FWBI - First Wave BioPharma Chairman and CEO Issues Letter to Shareholders Highlighting Recent Accomplishments and Outlook for 2024 | Benzinga
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 full text of the letter follows.
A MESSAGE FROM OUR CHAIRMAN AND CHIEF EXECUTIVE OFFICER
To my fellow stockholders,
Strong Strategic Rationale and Operational Fit for Anticipated Business Combination with ImmunogenX
The close of 2023 has been an exciting period for First Wave BioPharma, highlighted by the recently announced potential business combination with ImmunogenX. We recently announced a non-binding term sheet with ImmunogenX and are currently in negotiations for a definitive agreement. In the event this potential transaction is completed, we will gain access to Phase 3-ready latiglutenase, a potentially first-in-class, targeted, oral biotherapeutic for celiac disease, and a team of visionary scientists led by Jack Syage, Ph.D., who is expected to become our President and Chief Operating Officer, and Professor Chaitan Khosla, who completed the seminal work leading to the discovery of latiglutenase at Stanford University.
Any definitive agreement with respect to the potential transaction and completion of the transaction would be subject to approval by the respective parties to that definitive agreement, including approval by our board of directors and/or stockholders, approval by ImmunogenX's stockholders, various regulatory approvals, and the combined company having sufficient capital to carry out the planned businesses.
Concurrent Strategic Pharma Commercial Agreement and Institutional Investment Anticipated in 1H'24
Additionally, in the event the Company closes the potential ImmunogenX transaction, we would expect to concurrently announce a significant non-dilutive financial investment from a strategic global pharmaceutical company for commercial rights to latiglutenase in the United States and Canada, as well as financing commitments from several institutional investors to fund the drug's development. These expected investments are based on the potential of latiglutenase to be a first-to-market treatment for celiac disease, a GI-disorder that impacts approximately three million people in the U.S. and for which no approved pharmacologic treatment currently exists.
Latiglutenase: A Phase 3 Ready Asset for Celiac Disease Addressing a Major Unmet Clinical Need
The Phase 3 clinical development plan for latiglutenase has been reviewed by the GI Division of the U.S. Food and Drug Administration (FDA), with initiation of the Phase 3 trials expected in the second half of 2024. This timing could enable latiglutenase to enter the multibillion-dollar celiac disease market by 2027.
In the event the Company closes the potential transaction with ImmunogenX, First Wave BioPharma could become a Phase 3 company with a drug technology that, upon successful completion of the ...