UPDATED: First Wave BioPharma To Acquire ImmunogenX To Bolster Gastrointestinal-Focused Pipeline

Editor's Note: We have updated the story to correct Dr. Jack Syage's new title to President and Chief Operating Officer instead of Chief Medical Officer reported earlier.

First Wave BioPharma Inc FWBI has signed a non-binding term sheet to acquire ImmunogenX in an all-stock transaction with the combined company focused on advancing a pipeline for gastrointestinal (GI) diseases.

James Sapirstein will continue to serve as Chairman and CEO of First Wave BioPharma, with Dr. Jack Syage, CEO and co-founder of ImmunogenX, assuming the role of President and Chief Operating Officer. 

The transaction is expected to close in the first half of 2024. The financial terms of the transaction were not disclosed.

First Wave BioPharma anticipates a significant non-dilutive financial investment from a strategic global pharmaceutical company for commercial rights to latiglutenase in the U.S. and financing commitments from several institutional investors to fund development, which will be completed post-closing.

"We plan to immediately advance the regulatory, manufacturing, and clinical processes that would enable the initiation of the pivotal Phase 3 clinical trials of latiglutenase by the second half of 2024. This trajectory could enable latiglutenase to enter the multibillion-dollar celiac disease market by 2027," stated James Sapirstein 

Latiglutenase is an orally administered mixture of two minimally systemically absorbed gluten-specific recombinant proteases being developed as an oral biotherapeutic for celiac disease.

In Phase 2a and 2b clinical trials, latiglutenase was shown to mitigate gluten-induced intestinal mucosal injury and reduce the severity and frequency of symptoms in celiac disease patients.

The Phase 3 clinical development plan for latiglutenase was reviewed by the GI Division of the FDA at the end of the Phase 2 meeting with an agreed plan forward, with the initiation of the Phase 3 trials expected in the second half of 2024.

In September, First Wave BioPharma announced an agreement with Sanofi SA SNY to license Capeserod, a selective 5-HT4 receptor partial agonist, which First Wave will repurpose and develop for GI indications.

Last week, First Wave BioPharma's board approved a 1-for-20 reverse stock split, effective today.

Price Action: FWBI shares closed at $4.418 on Friday.