma, Inc. - FWBI STOCK NEWS

First Wave BioPharma announced the upcoming initiation of a Phase 2 clinical trial for adrulipase, aimed at treating exocrine pancreatic insufficiency (EPI) linked to cystic fibrosis (CF) and chronic pancreatitis (CP). This trial, managed by the contract research organization Rho, is expected to start by the end of 2022. The new microgranule formulation of adrulipase could reduce the daily pill burden for patients, who currently may take up to 40 capsules daily. The company is optimistic about this formulation's potential benefits based on promising in vitro data.

First Wave BioPharma (NASDAQ:FWBI) announced the closure of a public offering involving 3,438,396 shares of common stock and warrants, priced at $1.745 per share, generating approximately $6 million in gross proceeds. The company plans to use these funds primarily for a final payment to former stockholders of First Wave Bio, Inc. under a settlement agreement, along with working capital and corporate purposes. The offering was facilitated by H.C. Wainwright & Co., and the securities were registered with the SEC under Form S-1.

First Wave BioPharma (NASDAQ:FWBI) announces its poster presentation detailing a new microgranule formulation of adrulipase, showcasing a targeted delayed release profile effective in both acidic and intestinal environments. The findings, presented at AAPS 2022 PharmSci 360 on October 19, indicate that this formulation may enhance drug delivery for treating exocrine pancreatic insufficiency (EPI) linked to cystic fibrosis and chronic pancreatitis. The Company aims to initiate a Phase 2 clinical trial by year-end 2022. They reported significant advancements in manufacturing yields and reductions in production costs.

First Wave BioPharma (NASDAQ:FWBI) announced a public offering of 3,438,396 shares at $1.745 per share, aiming to raise around $6 million. The offering includes warrants exercisable at $1.62, valid for five years. The company plans to utilize the proceeds for a final payment to former stockholders of First Wave Bio, Inc., with remaining funds allocated for working capital and corporate purposes. The offering is facilitated by H.C. Wainwright & Co. and is expected to close around October 11, 2022, pending customary conditions.

First Wave BioPharma (NASDAQ: FWBI) announced that James Sapirstein, Chairman, President, and CEO, will present at the Inaugural Roth Healthcare Opportunities Conference on October 6, 2022, in New York City. The presentation begins at 1.15 P.M. ET at The Yale Club. This event offers an opportunity for investors to engage with company leadership regarding its advancements in targeted therapies for gastrointestinal diseases.

First Wave BioPharma is known for its proprietary technologies aimed at treating conditions like exocrine pancreatic insufficiency and inflammatory bowel diseases.

First Wave BioPharma (FWBI) announced significant updates regarding its clinical programs, specifically the adrulipase formulation for treating exocrine pancreatic insufficiency (EPI). The company plans to submit an IND application to the FDA for a Phase 2 study of the enhanced formulation, expected to start by year-end 2022. This new formulation aims to improve therapeutic efficacy and reduce pill burden for patients. Additionally, First Wave has improved its balance sheet by eliminating $10 million in liabilities and has completed funding through an at-the-market sales program.

First Wave BioPharma (NASDAQ: FWBI) announced that its CEO, James Sapirstein, will moderate a panel on drug development at the Longwood Healthcare Leaders Fall Webconference on September 22, 2022. The panel, titled “Accelerating Drug Development,” includes leaders from several biotech firms, focusing on innovation in drug development for gastrointestinal diseases. First Wave BioPharma is advancing clinical programs targeting gastrointestinal disorders, utilizing proprietary technologies aimed at improving patient outcomes.

First Wave BioPharma (NASDAQ: FWBI) announced the selection of an enhanced drug delivery formulation for adrulipase, aimed at treating exocrine pancreatic insufficiency (EPI) related to cystic fibrosis and chronic pancreatitis. The company plans to submit an Investigational New Drug amendment to the FDA and initiate a Phase 2 proof-of-concept trial by year-end 2022. The new formulation shows improved delayed-release characteristics and could reduce the daily pill burden on patients. Findings from this research will be presented at AAPS 2022 PharmSci 360 in October.

First Wave BioPharma (NASDAQ:FWBI) announced the acceptance of an abstract titled "Formulation Development of Enterically Protected Spray Dried Dispersions of Adrulipase" for the AAPS 2022 PharmSci 360 conference, scheduled for Oct. 16-19 in Boston. The research focuses on developing microgranule delivery formulations for adrulipase, an experimental treatment for exocrine pancreatic insufficiency (EPI). The company, partnering with Pace Life Sciences, aims to improve drug delivery to the small intestine, with clinical trials planned for this year.