First Wave BioPharma

First Wave Biopharma, Inc. is a clinical stage biopharmaceutical company, which engages in the research and development of non-systemic therapies for the treatment of gastrointestinal diseases. The firm is involved in a therapeutic development pipeline populated with multiple clinical stage programs built around its proprietary technologies, such as Niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. Its programs include FW-UP, FW-UC, FW-CD, FW-COV, FW-ICI-AC, MS1819, COVID-19 GI infections, and FW-EPI. The company was founded on January 30, 2014 and is headquartered in Boca Raton, FL.

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Entero Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the research and development of non-systemic therapies for the treatment of gastrointestinal diseases. The firm is involved in a therapeutic development pipeline populated with multiple clinical stage programs built around its proprietary technologies, such as Niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. Its programs include FW-UP, FW-UC, FW-CD, FW-COV, FW-ICI-AC, MS1819, COVID-19 GI infections, and FW-EPI. The company was founded on January 30, 2014 and is headquartered in Boca Raton, FL.

BOCA RATON, Fla., Jan. 25, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ: FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today the company has filed a U.S. Provisional Patent application involving composition of matter improvements designed to enhance adrulipase's delayed release profile. This filing adds to the growing intellectual property (IP) portfolio governing adrulipase, which includes patent applications governing adrulipase formulation and methods of use and the utilization of enteric formulations in the delivery of adrulipase.

First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio

BOCA RATON, Fla., Jan. 24, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ:FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced James Sapirstein, Chairman, President and CEO, will present at the Sequire Biotechnology Conference being held virtually on February 2, 2023.

First Wave BioPharma to Present at Sequire Biotechnology Conference

First Wave's (FWBI) stock gains as FDA reviews its IND amendment for the planned phase II study of an enhanced enteric microgranule delivery formulation of adrulipase.

First Wave (FWBI) IND Filing Under FDA's Review, Stock Up

BOCA RATON, Fla., Jan. 13, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ:FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced that the U.S. Food and Drug Administration (FDA) is reviewing the Investigational New Drug (IND) amendment for the planned Phase 2 clinical trial of an enhanced enteric microgranule delivery formulation for adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP) as an IND protocol amendment. Under FDA's policy guidelines, the agency strives to complete its review of Phase 2 protocols within 60 days, but may take longer depending on available resources. The Company previously announced that it submitted the IND amendment to the FDA on November 30, 2022. First Wave BioPharma has been in conversations with FDA and expects a forthcoming response around the end of January.

First Wave BioPharma Provides Update on IND Filing For Phase 2 Trial of Enhanced Microgranule Formulation of Adrulipase for Exocrine Pancreatic Insufficiency

BOCA RATON, Fla., Jan. 13, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ:FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that the Company's stockholders have approved all proposals voted on at the Company's special meeting of stockholders (the “Special Meeting”) held on January 13, 2023.

First Wave BioPharma Announces Results of Special Meeting of Stockholders

BOCA RATON, Fla., Jan. 09, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has adjourned its Special Meeting of Stockholders (the “Special Meeting”) in order to provide stockholders additional time within which to vote on all proposals.

First Wave BioPharma Announces Adjournment of Special Meeting

BOCA RATON, Fla., Dec. 12, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ: FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today the company will participate in BIO Partnering @ JPM being held January 9-12, 2023 in San Francisco.

First Wave BioPharma to Participate in BIO Partnering @ JPM During “J.P. Morgan Week 2023”

Topline data expected by mid-2023 Topline data expected by mid-2023

First Wave BioPharma Announces Initial Clinical Sites for its Phase 2 Trial of Enhanced Microgranule Delivery Formulation of Adrulipase

Upon IND clearance, Phase 2 clinical trial investigating adrulipase as a treatment for exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis is expected to initiate in early 2023 with topline clinical data anticipated in the first half of 2023

First Wave BioPharma Files Investigational New Drug Application for Enhanced Microgranule Delivery Formulation of Adrulipase

BOCA RATON, Fla., Nov. 25, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ: FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-system therapies for gastrointestinal diseases, today announced that its Board of Directors declared a dividend of 0.001 of a share of newly-designated Series F Preferred Stock, par value $0.0001 per share, for each outstanding share of the Company's common stock held of record as of 5:00 p.m. Eastern Time on December 5, 2022. The outstanding shares of Series F Preferred Stock will vote together with the outstanding shares of the Company's common stock, as a single class, exclusively with respect to a reverse stock split, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the reverse stock split, and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series F Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per 0.001 of a share of Series F Preferred Stock).

First Wave BioPharma Announces Distribution of Series F Preferred Stock to Holders of Its Common Stock

BOCA RATON, Fla., Nov. 22, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ:FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal diseases, today announced the closing of its previously announced private placement for the issuance and sale of pre-funded warrants to purchase up to an aggregate of 4,166,667 shares of its common stock and warrants to purchase up to an aggregate of 8,333,334 shares of its common stock at an effective purchase price of $0.60 per share and accompanying warrants for aggregate gross proceeds of approximately $2.5 million, before deducting placement agent fees and other offering expenses. The issuance of the shares of common stock underlying the pre-funded warrants in excess of 19.99% of the shares of common stock outstanding prior to the offering and the issuance of the shares of common stock underlying the warrants are subject to stockholder approval under Nasdaq rules. The warrants have an exercise price of $0.7685 per share, will be exercisable upon the receipt of stockholder approval and will expire five and one-half years from the initial exercise date. In connection with the offering, the Company also agreed, subject to receipt of stockholder approval, to amend certain outstanding warrants to purchase up to an aggregate of 3,736,987 shares of common stock of the Company that were previously issued to the investor of the securities sold in the private placement to reduce the exercise price of the warrants to $0.7685 per share and to extend the term of the warrants until the five and one-half years from stockholder approval. The Company has agreed to call a special meeting of stockholders to seek the required stockholder approval.

First Wave BioPharma, Inc. Announces Closing of Private Placement

Phase 2 clinical trial investigating adrulipase as a treatment for exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis expected to initiate prior to year-end 2022 Phase 2 clinical trial investigating adrulipase as a treatment for exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis expected to initiate prior to year-end 2022

First Wave BioPharma Engages Rho to Manage Phase 2 Clinical Trial of Enhanced Adrulipase Formulation

BOCA RATON, Fla., Oct. 11, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ:FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal diseases, today announced the closing of its previously announced public offering of 3,438,396 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 3,438,396 shares of its common stock at an offering price to the public of $1.745 per share (or pre-funded warrant in lieu thereof) and associated warrant. The warrants have an exercise price of $1.62 per share, are exercisable immediately upon issuance, and will expire five years following the date of issuance.

First Wave BioPharma, Inc. Announces Closing of $6.0 Million Public Offering

Poster presentation indicates new microgranule formulation elicited desired delayed release profile, offering protection at acidic pH and rapid release under intestinal conditions Poster presentation indicates new microgranule formulation elicited desired delayed release profile, offering protection at acidic pH and rapid release under intestinal conditions

First Wave BioPharma Presents Research Demonstrating Benefits of Improved Adrulipase Drug Delivery Formulation at AAPS 2022 PharmSci 360

BOCA RATON, Fla., Oct. 06, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ:FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal diseases, today announced the pricing of a public offering of 3,438,396 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 3,438,396 shares of its common stock at an offering price to the public of $1.745 per share (or pre-funded warrant in lieu thereof) and associated warrant. The warrants will have an exercise price of $1.62 per share, are exercisable immediately upon issuance, and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about October 11, 2022, subject to the satisfaction of customary closing conditions.

First Wave BioPharma, Inc. Announces Pricing of $6.0 Million Public Offering

NEW YORK, NY / ACCESSWIRE / October 6, 2022 / Traders News Source, a leading independent equity research and corporate access firm focused on small and mid-cap publicly traded companies recently issued a new CEO interview with First Wave BioPharma. Toni had the pleasure of recently conducting the Interview with James Sapirstein, Chief Executive Officer of First Wave BioPharma, Inc. (NASDAQ:FWBI).

In a New Audio Interview, Toni Loudenbeck of Traders News Source Interviews James Sapirstein CEO, First Wave BioPharma, Inc.

BOCA RATON, Fla., Sept. 28, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chairman, President, and CEO of First Wave BioPharma, will give a presentation and take investor meetings at the Inaugural Roth Healthcare Opportunities Conference taking place October 6, 2022, in New York City.

First Wave BioPharma's CEO James Sapirstein to Present at Inaugural Roth Healthcare Opportunities Conference

After losing some value lately, a hammer chart pattern has been formed for First Wave BioPharma, Inc. (FWBI), indicating that the stock has found support. This, combined with an upward trend in earnings estimate revisions, could lead to a trend reversal for the stock in the near term.

Here's Why First Wave BioPharma, Inc. (FWBI) Could be Great Choice for a Bottom Fisher

BOCA RATON, Fla., Sept. 14, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chairman, President, and CEO of First Wave BioPharma, will moderate a panel discussion on drug development during the Longwood Healthcare Leaders Fall Webconference taking place September 21-22, 2022.

First Wave BioPharma CEO James Sapirstein to Moderate Panel Discussion at Longwood Healthcare Leaders Fall Webconference

Research involves microgranule delivery formulations for adrulipase Research involves microgranule delivery formulations for adrulipase

First Wave BioPharma Announces AAPS 2022 PharmSci 360 Accepts Adrulipase Formulation Abstract

BOCA RATON, Fla., Aug. 29, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chairman, President and CEO of First Wave BioPharma, will present at the 2022 H.C. Wainwright 24th Annual Global Investment Conference. The conference is taking place September 12-14, 2022, at the Lotte New York Palace Hotel, New York City.

First Wave BioPharma to Present at H.C. Wainwright 24th Annual Global Investment Conference 2022

BOCA RATON, Fla., Aug. 25, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ:FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal diseases, today announced that it intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 30 pre-split shares. First Wave's common stock will continue to be traded on the NASDAQ Capital Market under the symbol FWBI and will begin trading on a split-adjusted basis when the market opens on Friday, August 26, 2022, under a new CUSIP number, 33749P200.

First Wave BioPharma, Inc. Announces Reverse Stock Split

BOCA RATON, Fla., July 15, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ:FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal diseases, today announced that it has entered into a securities purchase agreement with several institutional accredited investors for the issuance and sale of (i) an aggregate of 150 shares of its Series D Convertible Preferred Stock, stated value $1,000 per share, (ii) 150 shares of its Series E Convertible Preferred Stock, stated value $1,000 per share, and (iii) Series D Warrants to purchase up to 2,000,000 shares of its common stock in a private placement for aggregate gross proceeds of approximately $300,000, before deducting placement agent fees and other offering expenses. The shares of Series D Convertible Preferred Stock are convertible into an aggregate of 1,000,000 shares of common stock of the Company and the shares of Series E Convertible Preferred Stock are convertible into an aggregate of 1,000,000 shares of common stock of the Company, in each case, at a conversion price of $0.15 per share. The Series D Warrants have an exercise price of $0.15 per share, are exercisable commencing upon the effectiveness of the Reverse Split described below, and will expire five years from the initial exercise date.

First Wave BioPharma, Inc. Announces Private Placement

First Wave BioPharma Inc (NASDAQ: FWBI) shares are plummeting after the company reported topline data from Phase 2 RESERVOIR trial of FW-COV, oral formulation of niclosamide, for COVID-19-related GI infections. FW-COV was very safe, with no serious adverse events reported by the more than 150.

Why First Wave BioPharma Shares Are Tanking Today

BOCA RATON, Fla., April 29, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chairman, President and CEO First Wave BioPharma, has issued a Letter to Shareholders to provide an update on recent events and an outlook for the Company's clinical programs in 2022.

News for First Wave BioPharma Stock (FWBI)