Niclosamide

First Wave BioPharma Chairman and CEO Issues Letter to Shareholders Highlighting Recent Accomplishments and Outlook for 2024

Retrieved on: 
Thursday, January 4, 2024
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BOCA RATON, Fla., Jan. 04, 2024 (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 and CEO of First Wave BioPharma, has issued a Letter to Stockholders highlighting the Company’s recent accomplishments and plans for 2024.

Key Points: 
  • BOCA RATON, Fla., Jan. 04, 2024 (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 and CEO of First Wave BioPharma, has issued a Letter to Stockholders highlighting the Company’s recent accomplishments and plans for 2024.
  • The close of 2023 has been an exciting period for First Wave BioPharma, highlighted by the recently announced potential business combination with ImmunogenX.
  • The non-binding term sheet includes a low seven-figure payment to First Wave BioPharma along with economics related to future milestones and royalties.
  • 2024 has the potential to be a year of significant growth for First Wave BioPharma, and once again, I thank all of our stockholders for your continued support.

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

Retrieved on: 
Monday, December 12, 2022
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First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

Key Points: 
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • First Wave is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP).
  • First Wave BioPharma is headquartered in Boca Raton, Florida.
  • This press release may contain certain statements relating to future results which are forward-looking statements.

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

Retrieved on: 
Monday, December 5, 2022
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First Wave BioPharma met with each of the investigators during the recently-held North American Cystic Fibrosis Conference in Philadelphia.

Key Points: 
  • First Wave BioPharma met with each of the investigators during the recently-held North American Cystic Fibrosis Conference in Philadelphia.
  • This ‘pill burden’ presents a substantial challenge for EPI patients,” said Dr. Steven Boas, M.D, founder of the Cystic Fibrosis Institute and Cystic Fibrosis Center of Chicago.
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • First Wave is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP).

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

Retrieved on: 
Wednesday, November 30, 2022
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BOCA RATON, Fla., Nov. 30, 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 that it has submitted an Investigational New Drug (IND) application seeking authorization from the U.S. Food and Drug Administration (FDA) to evaluate an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP) in human clinical trials. Upon IND clearance, First Wave expects to initiate a Phase 2 trial at the beginning of 2023.

Key Points: 
  • Upon IND clearance, First Wave expects to initiate a Phase 2 trial at the beginning of 2023.
  • Filing the IND is an important step in enabling First Wave to initiate the planned Phase 2 trial of our new formulation for adrulipase, said James Sapirstein, President and CEO of First Wave BioPharma.
  • In vitro data suggest the microgranule drug delivery formulation offers improved protection against the acidic pH in the stomach followed by the rapid release of adrulipase in the small intestine where the drug is expected to mix with food and deliver its therapeutic benefit.
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

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

Retrieved on: 
Friday, November 25, 2022
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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 0.001of a share of Series F Preferred Stock).

Key Points: 
  • 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 0.001of a share of Series F Preferred Stock).
  • The Series F Preferred Stock will be uncertificated, and no shares of Series F Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Companys common stock held by such holder.
  • In that case, a number of one one-thousandths (1/1000ths)of a share of Series F Preferred Stock equal to the number of shares of the Companys common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.
  • Further details regarding the Series F Preferred Stock will be contained in a Form8-Kto be filed by the Company with the Securities and Exchange Commission.

First Wave BioPharma, Inc. Announces Closing of Private Placement

Retrieved on: 
Tuesday, November 22, 2022
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The Company has agreed to call a special meeting of stockholders to seek the required stockholder approval.

Key Points: 
  • The Company has agreed to call a special meeting of stockholders to seek the required stockholder approval.
  • H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • These forward-looking statements are subject to risks and uncertainties including, among other things, the intended use of proceeds from the private placement.

First Wave BioPharma, Inc. Announces Private Placement

Retrieved on: 
Monday, November 21, 2022
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The Company has agreed to call a special meeting of stockholders to seek the required stockholder approval.

Key Points: 
  • The Company has agreed to call a special meeting of stockholders to seek the required stockholder approval.
  • H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the private placement, the satisfaction of customary closing conditions related to the private placement and the intended use of proceeds from the private placement.

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

Retrieved on: 
Monday, October 31, 2022
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First Wave BioPharma is developing adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP).

Key Points: 
  • First Wave BioPharma is developing adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP).
  • Under the agreement, Rho will manage the Phase 2 clinical trial of the microgranule drug delivery formulation of adrulipase.
  • We are eager to evaluate the potential of our new formulation in the proof-of-concept Phase 2 clinical trial, which we expect to initiate before year-end.
  • We look forward to being a valued partner to First Wave BioPharma in the management of the soon-to-be-initiated Phase 2 trial.

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

Retrieved on: 
Tuesday, October 11, 2022
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The gross proceeds to the Company from the offering were approximately $6.0 million, before deducting the placement agents fees and other offering expenses payable by the Company.

Key Points: 
  • The gross proceeds to the Company from the offering were approximately $6.0 million, before deducting the placement agents fees and other offering expenses payable by the Company.
  • The Company intends to use the remaining net proceeds from this offering for working capital and general corporate purposes.
  • The public offering was made only by means of a prospectus, which is part of the effective registration statement.
  • These forward-looking statements are subject to risks and uncertainties including, among other things, the intended use of proceeds from the public offering.

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

Retrieved on: 
Monday, October 10, 2022
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A Phase 2 clinical trial investigating the optimized adrulipase formulation is expected to initiate before year-end 2022.

Key Points: 
  • A Phase 2 clinical trial investigating the optimized adrulipase formulation is expected to initiate before year-end 2022.
  • The poster (W0930-01-02), entitled, Formulation Development of Enterically Protected Spray Dried Dispersions of Adrulipase, highlights research conducted by First Wave BioPharma and its drug delivery formulation partner, Pace Life Sciences, involving the development of a new drug delivery formulation for adrulipase.
  • Notably, the SDD04 formulation contained approximately two times higher drug load than previous formulations and retained activity even after 90 minutes under dissolution conditions.
  • We are very pleased that research into the development of a microgranule delivery formulation for adrulipase will be highlighted at the AAPS 2022 PharmSci 360 conference, said James Sapirstein, President and CEO of First Wave BioPharma.