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., Sept. 15, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave” 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, President and CEO, will make a company presentation at the BIO Investor Forum being held October 17-18, 2023, at the Hilton San Francisco Union Square in San Francisco.

First Wave BioPharma To Present at the BIO Investor Forum

BOCA RATON, Fla., Sept. 14, 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 it has entered into agreements with certain holders of its existing warrants exercisable for 5,882,036 shares of its common stock, in the aggregate, to exercise their warrants at a reduced exercise price of $0.43 per share, in exchange for new warrants as described below. The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $4.0 million, before deducting financial advisory fees. The reduction in the exercise price of the existing warrants and the issuance of the new warrants was structured as an at-market transaction under Nasdaq rules.

First Wave BioPharma Announces Exercise of Warrants and Issuance of New Warrants in a Private Placement for $4.0 Million Gross Proceeds Priced At-the-Market

Sanofi

Shares of First Wave BioPharma Inc. FWBI, +8.61% soared 71.7% in active premarket trading Thursday, after the biopharmaceutical company announced an agreement to license Capeserod to Sanofi SNY, -0.73%, which First Wave will repurpose and develop for gastrointestinal indications. Trading volume swelled to 6.5 million shares, already more than double the full-day average of about 2.6 million shares, and enough to make the stock the third-most actively traded in Thursday's premarket.

First Wave BioPharma stock soars in active trading after Sanofi license deal

First Wave to develop and repurpose Capeserod for gastrointestinal (GI) indications based on AI-empowered analyses, expanding the company's GI-focused pipeline First Wave to develop and repurpose Capeserod for gastrointestinal (GI) indications based on AI-empowered analyses, expanding the company's GI-focused pipeline

First Wave BioPharma Announces Exclusive Global License Agreement for Capeserod from Sanofi

BOCA RATON, Fla., July 19, 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 diseases, today announced the pricing of a public offering of 3,285,000 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 6,570,000 shares of its common stock at a combined public offering price $0.64 per share (or pre-funded warrant in lieu thereof) and associated warrants. Each share of common stock (or prefunded warrant in lieu thereof) is being sold together with two warrants, each to purchase one share of common stock. The warrants will have an exercise price of $0.64 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 July 21, 2023, subject to the satisfaction of customary closing conditions.

First Wave BioPharma, Inc. Announces Pricing of $2.1 Million Public Offering

Initial data from First Wave's (FWBI) mid-stage study evaluating its investigational oral capsule in cystic fibrosis patients did not likely meet its primary endpoint.

First Wave (FWBI) Down 32% on Cystic Fibrosis Study Setback

BOCA RATON, Fla., July 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 the Company has received topline results from the Company's 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). Initial data from the study indicate the enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase. However, the preliminary data also indicate that it is likely the primary efficacy endpoint was not achieved. First Wave BioPharma is continuing to assess the data and expects to report additional findings on primary and secondary endpoints in approximately eight weeks.

First Wave BioPharma Announces Initial Topline Results from Phase 2 SPAN Clinical Trial Investigating Enhanced Adrulipase Formulation

Last patient completes last visit in Adrulipase Phase 2 clinical trial Last patient completes last visit in Adrulipase Phase 2 clinical trial

First Wave BioPharma Chairman and CEO Issues Letter to Stockholders

BOCA RATON, Fla., June 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, today announced that the final patient was dosed in the 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 Announces Final Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation

USPTO and WIPO both publish two adrulipase patent applications for composition of matter and methods of use claims involving new enteric formulation and malabsorption indication USPTO and WIPO both publish two adrulipase patent applications for composition of matter and methods of use claims involving new enteric formulation and malabsorption indication

First Wave BioPharma Strengthens Intellectual Property Estate

BOCA RATON, Fla., June 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 that it will attend the Cystic Fibrosis Research Institute's (CFRI) 36th National Cystic Fibrosis Education Conference being held July 28-30, 2023, at the Grand Bay Hotel San Francisco in Redwood City, California.

First Wave BioPharma to Attend the 36th National Cystic Fibrosis Education Conference (July 28-30)

First Wave (FWBI) completes enrolment in a mid-stage study evaluating its investigational oral capsule in patients with cystic fibrosis. Topline data from the study is expected next month.

First Wave (FWBI) Surges 33% on Finishing Enrolment in CF Study

BOCA RATON, Fla., June 13, 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 it has entered into agreements with certain holders of its existing warrants exercisable for 1,681,667 shares of its common stock, in the aggregate, to exercise their warrants at a reduced exercise price of $1.15 per share, in exchange for new warrants as described below. The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $2.4 million, before deducting financial advisory fees. The reduction in the exercise price of the existing warrants and the issuance of the new warrants was structured as an at-market transaction under Nasdaq rules.

First Wave BioPharma Announces Exercise of Warrants and Issuance of New Warrants in a Private Placement for $2.4 Million Gross Proceeds Priced At-the-Market

BOCA RATON, Fla., June 13, 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 achieved the 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 Reaches Enrollment Target for Phase 2 SPAN Adrulipase Clinical Trial in Cystic Fibrosis

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

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.

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