Welcome to our dedicated page for First Wave BioPharma news (Ticker: FWBI), a resource for investors and traders seeking the latest updates and insights on First Wave BioPharma stock.
First Wave BioPharma, Inc. (FWBI) is a leading biopharmaceutical company dedicated to developing non-systemic, recombinant protein therapies targeting gastrointestinal diseases and related conditions. Headquartered in New York, NY, with scientific operations based in Langlade, France, First Wave BioPharma aims to be at the forefront of innovative treatments in the biotech industry.
The company's flagship development program is MS1819 recombinant lipase, which is in advanced stages of development for treating exocrine pancreatic insufficiency (EPI). This condition often affects patients with cystic fibrosis and chronic pancreatitis, and MS1819 offers a promising alternative to current enzyme replacement therapies.
Besides MS1819, First Wave BioPharma is working diligently on early-stage research projects aimed at preventing hospital-acquired infections, further solidifying its focus on significant unmet medical needs.
In 2024, First Wave BioPharma plans to advance its gastrointestinal (GI) development pipeline significantly. The company expects to add the Phase 3 Latiglutenase celiac disease program and multiple Phase 2 clinical programs featuring Capeserod and Adrulipase. These initiatives are contingent upon the potential merger with ImmunogenX, a deal that could mark a year of substantial growth for the company.
Recent news highlights multiple clinical and development milestones anticipated in 2024, including the initiation of a Phase 3 clinical trial investigating latiglutenase in celiac disease. This trial is pivotal for the company's future, given the significant growth potential it represents in treating celiac disease effectively.
For detailed information and the latest updates, reach out to First Wave BioPharma at their Boca Raton office or through their media contact at Tiberend Strategic Advisors, Inc.
First Wave BioPharma (NASDAQ:FWBI) announced the acceptance of an abstract for a poster presentation at the 2022 Digestive Disease Week Conference highlighting research on niclosamide as a treatment for ulcerative proctitis and ulcerative proctosigmoiditis. The study, led by Dr. Giovanni Monteleone, showcases data from a Phase 1 open label study and aims to underscore the potential of niclosamide, demonstrating clinical remission rates exceeding those of budesonide. First Wave is advancing a Phase 2 clinical trial of FW-UP, a niclosamide formulation.
First Wave BioPharma, Inc. (NASDAQ: FWBI) announced the successful closing of its registered direct offering, selling 6,498,195 shares of common stock and warrants, yielding approximately $9 million in gross proceeds. The offering was priced at $1.385 per share, with warrants exercisable at $1.26. Proceeds will support the acquisition of First Wave Bio, Inc. and fund product manufacturing, clinical development, and general corporate purposes. The transaction was facilitated by H.C. Wainwright & Co. and is structured under an effective Form S-3 registration with the SEC.
First Wave BioPharma (NASDAQ: FWBI) has announced the appointment of Sarah Romano as Chief Financial Officer, effective immediately. With a 20-year background in corporate finance, Romano has led successful capital raises exceeding $50 million in her previous roles. Her experience includes positions as CFO at Kiora Pharmaceuticals and corporate controller at TechTarget. Romano expressed excitement about driving growth at First Wave, focusing on clinical programs for gastrointestinal diseases and enhancing shareholder value.
First Wave BioPharma (FWBI) has announced a registered direct offering of 6,498,195 shares and corresponding warrants to a healthcare-focused institutional investor, priced at $1.385 per share. The offering is expected to yield approximately $9 million in gross proceeds, intended to fund part of the acquisition of First Wave Bio, Inc., along with general corporate purposes, including clinical development and manufacturing. The warrants are exercisable immediately at an exercise price of $1.26 per share, expiring five years post-issuance. Closing is anticipated by March 2, 2022.
First Wave BioPharma (NASDAQ:FWBI) announced that James Sapirstein, Chairman and CEO, will present virtually at the 2022 BIO CEO & Investor Conference from February 14-17, 2022. The conference offers both in-person and virtual participation, allowing registered attendees to view a pre-recorded presentation discussing the company's business, achievements, and future milestones. Members of First Wave’s management will also be available for one-on-one meetings with investors. The company focuses on developing targeted therapies for gastrointestinal diseases, leveraging proprietary technologies including niclosamide.
First Wave BioPharma (FWBI) has filed two provisional patent applications for a new enteric granule formulation of adrulipase, aimed at enhancing dietary absorption in patients with exocrine pancreatic insufficiency (EPI). The World Health Organization (WHO) approved 'adrulipase alfa' as the drug's International Nonproprietary Name (INN). Phase 2b pilot study initiation is anticipated in Q3 2022. The innovative formulation will potentially improve treatment options compared to existing therapies, with patent claims expected to extend until 2042.
First Wave BioPharma, Inc. (NASDAQ:FWBI) has adjourned its Annual Meeting of Stockholders to provide additional time for stockholders to vote on various proposals, particularly Proposal 2, which seeks to amend the certificate of incorporation to increase authorized shares from 25 million to 50 million. Although around 85% of the votes cast on Proposal 2 were in favor, it did not receive a majority of outstanding shares. The meeting will reconvene on January 14, 2022, at 9:00 a.m. EST, and stockholders can vote live or online.
First Wave BioPharma (FWBI) announced the completion of enrollment for Part 2 of the RESERVOIR Phase 2 trial, assessing the efficacy of FW-COV, an oral niclosamide formulation, for COVID-19-related gastrointestinal infections. The trial included 150 participants randomized for either FW-COV or placebo over 14 days, followed by a six-week observation period. Importantly, no drug-related serious adverse events (SAEs) were reported. Top-line data is expected in the first half of 2022, with potential Emergency Use Authorization application later this year pending successful results.
First Wave BioPharma, a clinical-stage biopharmaceutical company, announced that CEO James Sapirstein will moderate a panel on novel therapeutic modalities at the Longwood Healthcare Leaders Conference on January 7, 2022. The conference takes place virtually from January 6-7, 2022. Additionally, Sapirstein will host a pre-recorded presentation at the H.C. Wainwright BioConnect 2022, occurring from January 10-13, 2022, where he will discuss First Wave's business and milestones.
First Wave BioPharma (FWBI) announced the adjournment of its 2021 Annual Meeting of Stockholders to allow more time for voting on key proposals. Specifically, Proposal 2 aims to increase authorized shares from 25 million to 50 million. Currently, 83% of votes cast support this proposal, but it requires a majority of outstanding shares to pass. The adjourned meeting is set for January 7, 2022. The company continues to advocate for this proposal, deeming it in the best interests of stockholders.
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