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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BOCA RATON, Fla., May 15, 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 that James Sapirstein, Chief Executive Officer of First Wave BioPharma, will present at the 2023 BIO International Conference on Tuesday, June 6 11:45 AM in Room 104A. The conference is taking place June 5-8 in the Boston Convention & Exhibition Center in Boston, Massachusetts.

First Wave BioPharma CEO James Sapirstein to Present at 2023 BIO International Conference

BOCA RATON, Fla., May 11, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. ("First Wave BioPharma" or the “Company”) (NASDAQ: FWBI), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has completed patient screening in its ongoing Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

First Wave BioPharma Completes Patient Screening For Phase 2 Span Adrulipase Clinical Trial in Cystic Fibrosis

BOCA RATON, Fla., May 02, 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 will participate in the EF Hutton Inaugural Global Conference being held May 10-11, 2023 at the Plaza Hotel in New York City.

First Wave BioPharma to Participate in EF Hutton Inaugural Global Conference

BOCA RATON, Fla., April 25, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. ("First Wave BioPharma" or the “Company”) (NASDAQ: FWBI), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has now surpassed the 50% enrollment target in its ongoing Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

First Wave Biopharma Exceeds 50% Enrollment Target for Phase 2 Span Adrulipase Clinical Trial in Cystic Fibrosis

Three U.S. clinical trial sites actively screening and enrolling patients; Topline data expected by mid-2023 Three U.S. clinical trial sites actively screening and enrolling patients; Topline data expected by mid-2023

First Wave BioPharma Announces Second Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation in Cystic Fibrosis

Topline data anticipated by mid-2023 Topline data anticipated by mid-2023

First Wave BioPharma Announces First Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation

BOCA RATON, Fla., Feb. 28, 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 participate in a “fireside chat” with Jonathan Aschoff, Ph.D., Managing Director and Senior Research Analyst at Roth Capital Partners during the 35 th Annual Roth Conference being held March 12-14, 2023, at the Ritz Carlton, Laguna Niguel in Dana Point, California.

First Wave BioPharma to Participate in ‘Fireside Chat' at the 35th Annual Roth Conference

Presentation to highlight clinical results examining adrulipase in combination with porcine pancreatic enzyme replacement therapy (PERT) as a treatment for severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) Presentation to highlight clinical results examining adrulipase in combination with porcine pancreatic enzyme replacement therapy (PERT) as a treatment for severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF)

First Wave BioPharma Announces Phase 2 Adrulipase Combination Trial Data to be Presented at the 2023 Digestive Disease Week (DDW) Conference

BOCA RATON, Fla., Feb. 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 James Sapirstein, Chairman, President and CEO of First Wave BioPharma, has issued a Letter to Stockholders providing an update on the Company's clinical programs and recent events. The full text of the letter follows.

First Wave BioPharma Chairman and CEO Issues Letter to Stockholders

Patient screening to initiate; topline data expected by mid-2023 Patient screening to initiate; topline data expected by mid-2023

First Wave BioPharma Announces Initiation of Phase 2 Trial Investigating Enhanced Adrulipase Formulation in Exocrine Pancreatic Insufficiency in Patients with Cystic Fibrosis

BOCA RATON, Fla., Jan. 30, 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 BIO CEO & Investor Conference being held February 6-9, 2023, at the Marriott Marquis in New York City.

First Wave BioPharma to Present at the BIO CEO & Investor Conference

Many Nasdaq stocks were in the red this morning, but not First Wave BioPharma (NASDAQ: FWBI ) stock. Indeed, First Wave shares were up substantially after the company announced an addition to its intellectual property (IP) portfolio governing a proprietary drug called adrulipase.

Why Is First Wave BioPharma (FWBI) Stock Up 30% Today?

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.

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